COOK Medical Zenith Spiral-Z AAA User manual
Zenith® Spiral-Z AAA Iliac Leg with the Z-Trak™ Introduction System
Instructions for Use
Iliakální rameno Zenith® Spiral-Z AAA se zaváděcím systémem Z-Trak™
Návod k použití
Zenith® Spiral-Z AAA iliaca-ben med Z-Trak™ indføringssystem
Brugsanvisning
Iliakaler Zenith® Spiral-Z AAA-Schenkel mit Z-Trak™ Einführsystem
Gebrauchsanweisung
Λαγόνιο σκέλος AAA Zenith® Spiral-Z με το σύστημα εισαγωγής Z-Trak™
Οδηγίες χρήσης
Rama ilíaca para AAA Zenith® Spiral-Z con el sistema de introducción Z-Trak™
Instrucciones de uso
Jambage iliaque Zenith® Spiral-Z AAA avec système d’introduction Z-Trak™
Mode d’emploi
Z-Trak™ felvezető rendszerrel ellátott Zenith® Spiral-Z AAA iliacaszár
Használati utasítás
Branca iliaca per endoprotesi addominale Zenith® Spiral-Z con sistema di introduzione Z-Trak™
Istruzioni per l’uso
Zenith® Spiral-Z AAA iliacale poot met het Z-Trak™ introductiesysteem
Gebruiksaanwijzing
Zenith® Spiral-Z AAA iliaca-ben med Z-Trak™ innføringssystem
Bruksanvisning
Odnoga biodrowa Zenith® Spiral-Z AAA z systemem wprowadzającym Z-Trak™
Instrukcja użycia
Extremidade ilíaca AAA Zenith® Spiral-Z com o sistema de introdução Z-Trak™
Instruções de utilização
Zenith® Spiral-Z AAA iliakaliskt graftben med Z-Trak™ införingssystem
Bruksanvisning
MEDICAL
*T_ZAAASZ_REV2*
EN
16
CS
21
DA
26
DE
31
EL
37
ES
43
FR
49
HU
55
IT
60
NL
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NO
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PL
77
PT
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SV
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ENGLISH
TABLE OF CONTENTS
Illustrations............................................................11-15
1 DEVICE DESCRIPTION .............................................16
1.1 Zenith Spiral-Z AAA Iliac Leg .......................................16
1.2 Delivery System....................................................16
2 INDICATIONS FOR USE ............................................16
3 CONTRAINDICATIONS.............................................16
4 WARNINGS AND PRECAUTIONS ...................................16
4.1 General ............................................................16
4.2 Patient Selection, Treatment and Follow-Up ........................16
4.3 Pre-Procedure Measurement Techniques and Imaging..............16
4.4 Device Selection .................................................16
4.5 Implant Procedure ...............................................17
4.6 Molding Balloon Use .............................................17
4.7 MRI Information ...................................................17
Static Magnetic Field ................................................ 17
MRI-Related Heating ................................................ 17
Image Artifact....................................................... 17
5 ADVERSE EVENTS.................................................17
5.1 Observed Adverse Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5.2 Potential Adverse Events ...........................................17
Device-Related Adverse Event Reporting ..........................17
6 SUMMARY OF CLINICAL STUDIES..................................17
7 PATIENT SELECTION AND TREATMENT .............................18
7.1 Individualization of Treatment .....................................18
8 PATIENT COUNSELING INFORMATION..............................18
9 HOW SUPPLIED...................................................18
10 CLINICAL USE INFORMATION.....................................18
10.1 Physician Training ................................................18
10.2 Inspection Prior to Use............................................18
10.3 Materials Required................................................18
10.4 Materials Recommended .........................................18
10.5 Device Diameter Sizing Guidelines ................................18
Table 10.5.1 Spiral-Z AAA Iliac Leg Graft Sizing Guide ..............18
11 DIRECTIONS FOR USE............................................19
Anatomical Requirements .........................................19
General Use Information .........................................19
Pre-Implant Determinants .........................................19
Patient Preparation................................................19
11.1 Zenith Spiral-Z AAA Iliac Leg System ..............................19
11.1.1 Contralateral Iliac Leg Preparation/Flush ....................19
11.1.2 Ipsilateral Iliac Leg Preparation/Flush........................19
11.1.3 Vascular Access and Angiography ...........................19
11.1.4 Contralateral Iliac Leg Placement and Deployment ..........19
11.1.5 Ipsilateral Iliac Leg Placement and Deployment .............19
11.1.6 Molding Balloon Insertion ..................................19
Final Angiogram .................................................20
12 IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP .........20
12.1 General ........................................................20
12.2 Additional Surveillance and Treatment...........................20
12.3 MRI Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Static Magnetic Field
MRI-Related Heating ............................................20
Image Artifact...................................................20
13 PATIENT TRACKING INFORMATION..............................20
ČESKY
OBSAH
Ilustrace .................................................................
11-15
1 POPIS ZAŘÍZENÍ ....................................................21
1.1 Iliakální rameno Zenith Spiral-Z AAA ................................. 21
1.2 Aplikační systém..................................................... 21
2 URČENÉ POUŽITÍ ...................................................21
3 KONTRAINDIKACE ..................................................21
4 VAROVÁNÍ A UPOZORNĚNÍ ..........................................21
4.1 Obecně.............................................................. 21
4.2 Výběr, léčba a následné kontroly pacienta ............................ 21
4.3 Měřicí techniky a zobrazování před výkonem......................... 21
4.4 Volba zařízení........................................................ 21
4.5 Postup implantace................................................... 22
4.6 Použití tvarovacího balónku.......................................... 22
4.7 Informace o vyšetření MRI ........................................... 22
Statické magnetické pole............................................ 22
Záhřev způsobený snímkováním MRI................................ 22
Artefakt obrazu ..................................................... 22
5 NEŽÁDOUCÍ PŘÍHODY ..............................................22
5.1 Zaznamenané nežádoucí příhody.................................... 22
5.2 Potenciální nežádoucí příhody ....................................... 22
Hlášení nežádoucích příhod souvisejících se zařízením. . . . . . . . . . . . . . . 22
6 SOUHRN KLINICKÝCH STUDIÍ........................................22
7 VÝBĚR A LÉČBA PACIENTA...........................................23
7.1 Individualizace léčby................................................. 23
8 PORADENSTVÍ PRO PACIENTY.......................................23
9 STAV PŘI DODÁNÍ...................................................23
10 INFORMACE O KLINICKÉM POUŽITÍ.................................23
10.1 Školení lékařů ...................................................... 23
10.2 Kontrola před použitím ............................................. 23
10.3 Požadovaný materiál ............................................... 23
10.4 Doporučený materiál ............................................... 23
10.5 Pokyny k určení průměru zařízení ................................... 23
Tabulka 10.5.1 Návod k určení velikosti iliakálního ramena graftu
Spiral-Z AAA ........................................................ 23
11 POKYNY K POUŽITÍ ................................................24
Anatomické požadavky ............................................. 24
Obecné informace o použití......................................... 24
Rozhodující činitele před implantací................................. 24
Příprava pacienta ................................................... 24
11.1 Systém iliakálního ramena Zenith Spiral-Z AAA...................... 24
11.1.1 Příprava a propláchnutí kontralaterálního iliakálního ramena...24
11.1.2 Příprava a propláchnutí ipsilaterálního iliakálního ramena ..... 24
11.1.3 Cévní přístup a angiografie ................................... 24
11.1.4 Umístění a rozvinutí kontralaterálního iliakálního ramena ..... 24
11.1.5 Umístění a rozvinutí ipsilaterálního iliakálního ramena ........ 24
11.1.6 Zavedení tvarovacího balónku................................ 24
Finální angiogram................................................... 25
12 POKYNY PRO SNÍMKOVÁNÍ A POOPERAČNÍ KONTROLU. . . . . . . . . . . . . .25
12.1 Obecně ............................................................ 25
12.2 Další sledování a léčba.............................................. 25
12.3 Informace o vyšetření MRI .......................................... 25
Statické magnetické pole ........................................... 25
Záhřev způsobený snímkováním MRI ............................... 25
Artefakt obrazu..................................................... 25
13 INFORMACE PRO SLEDOVÁNÍ PACIENTŮ ............................25
DANSK
INDHOLDSFORTEGNELSE
Illustrationer.............................................................
11-15
1 BESKRIVELSE AF PRODUKTET .......................................26
1.1 Zenith Spiral-Z AAA iliaca-ben ....................................... 26
1.2 Indføringssystem .................................................... 26
2 TILSIGTET ANVENDELSE ............................................26
3 KONTRAINDIKATIONER .............................................26
4 ADVARSLER OG FORHOLDSREGLER..................................26
4.1 Generelle ............................................................ 26
4.2 Patientudvælgelse, behandling og opfølgning ....................... 26
4.3 Måleteknik og billeddiagnostik før proceduren....................... 26
4.4 Udvælgelse af produkt............................................... 26
4.5 Implantationsprocedure ............................................. 27
4.6 Brug af formningsballon ............................................. 27
4.7 Information om MR-scanning ........................................ 27
Statisk magnetfelt................................................... 27
MR-relateret opvarmning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Billedartefakt........................................................ 27
5 UØNSKEDE HÆNDELSER ............................................27
5.1 Observerede uønskede hændelser ................................... 27
5.2 Potentielle uønskede hændelser ..................................... 27
Rapportering af uønskede hændelser i forbindelse
med anordningen................................................... 27
6 RESUME OVER KLINISKE UNDERSØGELSER...........................27
7 PATIENTUDVÆLGELSE OG BEHANDLING .............................28
7.1 Individualisering af behandling ...................................... 28
8 PATIENTRÅDGIVNINGSINFORMATION ...............................28
9 LEVERING ..........................................................28
10 INFORMATION OM KLINISK ANVENDELSE...........................28
10.1 Lægeuddannelse ................................................... 28
10.2 Inspektion inden brug .............................................. 28
10.3 Nødvendige materialer ............................................. 28
10.4 Anbefalede materialer .............................................. 28
10.5 Retningslinjer for bestemmelse af produktdiameter................. 28
Tabel 10.5.1 Størrelsesguide til Spiral-Z AAA iliaca-ben............... 28
11 BRUGSANVISNING. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
Anatomiske krav .................................................... 29
Generel information om anvendelse................................. 29
Afgørende faktorer før implantation ................................. 29
Klargøring af patienten.............................................. 29
11.1 Zenith Spiral-Z AAA iliaca-ben system............................... 29
11.1.1 Forberedelse/skylning af kontralateralt iliaca-ben ............. 29
11.1.2 Forberedelse/skylning af ipsilateralt iliaca-ben ................ 29
11.1.3 Vaskulær adgang og angiografi ............................... 29
11.1.4 Placering og ekspansion af kontralaterale iliaca-ben........... 29
11.1.5 Placering og ekspansion af det ipsilaterale iliaca-ben.......... 29
11.1.6 Indføring af formningsballon ................................. 29
Slutangiogram ...................................................... 30
12 RETNINGSLINJER FOR BILLEDDIAGNOSTIK OG POSTOPERATIV
OPFØLGNING .....................................................30
12.1 Generelle........................................................... 30
12.2 Yderligere kontrol og behandling ................................... 30
12.3 Information om MR-scanning....................................... 30
Statisk magnetfelt .................................................. 30
MR-relateret opvarmning ........................................... 30
Billedartefakt ....................................................... 30
13 OPLYSNINGER OM SPORING AF PATIENTER .........................30
DEUTSCH
INHALTSVERZEICHNIS
Abbildungen ............................................................
11-15
1 BESCHREIBUNG DES INSTRUMENTS .................................31
1.1 Iliakaler Zenith Spiral-Z AAA-Schenkel................................ 31
1.2 Einführsystem ....................................................... 31
2 VERWENDUNGSZWECK .............................................31
3 KONTRAINDIKATIONEN .............................................31
4 WARNHINWEISE UND VORSICHTSMASSNAHMEN.....................31
4.1 Allgemeines ......................................................... 31
4.2 Auswahl, Behandlung und Nachsorge der Patienten.................. 31
4.3 Messtechniken und Bildgebung vor dem Eingriff..................... 31
4.4 Auswahl der Prothese................................................ 32
4.5 Implantationsverfahren .............................................. 32
4.6 Verwendung des Modellierungsballons .............................. 32
4.7 MRT-Informationen .................................................. 32
Statisches Magnetfeld............................................... 32
MRT-bedingte Erwärmung .......................................... 32
Bildartefakt ......................................................... 32
5 UNERWÜNSCHTE EREIGNISSE .......................................32
5.1 Beobachtete unerwünschte Ereignisse ............................... 32
5.2 Mögliche unerwünschte Ereignisse .................................. 32
Melden prothesenbezogener unerwünschter Ereignisse ............. 33
6 ZUSAMMENFASSUNG DER KLINISCHEN STUDIEN.....................33
7 AUSWAHL UND BEHANDLUNG DER PATIENTEN.......................33
7.1 Individuelle Gestaltung der Behandlung ............................. 33
8 INFORMATIONEN ZUR AUFKLÄRUNG DES PATIENTEN.................33
9 LIEFERFORM .......................................................33
10 INFORMATIONEN ZUM KLINISCHEN EINSATZ........................33
10.1 Ärzteschulung...................................................... 33
10.2 Überprüfung vor dem Gebrauch.................................... 34
10.3 Erforderliche Materialien............................................ 34
10.4 Empfohlene Materialien ............................................ 34
10.5 Anleitung zur Durchmesserbestimmung der Prothese .............. 34
Tabelle 10.5.1 Anleitung zur Größenbestimmung des iliakalen
Spiral-Z AAA-Prothesenschenkels ................................... 34
11 GEBRAUCHSANWEISUNG ..........................................34
Anatomische Voraussetzungen...................................... 34
Allgemeine Informationen zum Gebrauch ........................... 34
Die Präimplantationsphase bestimmende Faktoren.................. 34
Vorbereitung des Patienten ......................................... 34
11.1 Iliakales Zenith Spiral-Z AAA-Schenkelsystem ....................... 34
11.1.1 Vorbereitung/Spülen des kontralateralen iliakalen Schenkels ..34
11.1.2 Vorbereitung/Spülen des ipsilateralen iliakalen Schenkels ..... 34
11.1.3 Gefäßzugang und Angiographie.............................. 34
11.1.4 Positionieren und Entfalten des kontralateralen iliakalen
Schenkels ........................................................... 34
11.1.5 Positionieren und Entfalten des ipsilateralen iliakalen
Schenkels ........................................................... 35
11.1.6 Einführen des Modellierungsballons .......................... 35
Abschließendes Angiogramm ....................................... 35
12 BILDGEBUNGSRICHTLINIEN UND NACHOPERATIVE VERSORGUNG ...35
12.1 Allgemeines ........................................................ 35
12.2 Zusätzliche Überwachung und Behandlung. . . . . . . . . . . . . . . . . . . . . . . . . 35
12.3 MRT-Informationen................................................. 36
Statisches Magnetfeld .............................................. 36
MRT-bedingte Erwärmung.......................................... 36
Bildartefakt......................................................... 36
13 INFORMATIONEN ZUR PATIENTENVERFOLGUNG ....................36
ΕΛΛΗΝΙΚΑ
ΠΙΝΑΚΑΣ ΠΕΡΙΕΧΟΜΕΝΩΝ
Απεικονίσεις .............................................................
11-15
1 ΠΕΡΙΓΡΑΦΗ ΤΗΣ ΣΥΣΚΕΥΗΣ .........................................37
1.1 Λαγόνιο σκέλος AAA Zenith Spiral-Z ................................. 37
1.2 Σύστημα τοποθέτησης............................................... 37
2 ΧΡΗΣΗ ΓΙΑ ΤΗΝ ΟΠΟΙΑ ΠΡΟΟΡΙΖΕΤΑΙ................................37
3 ΑΝΤΕΝ∆ΕΙΞΕΙΣ .....................................................37
4 ΠΡΟΕΙ∆ΟΠΟΙΗΣΕΙΣ ΚΑΙ ΠΡΟΦΥΛΑΞΕΙΣ...............................37
4.1 Γενικά ............................................................... 37
4.2 Επιλογή, θεραπεία και παρακολούθηση ασθενούς.................... 37
4.3 Τεχνικές μέτρησης και απεικόνιση πριν από τη διαδικασία ............ 37
4.4 Επιλογή συσκευής ................................................... 38
4.5 Διαδικασία εμφύτευσης.............................................. 38
4.6 Χρήση μπαλονιού διαμόρφωσης..................................... 38
4.7 Πληροφορίες μαγνητικής τομογραφίας .............................. 38
Στατικό μαγνητικό πεδίο ............................................ 38
Θέρμανση που σχετίζεται με τη μαγνητική τομογραφία.............. 38
Τέχνημα εικόνας .................................................... 38
5 ΑΝΕΠΙΘΥΜΗΤΕΣ ΕΝΕΡΓΕΙΕΣ .........................................38
5.1 Παρατηρούμενες ανεπιθύμητες ενέργειες ............................ 38
5.2 Δυνητικές ανεπιθύμητες ενέργειες ................................... 38
Αναφορά ανεπιθύμητων ενεργειών που σχετίζονται με τη συσκευή .. 39
6 ΠΕΡΙΛΗΨΗ ΤΩΝ ΚΛΙΝΙΚΩΝ ΜΕΛΕΤΩΝ................................39
7 ΕΠΙΛΟΓΗ ΚΑΙ ΘΕΡΑΠΕΙΑ ΑΣΘΕΝΩΝ ..................................39
7.1 Εξατομίκευση της θεραπείας......................................... 39
8 ΠΛΗΡΟΦΟΡΙΕΣ ΓΙΑ ΤΙΣ ΣΥΣΤΑΣΕΙΣ ΠΡΟΣ ΤΟΝ ΑΣΘΕΝΗ ...............39
9 ΤΡΟΠΟΣ ∆ΙΑΘΕΣΗΣ .................................................39
10 ΠΛΗΡΟΦΟΡΙΕΣ ΓΙΑ ΤΗΝ ΚΛΙΝΙΚΗ ΧΡΗΣΗ ...........................39
10.1 Εκπαίδευση ιατρού ................................................. 39
10.2 Επιθεώρηση πριν από τη χρήση .................................... 40
10.3 Απαιτούμενα υλικά ................................................. 40
10.4 Συνιστώμενα υλικά ................................................. 40
10.5 Οδηγίες επιλογής διαμέτρου συσκευής ............................. 40
Πίνακας 10.5.1 Οδηγός προσδιορισμού μεγέθους μοσχεύματος
λαγόνιου σκέλους AAA Spiral-Z...................................... 40
11 Ο∆ΗΓΙΕΣ ΧΡΗΣΗΣ .................................................40
Ανατομικές απαιτήσεις .............................................. 40
Γενικές πληροφορίες χρήσης ........................................ 40
Προσδιοριστικοί παράγοντες προ της εμφύτευσης .................. 40
Προετοιμασία ασθενούς ............................................ 40
11.1 Σύστημα λαγόνιου σκέλος AAA Zenith Spiral-Z...................... 40
11.1.1 Προετοιμασία/Έκπλυση ετερόπλευρου λαγόνιου σκέλους..... 40
11.1.2 Προετοιμασία/Έκπλυση σύστοιχου λαγόνιου σκέλους......... 40
11.1.3 Αγγειακή προσπέλαση και αγγειογραφία ...................... 40
11.1.4 Τοποθέτηση και έκπτυξη ετερόπλευρου λαγόνιου σκέλους.... 41
11.1.5 Τοποθέτηση και έκπτυξη σύστοιχου λαγόνιου σκέλους ........ 41
11.1.6 Εισαγωγή μπαλονιού διαμόρφωσης........................... 41
Τελική αγγειογραφία ................................................ 41
12 ΚΑΤΕΥΘΥΝΤΗΡΙΕΣ Ο∆ΗΓΙΕΣ ΑΠΕΙΚΟΝΙΣΗΣ ΚΑΙ ΜΕΤΕΓΧΕΙΡΗΤΙΚΗ
ΠΑΡΑΚΟΛΟΥΘΗΣΗ ................................................41
12.1 Γενικά .............................................................. 41
12.2 Επιπλέον παρακολούθηση και θεραπεία ............................ 42
12.3 Πληροφορίες μαγνητικής τομογραφίας ............................. 42
Στατικό μαγνητικό πεδίο............................................ 42
Θέρμανση που σχετίζεται με τη μαγνητική τομογραφία ............. 42
Τέχνημα εικόνας .................................................... 42
13 ΠΛΗΡΟΦΟΡΙΕΣ ΠΑΡΑΚΟΛΟΥΘΗΣΗΣ ΑΣΘΕΝΩΝ .....................42
ESPAÑOL
ÍNDICE
Ilustraciones .............................................................
11-15
1 DESCRIPCIÓN DEL DISPOSITIVO .....................................43
1.1 Rama ilíaca para AAA Zenith Spiral-Z................................. 43
1.2 Sistema de implantación............................................. 43
2 INDICACIONES .....................................................43
3 CONTRAINDICACIONES .............................................43
4 ADVERTENCIAS Y PRECAUCIONES ...................................43
4.1 Generales............................................................ 43
4.2 Selección, tratamiento y seguimiento de los pacientes ............... 43
4.3 Técnicas de medición y estudios de imagen previos
al procedimiento ........................................................ 43
4.4 Selección de los dispositivos ......................................... 44
4.5 Procedimiento de implantación ...................................... 44
4.6 Uso del balón moldeador ............................................ 44
4.7 Información sobre la MRI. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Campo magnético estático.......................................... 44
Calentamiento relacionado con la MRI............................... 44
Artefacto de la imagen .............................................. 44
5 REACCIONES ADVERSAS ............................................44
5.1 Reacciones adversas observadas ..................................... 44
5.2 Reacciones adversas posibles ........................................ 44
Informes de reacciones adversas relacionadas con el dispositivo ..... 45
6 RESUMEN DE ESTUDIOS CLÍNICOS...................................45
7 SELECCIÓN Y TRATAMIENTO DE LOS PACIENTES ......................45
7.1 Individualización del tratamiento .................................... 45
8 INFORMACIÓN PARA EL ASESORAMIENTO DE LOS PACIENTES. . . . . . . . .45
9 PRESENTACIÓN.....................................................45
10 INFORMACIÓN SOBRE EL USO CLÍNICO .............................45
10.1 Formación de médicos ............................................. 45
10.2 Inspección previa al uso ............................................ 45
10.3 Material necesario .................................................. 46
10.4 Material recomendado ............................................. 46
10.5 Pautas para la selección del tamaño del diámetro de
los dispositivos .......................................................... 46
Tabla 10.5.1 Guía para la selección del tamaño de las ramas
ilíacas para AAA Spiral-Z............................................. 46
11 MODO DE EMPLEO ................................................46
Requisitos anatómicos .............................................. 46
Información general sobre el uso.................................... 46
Factores determinantes previos al implante ......................... 46
Preparación del paciente............................................ 46
11.1 Sistema de la rama ilíaca para AAA Zenith Spiral-Z .................. 46
11.1.1 Preparación y lavado de la rama ilíaca contralateral ........... 46
11.1.2 Preparación y lavado de la rama ilíaca ipsilateral .............. 46
11.1.3 Acceso vascular y angiografía ................................. 46
11.1.4 Colocación y despliegue de la rama ilíaca contralateral ........ 46
11.1.5 Colocación y despliegue de la rama ilíaca ipsilateral........... 47
11.1.6 Introducción del balón moldeador............................ 47
Angiografía final .................................................... 47
12 PAUTAS PARA LOS ESTUDIOS DE IMAGEN Y SEGUIMIENTO
POSOPERATORIO..................................................47
12.1 Generales .......................................................... 47
12.2 Vigilancia y tratamiento adicionales................................. 47
12.3 Información sobre la MRI ........................................... 47
Campo magnético estático ......................................... 47
Calentamiento relacionado con la MRI .............................. 47
Artefacto de la imagen ............................................. 48
13 INFORMACIÓN PARA LA LOCALIZACIÓN DEL PACIENTE..............48
FRANÇAIS
TABLE DES MATIÈRES
Illustrations..............................................................
11-15
1 DESCRIPTION DU DISPOSITIF........................................49
1.1 Jambage iliaque Zenith Spiral-Z AAA................................. 49
1.2 Système de largage.................................................. 49
2 UTILISATION .......................................................49
3 CONTRE-INDICATIONS ..............................................49
4 AVERTISSEMENTS ET MISES EN GARDE ..............................49
4.1 Généralités .......................................................... 49
4.2 Sélection, traitement et suivi des patients ............................ 49
4.3 Techniques de mesure et imagerie avant l’intervention ............... 49
4.4 Sélection des dispositifs.............................................. 50
4.5 Méthode d’implantation ............................................. 50
4.6 Utilisation du ballonnet de modelage ................................ 50
4.7 Informations relatives aux IRM ....................................... 50
Champ magnétique statique ........................................ 50
Échauffement lié à l’IRM............................................. 50
Artéfact de l’image .................................................. 50
5 ÉVÉNEMENTS INDÉSIRABLES........................................50
5.1 Événements indésirables observés ................................... 50
5.2 Événements indésirables possibles................................... 50
Rapport d’événement indésirable associé au dispositif............... 51
6 SOMMAIRE DES ÉTUDES CLINIQUES .................................51
7 SÉLECTION ET TRAITEMENT DES PATIENTS ...........................51
7.1 Individualisation du traitement ...................................... 51
8 CONSEILS AUX PATIENTS............................................51
9 PRÉSENTATION .....................................................51
10 UTILISATION CLINIQUE ............................................51
10.1 Formation clinique ................................................. 51
10.2 Inspection avant l’utilisation ........................................ 51
10.3 Matériel requis ..................................................... 51
10.4 Matériel recommandé .............................................. 52
10.5 Directives de mesures du diamètre du dispositif .................... 52
Tableau 10.5.1 Guide de mesures de l’endoprothèse de
jambage iliaque Spiral-Z AAA ....................................... 52
11 DIRECTIVES D’UTILISATION ........................................52
Exigences anatomiques ............................................. 52
Informations générales sur l’utilisation .............................. 52
Facteurs déterminants avant l’implantation.......................... 52
Préparation du patient .............................................. 52
11.1 Système de jambage iliaque Zenith Spiral-Z AAA.................... 52
11.1.1 Préparation et rinçage du jambage iliaque controlatéral....... 52
11.1.2 Préparation et rinçage du jambage iliaque homolatéral ....... 52
11.1.3 Accès vasculaire et angiographie. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
11.1.4 Mise en place et déploiement du jambage
iliaque controlatéral................................................. 52
11.1.5 Mise en place et déploiement du jambage
iliaque homolatéral ................................................. 53
11.1.6 Insertion du ballonnet de modelage .......................... 53
Angiographie finale ................................................. 53
12 DIRECTIVES D’IMAGERIE ET SUIVI POST-OPÉRATOIRE. . . . . . . . . . . . . . . .53
12.1 Généralités ......................................................... 53
12.2 Surveillance et traitement complémentaires ........................ 53
12.3 Informations relatives aux IRM ...................................... 53
Champ magnétique statique ....................................... 53
Échauffement lié à l’IRM ............................................ 53
Artéfact de l’image ................................................. 54
13 INFORMATIONS RELATIVES AU SUIVI DU PATIENT ...................54
MAGYAR
TARTALOMJEGYZÉK
Illusztrációk..............................................................
11-15
1 AZ ESZKÖZ LEÍRÁSA ................................................55
1.1 Zenith Spiral-Z AAA iliacaszár ........................................ 55
1.2 Bejuttató rendszer ................................................... 55
2 HASZNÁLATI JAVALLATOK ..........................................55
3 ELLENJAVALLATOK .................................................55
4 FIGYELMEZTETÉSEK ÉS ÓVINTÉZKEDÉSEK ...........................55
4.1 Általános ............................................................ 55
4.2 A betegek kiválasztása, kezelése és utánkövetése .................... 55
4.3 A beavatkozást megelőzően alkalmazott mérési technikák
és leképezés............................................................. 55
4.4 Az eszköz kiválasztása ............................................... 56
4.5 Beültetési eljárás..................................................... 56
4.6 A formázóballon használata.......................................... 56
4.7 Mágneses rezonanciára vonatkozó információk ...................... 56
Sztatikus mágneses tér erőssége .................................... 56
MRI-vel kapcsolatos hőmérséklet-emelkedés ........................ 56
Képműtermék....................................................... 56
5 NEMKÍVÁNATOS ESEMÉNYEK........................................56
5.1 Megfigyelt nemkívánatos események ................................ 56
5.2 Lehetséges nemkívánatos események................................ 56
Az eszközzel kapcsolatos nemkívánatos események bejelentése ..... 57
6 KLINIKAI VIZSGÁLATOK ÖSSZEFOGLALÁSA ..........................57
7 A BETEGEK KIVÁLASZTÁSA ÉS KEZELÉSE .............................57
7.1 A kezelés egyénivé tétele ............................................ 57
8 BETEGTÁJÉKOZTATÁS...............................................57
9 KISZERELÉS ........................................................57
10 KLINIKAI FELHASZNÁLÁSSAL KAPCSOLATOS INFORMÁCIÓ..........57
10.1 Orvosképzés........................................................ 57
10.2 Használat előtti szemle ............................................. 57
10.3 Szükséges anyagok................................................. 57
10.4 Ajánlott anyagok ................................................... 57
10.5 Az eszközök átmérőjének méretezési irányelvei ..................... 58
10.5.1. táblázat: A Spiral-Z AAA iliacaszárgraft méretezési
útmutatója.......................................................... 58
11 HASZNÁLATI UTASÍTÁS ............................................58
Anatómiai követelmények........................................... 58
A felhasználással kapcsolatos általános információk ................. 58
Implantáció előtti meghatározó elemek ............................. 58
A beteg előkészítése ................................................ 58
11.1 Zenith Spiral-Z AAA iliacaszárrendszer .............................. 58
11.1.1 A kontralaterális iliacaszár előkészítése és öblítése. . . . . . . . . . . . . 58
11.1.2 Az ipsilaterális iliacaszár előkészítése és öblítése............... 58
11.1.3 Vaszkuláris hozzáférés és angiográfia.......................... 58
11.1.4 A kontralaterális iliacaszár elhelyezése és telepítése ........... 58
11.1.5 Az ipsilateralis iliacaszár elhelyezése és telepítése ............. 58
11.1.6 A formázóballon felvezetése .................................. 59
Végső angiogram ................................................... 59
12 LEKÉPEZÉSI IRÁNYELVEK ÉS POSZTOPERATÍV UTÁNKÖVETÉS ........59
12.1 Általános ........................................................... 59
12.2 További felügyelet és kezelés ....................................... 59
12.3 Mágneses rezonanciára vonatkozó információk ..................... 59
Sztatikus mágneses tér erőssége.................................... 59
MRI-vel kapcsolatos hőmérséklet-emelkedés........................ 59
Képműtermék ...................................................... 59
13 A BETEGEK NYOMONKÖVETÉSÉRE VONATKOZÓ INFORMÁCIÓ .......59
ITALIANO
INDICE
Illustrazioni ..............................................................
11-15
1 DESCRIZIONE DEL DISPOSITIVO .....................................60
1.1 Branca iliaca per endoprotesi addominale Zenith Spiral-Z ............ 60
1.2 Sistema di inserimento............................................... 60
2 INDICAZIONI PER L’USO.............................................60
3 CONTROINDICAZIONI...............................................60
4 AVVERTENZE E PRECAUZIONI .......................................60
4.1 Informazioni generali ................................................ 60
4.2 Selezione, trattamento e follow-up del paziente...................... 60
4.3 Tecniche preoperatorie di misurazione e imaging .................... 60
4.4 Selezione del dispositivo............................................. 61
4.5 Procedura di impianto ............................................... 61
4.6 Uso del palloncino dilatatore......................................... 61
4.7 Informazioni sulle procedure MRI .................................... 61
Campo magnetico statico ........................................... 61
Riscaldamento correlato all’MRI ..................................... 61
Artefatti d’immagine ................................................ 61
5 EVENTI NEGATIVI ...................................................61
5.1 Eventi negativi osservati ............................................. 61
5.2 Possibili eventi negativi .............................................. 61
Notifica degli eventi negativi correlati al dispositivo ................. 62
6 RIEPILOGO DEGLI STUDI CLINICI.....................................62
7 SELEZIONE E TRATTAMENTO DEI PAZIENTI ...........................62
7.1 Requisiti per il trattamento........................................... 62
8 INFORMAZIONI DA FORNIRE AI PAZIENTI ............................62
9 CONFEZIONAMENTO. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62
10 INFORMAZIONI PER USO CLINICO ..................................62
10.1 Programma di formazione per il medico ............................ 62
10.2 Esame prima dell’uso ............................................... 63
10.3 Materiali necessari.................................................. 63
10.4 Materiali consigliati................................................. 63
10.5 Linee guida per la determinazione del diametro idoneo
del dispositivo........................................................... 63
Tabella 10.5.1 Guida alla determinazione delle dimensioni idonee
della branca iliaca per endoprotesi addominale Spiral-Z ............. 63
11 ISTRUZIONI PER L’USO.............................................63
Requisiti anatomici.................................................. 63
Informazioni generali sull’impiego................................... 63
Fattori da considerare in sede preliminare ........................... 63
Preparazione del paziente........................................... 63
11.1 Sistema con branca iliaca per endoprotesi addominale
Zenith Spiral-Z .......................................................... 63
11.1.1 Preparazione/lavaggio della branca iliaca controlaterale....... 63
11.1.2 Preparazione/lavaggio della branca iliaca ipsilaterale.......... 63
11.1.3 Accesso vascolare e angiografia............................... 63
11.1.4 Posizionamento e rilascio della branca iliaca controlaterale.... 63
11.1.5 Posizionamento e rilascio della branca iliaca ipsilaterale ....... 64
11.1.6 Inserimento del palloncino dilatatore ......................... 64
Angiogramma conclusivo ........................................... 64
12 LINEE GUIDA PER LE TECNICHE DI IMAGING E IL FOLLOW-UP
POSTOPERATORIO. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64
12.1 Informazioni generali ............................................... 64
12.2 Ulteriori esami di controllo e trattamento ........................... 64
12.3 Informazioni sulle procedure MRI ................................... 64
Campo magnetico statico. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Riscaldamento correlato all’MRI..................................... 65
Artefatti d’immagine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
13 INFORMAZIONI DOCUMENTANTI IL DISPOSITIVO ...................65
NEDERLANDS
INHOUD
Afbeeldingen............................................................
11-15
1 BESCHRIJVING VAN HET HULPMIDDEL...............................66
1.1 Zenith Spiral-Z AAA iliacale poot ..................................... 66
1.2 Plaatsingssysteem ................................................... 66
2 INDICATIES VOOR GEBRUIK .........................................66
3 CONTRA-INDICATIES................................................66
4 WAARSCHUWINGEN EN VOORZORGSMAATREGELEN .................66
4.1 Algemeen ........................................................... 66
4.2 Selectie, behandeling en controle van de patiënt..................... 66
4.3 Preprocedurele meettechnieken en beeldvorming ................... 66
4.4 Selectie van het hulpmiddel ......................................... 67
4.5 De implantatieprocedure ............................................ 67
4.6 Gebruik van de modelleerballon ..................................... 67
4.7 MRI-informatie....................................................... 67
Statisch magnetisch veld............................................ 67
MRI-gerelateerde opwarming ....................................... 67
Beeldartefact. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
5 ONGEWENSTE VOORVALLEN ........................................67
5.1 Waargenomen ongewenste voorvallen............................... 67
5.2 Mogelijke ongewenste voorvallen ................................... 67
Melding van prothesegerelateerde ongewenste voorvallen.......... 68
6 SAMENVATTING VAN KLINISCHE STUDIES............................68
7 SELECTIE EN BEHANDELING VAN DE PATIËNT ........................68
7.1 Individualisering van de behandeling ................................ 68
8 INFORMATIE VOOR DE PATIËNT......................................68
9 WIJZE VAN LEVERING ...............................................68
10 INFORMATIE OVER HET KLINISCHE GEBRUIK ........................68
10.1 Opleiding van de arts............................................... 68
10.2 Inspectie voorafgaand aan gebruik ................................. 68
10.3 Benodigde materialen .............................................. 68
10.4 Aanbevolen materialen............................................. 68
10.5 Leidraad voor het bepalen van de diameter van het hulpmiddel .... 69
Tabel 10.5.1 Spiral-Z AAA iliacale poot – leidraad voor het bepalen
van de maat ........................................................ 69
11 GEBRUIKSAANWIJZING ............................................69
Anatomische vereisten .............................................. 69
Algemene gebruiksinformatie....................................... 69
Bepalende factoren vóór de implantatie............................. 69
Voorbereiding van de patiënt ....................................... 69
11.1 Zenith Spiral-Z AAA iliacaal pootsysteem ........................... 69
11.1.1 Voorbereiding/spoelen van de contralaterale iliacale poot..... 69
11.1.2 Voorbereiding/spoelen van de ipsilaterale iliacale poot........ 69
11.1.3 Vasculaire introductie en angiografie.......................... 69
11.1.4 Plaatsing en ontplooiing van de contralaterale iliacale poot ... 69
11.1.5 Plaatsing en ontplooiing van de ipsilaterale iliacale poot ...... 69
11.1.6 Introductie van de modelleerballon........................... 70
Afrondend angiogram .............................................. 70
12 RICHTLIJNEN VOOR BEELDVORMEND ONDERZOEK EN
POSTOPERATIEVE CONTROLE ......................................70
12.1 Algemeen .......................................................... 70
12.2 Extra controle en behandeling...................................... 70
12.3 MRI-informatie ..................................................... 70
Statisch magnetisch veld ........................................... 70
MRI-gerelateerde opwarming....................................... 70
Beeldartefact ....................................................... 71
13 INFORMATIE PATIËNTVOLGSYSTEEM ...............................71
NORSK
INNHOLDSFORTEGNELSE
Illustrasjoner.............................................................
11-15
1 BESKRIVELSE AV ANORDNINGEN ....................................72
1.1 Zenith Spiral-Z AAA iliaca-ben ....................................... 72
1.2 Innføringssystem .................................................... 72
2 BRUKSOMRÅDER ...................................................72
3 KONTRAINDIKASJONER.............................................72
4 ADVARSLER OG FORHOLDSREGLER..................................72
4.1 Generelt ............................................................. 72
4.2 Pasientutvelgelse, behandling og oppfølging ........................ 72
4.3 Målingsteknikker og avbilding før prosedyren........................ 72
4.4 Valg av anordning ................................................... 72
4.5 Implantasjon ........................................................ 73
4.6 Bruk av formingsballong............................................. 73
4.7 MR-informasjon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Statisk magnetfelt................................................... 73
MR-relatert oppvarming............................................. 73
Bildeartefakt ........................................................ 73
5 UØNSKEDE HENDELSER.............................................73
5.1 Observerte uønskede hendelser ..................................... 73
5.2 Mulige uønskede hendelser.......................................... 73
Rapportering av anordningsrelaterte uønskede hendelser ........... 73
6 OVERSIKT OVER KLINISKE STUDIER..................................73
7 PASIENTUTVELGELSE OG BEHANDLING..............................74
7.1 Individualisering av behandlingen ................................... 74
8 PASIENTRÅDGIVNING...............................................74
9 LEVERINGSFORM ...................................................74
10 INFORMASJON OM KLINISK ANVENDELSE ..........................74
10.1 Legeopplæring ..................................................... 74
10.2 Inspeksjon før bruk ................................................. 74
10.3 Nødvendige materialer ............................................. 74
10.4 Anbefalte materialer................................................ 74
10.5 Retningslinjer for størrelsesmåling av anordningens diameter ....... 74
Tabell 10.5.1 Veiledning for valg av størrelse for Spiral-Z
AAA iliaca-benimplantat ............................................ 74
11 BRUKSVEILEDNING................................................75
Anatomiske krav .................................................... 75
Generell bruksinformasjon .......................................... 75
Avgjørende faktorer før implantasjonen ............................. 75
Klargjøring av pasienten ............................................ 75
11.1 Zenith Spiral-Z AAA iliaca-bensystem ............................... 75
11.1.1 Forberedelse/skylling av kontralateralt iliaca-ben.............. 75
11.1.2 Forberedelse/skylling av ipsilateralt iliaca-ben................. 75
11.1.3 Vaskulær tilgang og angiografi................................ 75
11.1.4 Plassering og anleggelse av kontralateralt iliaca-ben .......... 75
11.1.5 Plassering og anleggelse av ipsilateralt iliaca-ben ............. 75
11.1.6 Innføring av formingsballong ................................. 75
Sluttangiogram ..................................................... 76
12 RETNINGSLINJER FOR AVBILDING OG POSTOPERATIV OPPFØLGING ..76
12.1 Generelt............................................................ 76
12.2 Ytterligere kontroll og behandling .................................. 76
12.3 MR-informasjon .................................................... 76
Statisk magnetfelt .................................................. 76
MR-relatert oppvarming ............................................ 76
Bildeartefakt........................................................ 76
13 INFORMASJON FOR SPORING AV PASIENT ..........................76
POLSKI
SPIS TREŚCI
Ilustracje ................................................................
11-15
1 OPIS URZĄDZENIA..................................................77
1.1 Odnoga biodrowa Zenith Spiral-Z AAA............................... 77
1.2 System podawania................................................... 77
2 WSKAZANIA DO STOSOWANIA ......................................77
3 PRZECIWWSKAZANIA...............................................77
4 OSTRZEŻENIA I ŚRODKI OSTROŻNOŚCI ..............................77
4.1 Ogólne .............................................................. 77
4.2 Wybór pacjentów, leczenie i kontrola po zabiegu..................... 77
4.3 Techniki pomiarów przedoperacyjnych i obrazowanie................ 77
4.4 Wybór urządzenia ................................................... 78
4.5 Procedura wszczepiania.............................................. 78
4.6 Użycie balonu kształtującego ........................................ 78
4.7 Informacje dotyczące RM ............................................ 78
Statyczne pole magnetyczne ........................................ 78
Nagrzewanie związane z RM ........................................ 78
Artefakt obrazu ..................................................... 78
5 ZDARZENIA NIEPOŻĄDANE .........................................78
5.1 Obserwowane zdarzenia niepożądane ............................... 78
5.2 Potencjalne zdarzenia niepożądane .................................. 78
Zgłaszanie zdarzeń niepożądanych związanych z urządzeniem ...... 79
6 STRESZCZENIE BADAŃ KLINICZNYCH ................................79
7 DOBÓR I LECZENIE PACJENTÓW .....................................79
7.1 Indywidualizacja leczenia ............................................ 79
8 INFORMACJE O PROWADZENIU PACJENTA ...........................79
9 SPOSÓB DOSTARCZENIA ............................................79
10 INFORMACJE DOTYCZĄCE ZASTOSOWANIA KLINICZNEGO...........79
10.1 Szkolenie lekarza ................................................... 79
10.2 Kontrola przed użyciem ............................................ 79
10.3 Wymagane materiały ............................................... 79
10.4 Materiały zalecane.................................................. 80
10.5 Wskazówki doboru średnicy urządzenia............................. 80
Tabela 10.5.1 Wskazówki doboru rozmiaru stent-graftu
odnogi biodrowej Spiral-Z AAA...................................... 80
11 INSTRUKCJA UŻYCIA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80
Wymagania anatomiczne ........................................... 80
Ogólne informacje o stosowaniu .................................... 80
Przedimplantacyjne czynniki determinujące ......................... 80
Przygotowanie pacjenta............................................. 80
11.1 System odnogi biodrowej Zenith Spiral-Z AAA ...................... 80
11.1.1 Przygotowanie/przepłukiwanie przeciwstronnej
odnogi biodrowej ................................................... 80
11.1.2 Przygotowanie/przepłukiwanie tożsamostronnej
odnogi biodrowej ................................................... 80
11.1.3 Dostęp naczyniowy i angiografia ............................. 80
11.1.4 Umieszczanie i rozprężanie przeciwstronnej
odnogi biodrowej ................................................... 80
11.1.5 Umieszczanie i rozprężanie tożsamostronnej
odnogi biodrowej ................................................... 81
11.1.6 Wprowadzenie balonu kształtującego......................... 81
Angiogram końcowy ................................................ 81
12 WSKAZÓWKI DOTYCZĄCE OBRAZOWANIA I KONTROLA PO ZABIEGU ..81
12.1 Ogólne ............................................................. 81
12.2 Dodatkowa obserwacja i leczenie pacjentów........................ 81
12.3 Informacje dotyczące RM ........................................... 81
Statyczne pole magnetyczne ....................................... 81
Nagrzewanie związane z RM ........................................ 81
Artefakt obrazu..................................................... 82
13 INFORMACJE DOTYCZĄCE OBSERWACJI PACJENTÓW................82
PORTUGUÊS
ÍNDICE
Ilustrações...............................................................
11-15
1 DESCRIÇÃO DO DISPOSITIVO........................................83
1.1 Extremidade ilíaca AAA Zenith Spiral-Z............................... 83
1.2 Sistema de colocação ................................................ 83
2 INDICAÇÕES DE UTILIZAÇÃO ........................................83
3 CONTRA-INDICAÇÕES...............................................83
4 ADVERTÊNCIAS E PRECAUÇÕES .....................................83
4.1 Geral ................................................................ 83
4.2 Selecção, tratamento e seguimento dos doentes ..................... 83
4.3 Técnicas de medição e imagiologia antes do procedimento .......... 83
4.4 Escolha do dispositivo ............................................... 84
4.5 Procedimento de implantação ....................................... 84
4.6 Utilização do balão de moldagem.................................... 84
4.7 Informação sobre RMN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Campo magnético estático.......................................... 84
Aquecimento relacionado com RMN ................................ 84
Artefactos de imagem............................................... 84
5 EFEITOS ADVERSOS.................................................84
5.1 Efeitos adversos observados ......................................... 84
5.2 Efeitos adversos potenciais. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Relato de efeitos adversos relacionados com o dispositivo ........... 85
6 SÍNTESE DOS ESTUDOS CLÍNICOS....................................85
7 SELECÇÃO E TRATAMENTO DE DOENTES .............................85
7.1 Individualização do tratamento ...................................... 85
8 INFORMAÇÃO DE ACONSELHAMENTO AOS DOENTES.................85
9 APRESENTAÇÃO ....................................................85
10 INFORMAÇÃO PARA UTILIZAÇÃO CLÍNICA ..........................85
10.1 Formação de médicos .............................................. 85
10.2 Inspecção antes da utilização ....................................... 85
10.3 Materiais necessários ............................................... 85
10.4 Materiais recomendados. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
10.5 Orientações para escolha do diâmetro dos dispositivos ............. 86
Tabela 10.5.1 Guia de escolha do tamanho/diâmetro da
extremidade ilíaca da prótese AAA Spiral-Z .......................... 86
11 INSTRUÇÕES DE UTILIZAÇÃO ......................................86
Requisitos anatómicos .............................................. 86
Informação geral sobre a utilização.................................. 86
Factores determinantes antes da implantação ....................... 86
Preparação do doente............................................... 86
11.1 Sistema da extremidade ilíaca AAA Zenith Spiral-Z .................. 86
11.1.1 Preparação/irrigação da extremidade ilíaca contralateral ...... 86
11.1.2 Preparação/irrigação da extremidade ilíaca homolateral....... 86
11.1.3 Acesso vascular e angiografia................................. 86
11.1.4 Colocação e expansão da extremidade ilíaca contralateral..... 86
11.1.5 Colocação e expansão da extremidade ilíaca homolateral ..... 87
11.1.6 Inserção do balão de moldagem.............................. 87
Angiograma final.................................................... 87
12 ORIENTAÇÕES RELATIVAS À IMAGIOLOGIA E AO SEGUIMENTO
PÓS-OPERATÓRIO .................................................87
12.1 Geral ............................................................... 87
12.2 Vigilância e tratamento adicionais .................................. 87
12.3 Informação sobre RMN ............................................. 87
Campo magnético estático ......................................... 87
Aquecimento relacionado com RMN................................ 87
Artefactos de imagem .............................................. 88
13 INFORMAÇÃO SOBRE A LOCALIZAÇÃO DE DOENTES ................88
SVENSKA
INNEHÅLLSFÖRTECKNING
Illustrationer.............................................................
11-15
1 PRODUKTBESKRIVNING.............................................89
1.1 Zenith Spiral-Z AAA iliakaliskt graftben............................... 89
1.2 Införingssystem...................................................... 89
2 AVSEDD ANVÄNDNING .............................................89
3 KONTRAINDIKATIONER .............................................89
4 VARNINGAR OCH FÖRSIKTIGHETSÅTGÄRDER ........................89
4.1 Allmänt.............................................................. 89
4.2 Patienturval, behandling och uppföljning ............................ 89
4.3 Mättekniker och bildtagning före proceduren ........................ 89
4.4 Val av anordning..................................................... 90
4.5 Implantationsförfarande ............................................. 90
4.6 Användning av formningsballong.................................... 90
4.7 MRT-information..................................................... 90
Statiskt magnetfält .................................................. 90
MRT-relaterad uppvärmning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Bildartefakt ......................................................... 90
5 BIVERKNINGAR.....................................................90
5.1 Observerade biverkningar ........................................... 90
5.2 Eventuella biverkningar.............................................. 90
Rapportering av biverkningar som har samband med anordningen.. 90
6 SAMMANFATTNING AV KLINISKA STUDIER ...........................91
7 PATIENTURVAL OCH BEHANDLING. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91
7.1 Individualisering av behandlingen ................................... 91
8 PATIENTRÅDGIVNING...............................................91
9 LEVERANSFORM....................................................91
10 INFORMATION OM KLINISK ANVÄNDNING ..........................91
10.1 Läkarens utbildning ................................................ 91
10.2 Besiktning före användning......................................... 91
10.3 Material som behövs ............................................... 91
10.4 Rekommenderat material........................................... 91
10.5 Riktlinjer för storleksbestämning av anordningsdiametrar ........... 91
Tabell 10.5.1 Storleksbestämningsguide för Spiral-Z
AAA iliakaliskt graftben ............................................. 92
11 BRUKSANVISNING.................................................92
Anatomiska krav .................................................... 92
Allmän information ................................................. 92
Avgöranden före implantation ...................................... 92
Förberedelse av patienten........................................... 92
11.1 Zenith Spiral-Z AAA iliakaliskt graftbenssystem ..................... 92
11.1.1 Förberedning/spolning av kontralateralt iliakaliskt graftben ... 92
11.1.2 Förberedning/spolning av ipsilateralt iliakaliskt graftben ...... 92
11.1.3 Kärlåtkomst och angiografi ................................... 92
11.1.4 Placering och utplacering av det kontralaterala
iliakaliska graftbenet ................................................ 92
11.1.5 Placering och utplacering av det ipsilaterala
iliakaliska graftbenet ................................................ 92
11.1.6 Införing av formningsballong ................................. 92
Slutligt angiogram .................................................. 93
12 RIKTLINJER FÖR BILDFRAMSTÄLLNING OCH POSTOPERATIV
UPPFÖLJNING ....................................................93
12.1 Allmänt ............................................................ 93
12.2 Ytterligare övervakning och behandling ............................ 93
12.3 MRT-information ................................................... 93
Statiskt magnetfält ................................................. 93
MRT-relaterad uppvärmning ........................................ 93
Bildartefakt......................................................... 93
13 PATIENTSPÅRNINGSINFORMATION .................................93
Illustrations • Ilustrace • Illustrationer • Abbildungen • Απεικονίσεις • Ilustraciones • Illustrations • Illusztrációk • Illustrazioni • Afbeeldingen • Illustrasjoner • Ilustracje • Ilustrações • Illustrationer
11
1. Iliac Legs
2. Gold Radiopaque Markers (4)
3. Suprarenal Stent
4. Main Body
5. Gold Radiopaque Marker
1. Iliakální ramena
2. Zlaté rentgenokontrastní značky (4)
3. Suprarenální stent
4. Hlavní tělo
5. Zlatá rentgenkontrastní značka
1. Iliaca-ben
2. Røntgenfaste guldmarkører (4)
3. Suprarenal stent
4. Hovedprotese
5. Røntgenfast guldmarkør
1. Iliakale Schenkel
2. Röntgendichte Goldmarkierungen (4)
3. Suprarenaler Stent
4. Hauptteil
5. Röntgendichte Goldmarkierung
1. Λαγόνια σκέλη
2. Χρυσοί ακτινοσκιεροί δείκτες (4)
3. Επινεφρική ενδοπρόσθεση
4. Κύριο σώμα
5. Χρυσός ακτινοσκιερός δείκτης
1. Ramas ilíacas
2. Marcadores radiopacos de oro (4)
3. Stent suprarrenal
4. Cuerpo principal
5. Marcador radiopaco de oro
1. Jambages iliaques
2. Marqueurs radio-opaques en or (4)
3. Stent suprarénal
4. Corps principal
5. Marqueur radio-opaque en or
1. Iliacaszárak
2. Arany sugárfogó markerek (4)
3. Suprarenalis sztent
4. Fő grafttörzs
5. Arany sugárfogó marker
1. Branche iliache
2. Marker radiopachi in oro (4)
3. Stent soprarenale
4. Corpo principale
5. Marker radiopaco in oro
1. Iliacale poten
2. Gouden radiopake markeringen (4)
3. Suprarenale stent
4. Main body
5. Gouden radiopake markering
1. Iliaca-ben
2. Radioopake gullmarkører (4)
3. Suprarenal stent
4. Hoveddel
5. Radioopak gullmarkør
1. Odnogi biodrowe
2. Złote znaczniki cieniodajne (4)
3. Stent nadnerkowy
4. Główny trzon
5. Złoty znacznik cieniodajny
1. Extremidades ilíacas
2. Marcador radiopaco de ouro (4)
3. Stent supra-renal
4. Corpo principal
5. Marcador radiopaco de ouro
1. Iliakaliska graftben
2. Röntgentäta guldmarkeringar (4)
3. Suprarenal stent
4. Huvudstomme
5. Röntgentät markering av guld
1
23
54
Fig. 1
5
Illustrations • Ilustrace • Illustrationer • Abbildungen • Απεικονίσεις • Ilustraciones • Illustrations • Illusztrációk • Illustrazioni • Afbeeldingen • Illustrasjoner • Ilustracje • Ilustrações • Illustrationer
12
1. Hub
2. Pin Vise
3. Gripper
4. Peel-Away® Sheath
5. Stopcock
6. Connecting Tube
7. Flexor® Introducer Sheath
8. Dilator Tip
9. Flushing Groove
10. Captor® Hemostatic Valve
11. Gray Positioner
12. Inner Cannula
13. Iliac Leg Graft
1. Ústí
2. Svěrka
3. Držák
4. Sheath Peel-Away®
5. Uzavírací kohout
6. Spojovací hadička
7. Zaváděcí sheath Flexor®
8. Hrot dilatátoru
9. Proplachovací zářez
10. Hemostatický ventil Captor®
11. Šedý polohovač
12. Vnitřní kanyla
13. Iliakální rameno graftu
1. Muffe
2. Pin vise
3. Gribeanordning
4. Peel-Away® sheath
5. Hane
6. Tilslutningsslange
7. Flexor® indføringssheath
8. Dilatatorspids
9. Skyllerille
10. Captor® hæmostatisk ventil
11. Grå positioneringsanordning
12. Indre kanyle
13. Iliaca-ben
1. Ansatz
2. Klemmschraube
3. Greifer
4. Peel-Away®-Schleuse
5. Absperrhahn
6. Verbindungsschlauch
7. Flexor®-Einführschleuse
8. Dilatatorspitze
9. Spülrille
10. Captor®-Hämostaseventil
11. Grauer Positionierer
12. Innere Kanüle
13. Iliakaler Prothesenschenkel
1. Ομφαλός
2. Μέγγενη ακίδας
3. Συσκευή σύλληψης
4. Θηκάρι Peel-Away®
5. Στρόφιγγα
6. Συνδετικός σωλήνας
7. Θηκάρι εισαγωγής Flexor®
8. Άκρο διαστολέα
9. Εγκοπή έκπλυσης
10. Αιμοστατική βαλβίδα Captor®
11. Γκρι διάταξη τοποθέτησης
12. Εσωτερική κάνουλα
13. Μόσχευμα λαγόνιου σκέλους
1. Conector
2. Manguito
3. Agarrador
4. Vaina Peel-Away®
5. Llave de paso
6. Tubo conector
7. Vaina introductora Flexor®
8. Punta del dilatador
9. Ranura de lavado
10. Válvula hemostática Captor®
11. Posicionador gris
12. Cánula interior
13. Rama ilíaca de la endoprótesis vascular
1. Embase
2. Vis à broche
3. Repose-doigt
4. Gaine Peel-Away®
5. Robinet
6. Tube connecteur
7. Gaine d’introduction Flexor®
8. Extrémité du dilatateur
9. Orifice latéral de purge
10. Valve hémostatique Captor®
11. Positionneur gris
12. Canule interne
13. Jambage iliaque
1. Kónusz
2. Rögzítőelem
3. Markoló
4. Peel-Away® hüvely
5. Elzárócsap
6. Összekötőcső
7. Flexor® bevezetőhüvely
8. Dilatátor csúcsa
9. Öblítőhorony
10. Captor® vérzéscsillapító szelep
11. Szürke pozicionáló
12. Belső kanül
13. Iliacaszár graft
1. Connettore
2. Morsetto
3. Elemento di presa
4. Guaina Peel-Away®
5. Rubinetto
6. Tubo connettore
7. Guaina di introduzione Flexor®
8. Punta del dilatatore
9. Incavo di lavaggio
10. Valvola emostatica Captor®
11. Posizionatore grigio
12. Cannula interna
13. Branca iliaca della protesi
1. Aanzetstuk
2. Borgschroef
3. Grijper
4. Peel-Away® sheath
5. Afsluitkraan
6. Verbindingsslang
7. Flexor® introducer sheath
8. Dilatatortip
9. Spoelgroef
10. Captor® hemostaseklep
11. Grijze pusher
12. Binnencanule
13. Iliacale poot
1. Kanylefeste
2. Klemmeskrue
3. Gripestykke
4. Peel-Away® hylse
5. Stoppekran
6. Tilkoblingsslange
7. Flexor® innføringshylse
8. Dilatatorspiss
9. Skyllerenne
10. Captor® hemostaseventil
11. Grå posisjoneringsenhet
12. Indre kanyle
13. Iliaca-benimplantat
1. Złączka
2. Imadło sztyftowe
3. Chwytak
4. Koszulka Peel-Away®
5. Kranik odcinający
6. Rurka łącząca
7. Koszulka wprowadzająca Flexor®
8. Końcówka rozszerzacza
9. Rowek do przepłukiwania
10. Zastawka hemostatyczna Captor®
11. Szary pozycjoner
12. Kaniula wewnętrzna
13. Stent-graft odnogi biodrowej
1. Conector
2. Pino de fixação
3. Zona de preensão
4. Bainha Peel-Away®
5. Torneira de passagem
6. Tubo de ligação
7. Bainha introdutora Flexor®
8. Ponta dilatadora
9. Canal de irrigação
10. Válvula hemostática Captor®
11. Posicionador cinzento
12. Cânula interior
13. Extremidade ilíaca da prótese
1. Fattning
2. Skruvstycke
3. Gripare
4. Peel-Away®-hylsa
5. Infusionskran
6. Kopplingsslang
7. Flexor® införarhylsa
8. Dilatatorspets
9. Spolningsskåra
10. Captor® hemostasventil
11. Grå lägeställare
12. Inre kanyl
13. Iliakaliskt graftben
1 2
11
3
5
6
78
9
Fig. 2
10
12
13
4
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13
Fig. 4
Fig. 5
Fig. 6
Fig. 3
Illustrations • Ilustrace • Illustrationer • Abbildungen • Απεικονίσεις • Ilustraciones • Illustrations • Illusztrációk • Illustrazioni • Afbeeldingen • Illustrasjoner • Ilustracje • Ilustrações • Illustrationer
14
Fig. 7 Fig. 8
Fig. 10
Fig. 11
Fig. 9
Illustrations • Ilustrace • Illustrationer • Abbildungen • Απεικονίσεις • Ilustraciones • Illustrations • Illusztrációk • Illustrazioni • Afbeeldingen • Illustrasjoner • Ilustracje • Ilustrações • Illustrationer
15
Fig. 12 Fig. 13
Fig. 14
1. Balloon Expansion/Graft Sealing Sites
1. Expanze balónku/místa utěsnění graftu
1. Ballonekspansion/proteseforseglingssteder
1. Ballonaufweitungs- / Prothesendichtungsstellen
1. Θέσεις διαστολής μπαλονιού/στεγανοποίησης
μοσχεύματος
1. Lugares de hinchado del balón y sellado de
la endoprótesis vascular
1. Sites de gonflage du ballonnet et d’étanchéité
de l’endoprothèse
1. Ballon feltöltés/graft tapadási helyei
1. Siti di dilatazione del palloncino/fissaggio
dell’endoprotesi
1. Plaatsen voor ballonexpansie/protheseafdichting
1. Ballongekspansjons-/implantatforseglingssteder
1. Miejsca rozprężania balonu/uszczelniania
stent-graftu
1. Locais de expansão do balão/selagem da prótese
1. Ballongexpansion/graftets tätningsställen
1
16
ENGLISH
ZENITH® SPIRALZ AAA ILIAC LEG WITH THE
ZTRAK™ INTRODUCTION SYSTEM
Suggested Instructions for Use
Read all instructions carefully. Failure to properly follow the instructions,
warnings and precautions may lead to serious surgical consequences or
injury to the patient.
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the
order of a physician.
CAUTION: All contents of the outer pouch (including the introduction
system and endovascular grafts) are supplied sterile, for single use only.
For the Zenith product line there are seven applicable Suggested Instructions
for Use (IFU). This IFU describes the Suggested Instructions for Use for the
Zenith Spiral-Z AAA Iliac Leg. For information on other applicable Zenith
components, please refer to the following Instructions for Use:
•ZenithAAAEndovascularGraft(ZenithAAAEndovascularGraftmainbody);
•ZenithFlex®AAAEndovascularGraftMainBodyComponent;
•ZenithRenu®AAAAncillaryGraft(mainbodyextensionandconverter
configurations);
•ZenithFenestratedAAAEndovascularGraft;
•ZenithBranchIliacEndovascularGraft;
•ZenithAAAEndovascularGraftAncillaryComponents(ZenithAAA
Endovascular Graft main body extensions, iliac leg extensions, converters
andiliacplugs);and
•Coda®BalloonCatheter.
1 DEVICE DESCRIPTION
1.1 Zenith Spiral-Z AAA Iliac Leg
The Zenith Spiral-Z AAA Iliac Leg should be used in conjunction with the
Zenith AAA main bodies (Flex, Fenestrated, and Branch) or Renu and is a part
of a modular system consisting of multiple components, most typically a
bifurcated main body and two iliac legs. (Fig. 1) The iliac legs are constructed
of full-thickness woven polyester fabric sewn to two self-expanding stainless
steel Cook-Z® stents and a continuous nitinol spiral stent with braided
polyester and monofilament polypropylene suture. The graft is fully stented
to provide stability and the expansile force necessary to open the lumen of
the graft during deployment. Additionally, the Cook-Z stents placed at the
ends of the graft provide the necessary attachment and seal of the graft to
the vessel wall.
1.2 Delivery System
The Zenith Spiral-Z AAA Iliac Leg is shipped pre-loaded onto a 14 French or
16 French Z-Trak Introduction System. (Fig. 2) The delivery system is designed
for ease of use with minimal preparation. All systems are compatible with a
.035 inch wire guide.
For added hemostasis, the Captor™ Hemostatic Valve can be loosened or
tightened for the introduction and/or removal of ancillary devices into
and out of the sheath. In addition, the delivery system features a Flexor®
introducer sheath which resists kinking and is hydrophilically coated.
Both features are intended to enhance trackability in the iliac arteries and
abdominal aorta.
2 INDICATIONS FOR USE
The Zenith Spiral-Z AAA Iliac Leg with the Z-Trak Introduction System is
indicated for use with the Zenith AAA Endovascular Graft family of products,
including the Zenith Flex AAA Endovascular Graft, Zenith Renu Ancillary
Graft, Zenith Fenestrated AAA Endovascular Graft, or Zenith Branch Iliac
Endovascular Graft, during either a primary or a secondary procedure
in patients who have adequate iliac/femoral access compatible with the
required introduction systems. The graft is used in combination with these
products for the endovascular treatment of abdominal aortic and aorto-iliac
aneurysms.
3 CONTRAINDICATIONS
The Zenith Spiral-Z AAA Iliac Leg with the Z-Trak Introduction System is
contraindicated in:
•Patientswithknownsensitivitiesorallergiestostainlesssteel,polyester,
solder (tin, silver), polypropylene, nitinol, or gold.
•Patientswithasystemicorlocalinfectionthatmayincreasetheriskof
endovascular graft infection.
4 WARNINGS AND PRECAUTIONS
4.1 General
•Readallinstructionscarefully.Failuretoproperlyfollowtheinstructions,
warnings and precautions may lead to serious consequences or injury to
the patient.
•Alwayshaveaqualifiedsurgeryteamavailableduringimplantationor
reintervention procedures in the event that conversion to open surgical
repair is necessary.
•TheZenithSpiral-ZAAAIliacLegwiththeZ-TrakIntroductionSystem
should only be used by physicians and teams trained in vascular
interventional techniques (catheter-based and surgical) and in the use of
this device. Specific training expectations are described in Section 10.1,
Physician Training.
•Additionalendovascularinterventionsorconversiontostandardopen
surgical repair following initial endovascular repair should be considered
for patients experiencing enlarging aneurysms, unacceptable decrease
in fixation length (vessel and component overlap) and/or endoleak. An
increase in aneurysm size and/or persistent endoleak or migration may
lead to aneurysm rupture.
•Patientsexperiencingreducedbloodflowthroughthegraftlimband/
or leaks may be required to undergo secondary interventions or surgical
procedures.
4.2 Patient Selection, Treatment and Follow-Up
•ZenithSpiral-Ziliacarterydistalfixationsitegreaterthan10mmin
length and 7.5-20 mm in diameter (measured outer wall to outer wall) is
required. These sizing measurements are critical to the performance of
the endovascular repair.
•Forsizingrequirementsandalistofkeyanatomicalelementsthatmay
affect successful aneurysm exclusion using a Main Body or Renu from the
Zenith AAA Endovascular Graft family of products, refer to the appropriate
Instructions for Use.
•Adequateiliacorfemoralaccessisrequiredtointroducethedeviceinto
the vasculature. Access vessel diameter (measured inner wall to inner
wall) and morphology (minimal tortuosity, occlusive disease and/or
calcification) should be compatible with vascular access techniques and
delivery systems of a 14 French to 16 French vascular introducer sheath.
Vessels that are significantly calcified, occlusive, tortuous or thrombus-
lined may preclude placement of the endovascular graft and/or may
increase the risk of embolization. A vascular conduit technique may be
necessary to achieve success in some patients.
•TheZenithSpiral-ZAAAIliacLegwiththeZ-TrakIntroductionSystem
is not recommended in patients who cannot tolerate contrast agents
necessary for intra-operative and postoperative follow-up imaging.
All patients should be monitored closely and checked periodically
for a change in the condition of their disease and the integrity of the
endoprosthesis.
•TheZenithSpiral-ZAAAIliacLegwiththeZ-TrakIntroductionSystemis
not recommended in patients exceeding weight and/or size limits which
compromise or prevent the necessary imaging requirements.
•Inabilitytomaintainpatencyofatleastoneinternaliliacarteryor
occlusion of an indispensible inferior mesenteric artery may increase the
risk of pelvic/bowel ischemia.
•Multiplelarge,patentlumbararteries,muralthrombusandapatent
inferior mesenteric artery may all predispose a patient to Type II
endoleaks. Patients with uncorrectable coagulopathy may also have an
increased risk of Type II endoleak or bleeding complications.
•TheZenithSpiral-ZAAAIliacLeghasnotbeenexplicitlyevaluated
clinically;however,itsperformanceisrepresentedbytheZenithAAA
Endovascular Graft Iliac Leg (a previous version of the device), which has
not been evaluated in the following patient populations:
• traumaticaorticinjury
• leaking,pendingruptureorrupturedaneurysms
• mycoticaneurysms
• pseudoaneurysmsresultingfrompreviousgraftplacement
• revisionofpreviouslyplacedendovasculargrafts
• uncorrectablecoagulopathy
• indispensiblemesentericartery
• geneticconnectivetissuedisease(e.g.,MarfansorEhlers-Danlos
Syndromes)
• concomitantthoracicaorticorthoracoabdominalaneurysms
• patientswithactivesystemicinfections
• pregnantornursingfemales
• morbidlyobesepatients
• lessthan18yearsofage
• keyanatomicalelementsthatfalloutsidethesizingrequirements
specified in the appropriate main body or Renu Instructions for Use.
•Successfulpatientselectionrequiresspecificimagingandaccurate
measurements;pleaseseeSection 4.3, Pre-Procedure Measurement
Techniques and Imaging.
•Alllengthsanddiametersofthedevicesnecessarytocompletethe
procedure should be available to the physician, especially when pre-
operative case planning measurements (treatment diameters/lengths) are
not certain. This approach allows for greater intra-operative flexibility to
achieve optimal procedural outcomes.
4.3 Pre-Procedure Measurement Techniques and Imaging
•Lackofnon-contrastCTimagingmayresultinfailuretoappreciateiliacor
aortic calcification, which may preclude access or reliable device fixation
and seal.
•Pre-procedureimagingreconstructionthicknesses>3mmmayresultin
sub-optimal device sizing, or in failure to appreciate focal stenoses from
CT.
•Clinicalexperienceindicatesthatcontrast-enhancedspiralcomputed
tomographic angiography (CTA) with 3-D reconstruction is the strongly
recommended imaging modality to accurately assess patient anatomy
prior to treatment with the Zenith Spiral-Z AAA Iliac Leg. If contrast-
enhanced spiral CTA with 3-D reconstruction is not available, the patient
should be referred to a facility with these capabilities.
•Cliniciansrecommendthatangiographyshoulddemonstratetheiliac
artery bifurcations such that the distal common iliacs are well defined
relative to the origin of the internal iliac arteries bilaterally, prior to
deployment of the iliac leg components.
Diameters
Utilizing CT, diameter measurements should be determined from the outer
wall to outer wall vessel diameter (not lumen measurement) to help with
proper device sizing and device selection. The contrast-enhanced spiral CT
scan must start 1 cm superior to the celiac axis and continue through the
femoral heads at an axial thickness slice of 3 mm or less.
Lengths
Utilizing CT, length measurements should be determined to accurately
assess length as well as planning Zenith Spiral-Z AAA Iliac Leg components.
These reconstructions should be performed in sagittal, coronal, and 3-D.
•Allpatientsshouldbeadvisedthatendovasculartreatmentrequires
life-long, regular follow-up to assess their health and the performance
of their endovascular graft. Patients with specific clinical findings (e.g.,
endoleaks, enlarging aneurysm or changes in the structure or position
of the endovascular graft) should receive enhanced follow-up. Specific
follow-up guidelines are described in Section 12, IMAGING GUIDELINES
AND POSTOPERATIVE FOLLOWUP.
•TheZenithSpiral-ZAAAIliacLegwiththeZ-TrakIntroductionSystem
is not recommended in patients unable to undergo, or who will not
be compliant with, the necessary preoperative and postoperative
imaging and implantation studies as described in Section 12, IMAGING
GUIDELINES AND POSTOPERATIVE FOLLOWUP.
•Afterendovasculargraftplacement,patientsshouldberegularly
monitored for perigraft flow, aneurysm growth or changes in the
structure or position of the endovascular graft. At a minimum, annual
imaging is required, including: 1) abdominal radiographs to examine
device integrity (separation between components or stent fracture) and
2) contrast and non-contrast CT to examine aneurysm changes, perigraft
flow, patency, tortuosity and progressive disease. If renal complications
or other factors preclude the use of image contrast media, abdominal
radiographs and duplex ultrasound may provide similar information.
4.4 Device Selection
•StrictadherencetotheZenithSpiral-ZAAAIliacLegIFUsizingguideis
17
strongly recommended when selecting the appropriate device size (Table
10.5.1). Appropriate device oversizing has been incorporated into the IFU
sizing guide. Sizing outside of this range can result in endoleak, fracture,
migration, device infolding or compression.
4.5 Implant Procedure
(Refer to Section 11, DIRECTIONS FOR USE)
•Appropriateproceduralimagingisrequiredtosuccessfullypositionthe
Zenith Spiral-Z AAA Iliac Leg and assure accurate apposition to the vessel
wall.
•Donotbendorkinkthedeliverysystem.Doingsomaycausedamageto
the delivery system and the Zenith Spiral-Z AAA Iliac Leg Graft.
•Toavoidanytwistintheendovasculargraft,duringanyrotationof
the delivery system, be careful to rotate all components of the system
together (from outer sheath to inner cannula).
•Donotcontinueadvancinganyportionofthedeliverysystemif
resistance is felt during advancement of the wire guide or delivery system.
Stopandassessthecauseofresistance;vessel,catheterorgraftdamage
may occur. Exercise particular care in areas of stenosis, intravascular
thrombosis, or in calcified or tortuous vessels.
•Inadvertentpartialdeploymentormigrationoftheendoprosthesismay
require surgical removal.
•Unlessmedicallyindicated,donotdeploytheZenithSpiral-ZAAAIliac
Leg in a location that will occlude arteries necessary to supply blood flow
to organs or extremities.
•Donotattempttore-sheaththegraftafterpartialorcomplete
deployment.
•Inaccurateplacementand/orincompletesealingoftheZenithSpiral-Z
AAA Iliac Leg within the vessel may result in increased risk of endoleak,
migration or inadvertent occlusion of the internal iliac arteries.
•InadequateoverlapoftheZenithSpiral-ZAAAIliacLegmayresultin
increased risk of migration of the stent graft. Incorrect deployment or
migration of the endoprosthesis may require surgical intervention.
•Systemicanticoagulationshouldbeusedduringtheimplantprocedure
based on hospital- and physician-preferred protocol. If heparin is
contraindicated, an alternative anticoagulant should be considered.
•ToactivatethehydrophiliccoatingontheoutsideoftheFlexor
introducer sheath, the surface must be wiped with sterile gauze pads
soaked in saline solution. Always keep the sheath hydrated for optimal
performance.
•Minimizehandlingoftheconstrainedendoprosthesisduringpreparation
and insertion to decrease the risk of endoprosthesis contamination and
infection.
•Maintainwireguidepositionduringdeliverysysteminsertion.
•Fluoroscopyshouldbeusedduringintroductionanddeploymentto
confirm proper operation of the delivery system components, proper
placement of the graft, and desired procedural outcome.
•TheuseoftheZenithSpiral-ZAAAIliacLegwiththeZ-TrakIntroduction
System requires administration of intravascular contrast. Patients with
pre-existing renal insufficiency may have an increased risk of renal failure
postoperatively. Care should be taken to limit the amount of contrast
media used during the procedure and to observe preventative methods
of treatment to decrease renal compromise (e.g., adequate hydration).
•Asthesheathand/orwireguideiswithdrawn,anatomyandgraftposition
may change. Constantly monitor graft position and perform angiography
to check position as necessary.
•Usecautionduringmanipulationofcatheters,wiresandsheaths
within an aneurysm. Significant disturbances may dislodge fragments
of thrombus, which can cause distal embolization, or may rupture the
aneurysm.
•Avoiddamagingthegraftordisturbinggraftpositioningafterplacement
in the event reinstrumentation (secondary intervention) of the graft is
necessary.
•Verifythatthepredeterminedcontralateraliliaclegisselectedfor
insertion on the contralateral side of the patient before implantation.
4.6 Molding Balloon Use
•Donotinflatetheballooninthevesseloutsideofthegraft,asdoingso
may cause damage to the vessel. Use the balloon in accordance with its
labeling.
•Usecareininflatingtheballoonwithinthegraftinthepresenceof
calcification, as excessive inflation may cause damage to the vessel.
•Confirmcompletedeflationoftheballoonpriortorepositioning.
•Foraddedhemostasis,theCaptorHemostaticValvecanbeloosenedor
tightened to accommodate the insertion and subsequent withdrawal of a
molding balloon.
4.7 MRI Information
Non-clinical testing has demonstrated that the Zenith Spiral-Z AAA Iliac
Leg Graft is MR Conditional. It can be scanned safely immediately after
placement under the following conditions:
Static Magnetic Field
•Staticmagneticfieldof3.0Teslaorless.
•Highestspatialmagneticgradientfieldof720Gauss/cm
Non-clinical evaluation was conducted in a 3 Tesla MR system (General
Electric Excite) with a maximum spatial magnetic gradient field of
720 Gauss/cm as measured with a gaussmeter in the position of the static
magnetic field pertinent to the patient (i.e., outside of scanner covering,
accessible to a patient or individual).
MRI-Related Heating
1.5 Tesla Systems:
•Staticmagneticfieldof1.5Tesla
•Maximumwhole-body-averagedspecificabsorptionrate(SAR)of2W/kg
for 15 minutes of scanning ( i.e., per scanning sequence)
In non-clinical testing, the Zenith Spiral-Z AAA Iliac Leg produced a
temperature rise of less than or equal to 2.1 °C at a maximum whole-body-
averaged specific absorption rate (SAR) of 2.9 W/kg, for 15 minutes of MR
scanning in a 1.5 Tesla, Siemens Medical Magnetom, Numaris/4 Software,
Version Syngo MR 2002B DHHS MR Scanner. The maximum whole-body-
averaged specific absorption rate (SAR) was 2.9 W/kg, which corresponds to
a calorimetry measured value of 2.1 W/kg.
3.0 Tesla Systems:
•Staticmagneticfieldof3.0Tesla
•Maximumwhole-body-averagedspecificabsorptionrate(SAR)of2W/kg
for 15 minutes of scanning( i.e., per scanning sequence)
In non-clinical testing, the Zenith Spiral-Z AAA Iliac Leg produced a
temperature rise of less than or equal to 2.6 °C at a maximum whole-body-
averaged specific absorption rate (SAR) of 2.9 W/kg, for 15 minutes of MR
scanning in a 3.0 Tesla Excite, GE Electric Healthcare, 14X.M5 Software,
MR Scanner. The maximum whole-body-averaged specific absorption rate
(SAR) was 2.9 W/kg, which corresponds to a calorimetry measured value of
2.7 W/kg.
Image Artifact
The image artifact extends throughout the anatomical region containing the
device, obscuring the view of immediately adjacent anatomical structures
within approximately 5 cm of the device, as well as the entire device and its
lumen, when scanned in nonclinical testing using the sequence: Fast spin
echo, in a 3.0 Tesla, Excite, GE Electric Healthcare, with G3.0-052B Software,
MR system with body radiofrequency coil.
For all scanners, the image artifact dissipates as the distance from the device
to the area of interest increases. MR scans of the head and neck and lower
extremities may be obtained without image artifact. Image artifact may be
present in scans of the abdominal region, depending on distance from the
device to the area of interest.
Cook recommends that the patient register the MR conditions disclosed in
this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be
contacted in the following manners.
Mail: MedicAlert Foundation International
2323 Colorado Avenue
Turlock, CA 95382
Phone: 888-633-4298 (toll free)
209-668-3333 from outside the US
Fax: 209-669-2450
Web: www.medicalert.org
5 ADVERSE EVENTS
5.1 Observed Adverse Events
For information on observed adverse events in patients receiving Zenith
AAA Endovascular Grafts, please refer to the appropriate IFU from the Zenith
AAA Endovascular Graft family of products. A copy is available online at
www.cookmedical.com.
5.2 Potential Adverse Events
Adverse events that may occur and/or require intervention include, but are
not limited to:
•Amputation
•Anestheticcomplicationsandsubsequentattendantproblems(e.g.,
aspiration)
•Aneurysmenlargement
•Aneurysmruptureanddeath
•Aorticdamage,includingperforation,dissection,bleeding,ruptureand
death
•Arterialorvenousthrombosisand/orpseudoaneurysm
•Arteriovenousfistula
•Bleeding,hematomaorcoagulopathy
•Bowelcomplications(e.g.,ileus,transientischemia,infarction,necrosis)
•Cardiaccomplicationsandsubsequentattendantproblems(e.g.,
arrhythmia, myocardial infarction, congestive heart failure, hypotension,
hypertension)
•Claudication(e.g.,buttock,lowerlimb)
•Death
•Edema
•Embolization(microandmacro)withtransientorpermanentischemiaor
infarction
•Endoleak
•Endoprosthesis:impropercomponentplacement;incompletecomponent
deployment;componentmigration;componentseparationfromanother
graftcomponent;suturebreak;occlusion;infection;stentfracture;graft
materialwear;dilatation;erosion;puncture;perigraftflow;andcorrosion
•Feverandlocalizedinflammation
•Genitourinarycomplicationsandsubsequentattendantproblems(e.g.,
ischemia, erosion, fistula, incontinence, hematuria, infection)
•Graftornativevesselocclusion
•Hepaticfailure
•Impotence
•Infectionoftheaneurysm,deviceoraccesssite,includingabscess
formation, transient fever and pain
•Lymphaticcomplicationsandsubsequentattendantproblems(e.g.,
lymph fistula)
•Neurologiclocalorsystemiccomplicationsandsubsequentattendant
problems (e.g., stroke, transient ischemic attack, paraplegia, paraparesis,
paralysis)
•Pulmonary/respiratorycomplicationsandsubsequentattendant
problems (e.g., pneumonia, respiratory failure, prolonged intubation)
•Renalcomplicationsandsubsequentattendantproblems(e.g.,artery
occlusion, contrast toxicity, insufficiency, failure)
•Surgicalconversiontoopenrepair
•Vascularaccesssitecomplications,includinginfection,pain,hematoma,
pseudoaneurysm, arteriovenous fistula
•Vesseldamage
•Woundcomplicationsandsubsequentattendantproblems(e.g.,
dehiscence, infection)
•Vascularspasmorvasculartrauma(e.g.,iliofemoralvesseldissection,
bleeding, rupture, death)
Device-Related Adverse Event Reporting
Any adverse event (clinical incident) involving the Zenith Spiral-Z AAA Iliac
Leg should be reported to Cook immediately. For customers inside the
United States, to report an incident, call the Customer Relations Department
at 1-800-457-4500 (24 hour) or 1-812-339-2235. For customers outside the
United States, please call your distributor.
6 SUMMARY OF CLINICAL STUDIES
For clinical study information regarding patients receiving Zenith AAA
18
Endovascular Grafts, please refer to the appropriate IFU from the Zenith AAA
Endovascular Graft family of products. A copy is available online at
www.cookmedical.com.
7 PATIENT SELECTION AND TREATMENT
(See Section 4, WARNINGS AND PRECAUTIONS)
7.1 Individualization of Treatment
Cook recommends that the Zenith Spiral-Z AAA Iliac Leg diameters be
selected as described in Table 10.5.1. All lengths and diameters of the
devices necessary to complete the procedure should be available to the
physician, especially when preoperative case planning measurements
(treatment diameters/lengths) are not certain. This approach allows for
greater intra-operative flexibility to achieve optimal procedural outcomes.
The risks and benefits should be carefully considered for each patient before
use of the Zenith Spiral-Z AAA Iliac Leg. Additional considerations for patient
selection include, but are not limited to:
•Patient’sageandlifeexpectancy
•Co-morbidities(e.g.,cardiac,pulmonaryorrenalinsufficiencypriorto
surgery, morbid obesity)
•Patient’ssuitabilityforopensurgicalrepair
•Patient’sanatomicalsuitabilityforendovascularrepair
•Theriskofaneurysmrupturecomparedtotheriskoftreatmentwiththe
Zenith Spiral-Z AAA Iliac Leg
•Patient’sabilitytotolerategeneral,regionalorlocalanesthesia
•Iliofemoralaccessvesselsizeandmorphology(minimalthrombus,
calcification and/or tortuosity) should be compatible with vascular access
techniques and accessories of the delivery profile of a 14 French to
16 French vascular introducer sheath
•ZenithSpiral-Ziliacarterydistalfixationsitegreaterthan10mminlength
and 7.5-20 mm in diameter (measured outer wall to outer wall)
•Freedomfromsignificantfemoral/iliacarteryocclusivediseasethatwould
impede flow through the endovascular graft
The final treatment decision is at the discretion of the physician and patient.
8 PATIENT COUNSELING INFORMATION
The physician and patient (and/or family members) should review the risks
and benefits when discussing this endovascular device and procedure,
including:
•Risksanddifferencesbetweenendovascularrepairandsurgicalrepair
•Potentialadvantagesoftraditionalopensurgicalrepair
•Potentialadvantagesofendovascularrepair
•Thepossibilitythatsubsequentinterventionaloropensurgicalrepairof
the aneurysm may be required after initial endovascular repair
In addition to the risks and benefits of an endovascular repair, the physician
should assess the patient’s commitment and compliance to postoperative
follow-up as necessary to ensure continuing safe and effective results. Listed
below are additional topics to discuss with the patient as to expectations
after an endovascular repair:
•Allpatientsshouldbeadvisedthatendovasculartreatmentrequireslife-
long, regular follow-up to assess their health and the performance of their
endovascular graft. Patients with specific clinical findings (e.g., endoleaks,
enlarging aneurysms or changes in the structure or position of the
endovascular graft) should receive enhanced follow-up. Specific follow-up
guidelines are described in Section 12, IMAGING GUIDELINES AND
POSTOPERATIVE FOLLOWUP.
•Patientsshouldbecounseledontheimportanceofadheringtothe
follow-up schedule, both during the first year and at yearly intervals
thereafter. Patients should be told that regular and consistent follow-
up is a critical part of ensuring the ongoing safety and effectiveness of
endovascular treatment of AAAs. At a minimum, annual imaging and
adherence to routine postoperative follow-up requirements is required
and should be considered a life-long commitment to the patient’s health
and well-being.
•Physiciansmustadviseallpatientsthatitisimportanttoseekprompt
medical attention if they experience signs of limb occlusion, aneurysm
enlargement or rupture. Signs of graft limb occlusion include pain in the
hip(s) or leg(s) during walking or at rest or discoloration or coolness of
the leg. Aneurysm rupture may be asymptomatic, but usually presents
as:pain;numbness;weaknessinthelegs;anyback,chest,abdominalor
groinpain;dizziness;fainting;rapidheartbeatorsuddenweakness.
•Duetotheimagingrequiredforsuccessfulplacementandfollow-upof
endovascular devices, the risks of radiation exposure to developing tissue
should be discussed with women who are or suspect they are pregnant.
Men who undergo endovascular or open surgical repair may experience
impotence.
Physicians should refer patients to the Patient Guide regarding risks
occurring during or after implantation of the device. Procedure-related risks
include cardiac, pulmonary, neurologic, bowel and bleeding complications.
Device-related risks include occlusion, endoleak, aneurysm enlargement,
fracture, potential for reintervention and open surgical conversion, rupture
and death (See Section 5.1, Observed Adverse Events and Section 5.2,
Potential Adverse Events). The physician should complete the Patient I.D.
Card and give it to the patient so that he/she can carry it with him/her at all
times. The patient should refer to the card anytime he/she visits additional
health practitioners, particularly for any additional diagnostic procedures
(e.g., MRI).
9 HOW SUPPLIED
•TheZenithSpiral-ZAAAIliacLegsaresterilizedbyethyleneoxidegas,are
pre-loaded into the Z-Trak Introduction System, and are supplied in peel-
open packages.
•Thedevicesareintendedforsingleuseonly.Donotre-sterilizethe
devices.
•Theproductissterileifthepackageisunopenedandundamaged.
Inspect the device and packaging to verify that no damage has occurred
as a result of shipping. Do not use this device if damage has occurred or
if the sterilization barrier has been damaged or broken. If damage has
occurred, do not use the product and return to Cook.
•Priortouse,verifycorrectdevices(quantityandsize)havebeensupplied
for the patient by matching the device to the order prescribed by the
physician for that particular patient.
•TheZenithSpiral-ZAAAIliacLegisloadedontoa14or16FrenchFlexor
introducer sheath. The sheath’s surface is treated with a hydrophilic
coating that, when hydrated, enhances trackability. To activate the
hydrophilic coating, the surface must be wiped with a sterile gauze pad
soaked in saline solution under sterile conditions.
•Donotuseafterthe“USEBY”(expiration)dateprintedonthelabel.
•Storeinacool,dryplace.
10 CLINICAL USE INFORMATION
10.1 Physician Training
CAUTION: Always have a vascular surgery team available during
implantation or re-intervention procedures in the event that conversion
to open surgical repair is necessary.
CAUTION: The Zenith Spiral-Z AAA Iliac Leg with the Z-Trak Introduction
System should only be used by physicians and teams trained in
vascular interventional techniques and in the use of this device. The
recommended skill/knowledge requirements for physicians using the
Zenith Spiral-Z AAA Iliac Leg with the Z-Trak Introduction System are
outlined below.
Patient selection:
•Knowledgeofthenaturalhistoryofabdominalaorticaneurysms(AAA)
and co-morbidities associated with AAA repair.
•Knowledgeofradiographicimageinterpretation,deviceselection,
planning and sizing.
A multi-disciplinary team that has combined procedural experience
with:
•Femoralcutdown,arteriotomyandrepair
•Percutaneousaccessandclosuretechniques
•Non-selectiveandselectivewireguideandcathetertechniques
•Fluoroscopicandangiographicimageinterpretation
•Embolization
•Angioplasty
•Endovascularstentplacement
•Snaretechniques
•Appropriateuseofradiographiccontrastmaterial
•Techniquestominimizeradiationexposure
•Expertiseinnecessarypatientfollow-upmodalities
10.2 Inspection Prior to Use
Inspect the device and packaging to verify that no damage has occurred as
a result of shipping. Do not use this device if damage has occurred or if the
sterilization barrier has been damaged or broken. If damage has occurred, do
not use the product and return to Cook. Prior to use, verify correct devices
(quantity and size) have been supplied for the patient by matching the
device to the order prescribed by the physician for that particular patient.
10.3 Materials Required
•Fluoroscopewithdigitalangiographycapabilities(C-armorfixedunit)
•Contrastmedia
•Syringe
•Heparinizedsalinesolution
•Sterilegauzepads
10.4 Materials Recommended
The following products are recommended for implantation of any
component in the Zenith product line. For information on the use of these
products, refer to the individual product’s suggested instructions for use.
•.035inch(0.89mm)extrastiffwireguide,260cm;forexample:
• CookLunderquistExtraStiffWireGuides(LES)
•.035inch(0.89mm)standardwireguide;forexample:
• Cook.035inchwireguides
• CookNimble™WireGuides
•MoldingBalloons;forexample:
• CookCodaBalloonCatheter
•Introducersets;forexample:
• CookCheck-FloIntroducerSets
• CookExtraLargeCheck-FloIntroducerSets
• CookFlexorBalkinUp&OverContralateralIntroducers
•Sizingcatheter;forexample:
• CookAurousCentimeterSizingCatheters
•Angiographicradiopaquetipcatheters;forexample:
• CookBeaconTipAngiographicCatheters
• CookBeaconTipRoyalFlushCatheters
•Entryneedles;forexample:
• Cooksinglewallentryneedles
•EndovascularDilators;forexample:
• CookEndovascularDilatorSets
10.5 Device Diameter Sizing Guidelines
The choice of diameter should be determined from the outer wall to outer
wall vessel diameter and not the lumen diameter. Undersizing or oversizing
may result in incomplete sealing or compromised flow.
Table 10.5.1 Spiral-Z AAA Iliac Leg Graft Sizing Guide*
Intended
Iliac Vessel
Diameter 1,2
(mm)
Iliac Leg
Diameter3
(mm)
Iliac Leg Working
Length4(mm)
Introducer
Sheath (Fr)
≤8 9 39, 56, 74, 90, 107, 122 14
9 11 39, 56, 74, 90, 107, 122 14
10 - 12 13 39, 56, 74, 90, 107, 122 14
13 - 15 16 39, 56, 74, 90 14
16 - 18 20 39, 56, 74, 90 16
19 - 20 24 39, 56, 74, 90 16
1Maximum diameter along the proximal fixation site.
2Round measured aortic diameter to nearest mm.
3Additional considerations may affect choice of diameter.
4Overall leg length = working length + 22 mm docking stent.
*All dimensions are nominal.
19
11 DIRECTIONS FOR USE
Anatomical Requirements
•Iliofemoralaccessvesselsizeandmorphology(minimalthrombus,
calcium and/or tortuosity) should be compatible with vascular access
techniques and accessories. Arterial conduit techniques may be required.
•Foradditionalanatomicalrequirements,pleaserefertotheappropriate
main body or Renu IFU from the Zenith AAA Endovascular Graft family of
products. A copy is available online at www.cookmedical.com.
Prior to use of the Zenith Spiral-Z AAA Iliac Leg with the Z-Trak Introduction
System, review this Suggested Instructions for Use booklet. The following
instructions embody a basic guideline for device placement. Variations in the
following procedures may be necessary. These instructions are intended to
help guide the physician and do not take the place of physician judgment.
General Use Information
•Standardtechniquesforplacementofarterialaccesssheaths,guiding
catheters, angiographic catheters and wire guides should be employed
during use of the Zenith Spiral-Z AAA Iliac Leg with the Z-Trak
Introduction System. The Zenith Spiral-Z AAA Iliac Leg with the Z-Trak
Introduction System is compatible with .035 inch diameter wire guides.
•Endovascularstentgraftingisasurgicalprocedure,andbloodlossfrom
various causes may occur, infrequently requiring intervention (including
transfusion) to prevent adverse outcomes. It is important to monitor
blood loss from the hemostatic valve throughout the procedure, but is
specifically relevant during and after manipulation of the gray positioner.
After the gray positioner has been removed, if blood loss is excessive,
consider placing an uninflated molding balloon or an introduction system
dilator within the valve, restricting flow.
Pre-Implant Determinants
Verify from pre-implant planning that the correct device has been selected.
Determinants include:
1. Femoral artery selection for introduction of the delivery system (i.e.,
define respective contralateral and ipsilateral iliac arteries)
2. Angulation of aortic neck, aneurysm and iliac arteries
3. Diameters of infrarenal aortic neck and distal iliac arteries
4. Length from the aortic bifurcation of a previously placed main body or
Renu from the Zenith AAA Endovascular Graft family of products to the
internal iliac arteries/attachment site(s)
5. Aneurysm(s) extending into the iliac arteries may require special
consideration in selecting a suitable graft/artery interface site
6. Degree of vascular calcification
Patient Preparation
1. Refer to institutional protocols relating to anesthesia, anticoagulation
and monitoring of vital signs.
2. Position patient on imaging table allowing fluoroscopic visualization
from the aortic arch to the femoral bifurcations.
3. Expose selected common femoral artery using standard surgical
technique.
4. Establish adequate proximal and distal vascular control of selected
femoral vessel.
11.1 Zenith Spiral-Z AAA Iliac Leg System (Fig 2)
NOTE: For directions on how to place a main body or Renu from the Zenith
AAA Endovascular Graft family of products, refer to the Instructions for Use
included with the main body or Renu device.
11.1.1 Contralateral Iliac Leg Preparation/Flush
1. If applicable, remove gray-hubbed inner stylet (from the inner cannula)
and dilator tip protector (from the dilator tip). Remove Peel-Away
sheath from back of the hemostatic valve. (Fig. 3) Elevate distal tip of
system and flush through the stopcock on the hemostatic valve until
fluid emerges from the flushing groove near the tip of the introducer
sheath. (Fig. 4) Continue to inject a full 20 cc of flushing solution
through the device. Discontinue injection and close stopcock on the
connecting tube.
NOTE: Graft flushing solution of heparinized saline is often used.
2. Attach syringe with heparinized saline to the hub on the distal inner
cannula. Flush until fluid exits the distal dilator tip. (Fig. 5)
NOTE: When flushing system, elevate distal end of system to facilitate
removal of air.
3. Soak sterile gauze pads in saline solution and use to wipe Flexor
introducer sheath to activate the hydrophilic coating. Hydrate both
sheath and dilator liberally.
11.1.2 Ipsilateral Iliac Leg Preparation/Flush
Follow the instructions in the previous section, Contralateral Iliac Leg
Preparation/Flush, to ensure proper flushing of the ipsilateral iliac leg graft
and activation of the hydrophilic coating.
11.1.3 Vascular Access and Angiography
1. Puncture the selected common femoral arteries using standard
technique with an 18 or 19 UT gage arterial needle. Upon vessel entry,
insert:
• Wireguides–standard.035inchdiameter,145cmlong,Jtipor
Bentson Wire Guide
• Appropriatesizesheaths(e.g.,6or8French)
• Flushcatheter(oftenradiopaquesizingcatheters–e.g.,Centimeter
Sizing Catheter or straight flush catheter)
2. Perform angiography to identify level(s) of aortic bifurcation and iliac
bifurcations.
NOTE: If fluoroscope angulation is used with an angulated neck, it may
be necessary to perform angiograms using various projections.
NOTE: Technical assistance from a Cook product specialist may be
obtained by contacting your local Cook representative.
11.1.4 Contralateral Iliac Leg Placement and Deployment
1. Position the image intensifier to show both the contralateral internal
iliac artery and contralateral common iliac artery.
2. Prior to the introduction of the contralateral iliac leg delivery system,
inject contrast through the contralateral femoral sheath to locate the
contralateral internal iliac artery.
3. Introduce the contralateral iliac leg delivery system into the artery.
Advance slowly until the iliac leg graft overlaps at least one stent and
not past the radiopaque marker band positioned 30 mm from the
proximal end of the iliac leg graft inside the contralateral limb of the
main body. (Fig. 6) If there is any tendency for the main body graft to
move during this maneuver, hold it in position by stabilizing the gray
positioner on the ipsilateral side.
NOTE: A radiopaque marker band is positioned 30 mm from the proximal
end of the iliac leg graft to identify the maximum amount of overlap.
NOTE: If difficulty is encountered advancing the iliac leg delivery
system, exchange to a more supportive wire guide. In tortuous vessels
the anatomy may alter significantly with the introduction of the rigid
wires and sheath systems.
4. Confirm position of distal end of the iliac leg graft. Reposition the
iliac leg graft if necessary to ensure internal iliac patency, a minimum
overlap of one stent, and a maximum overlap of 30 mm within the
main body endovascular graft.
NOTE: Ensure the Captor Hemostatic Valve on the iliac leg introducer
sheath is turned to the open position. (Fig. 7)
5. To deploy, hold the iliac leg graft in position with the gripper on the
gray positioner while withdrawing the sheath. (Figs. 8 and 9) Ensure
overlap is maintained.
6. Stop withdrawing the sheath as soon as the distal end of the iliac leg
graft is released.
7. Under fluoroscopy and after verification of iliac leg graft position,
loosen pin vise and retract inner cannula to dock tapered dilator
to gray positioner. Tighten pin vise. Maintain sheath position while
withdrawing gray positioner with secured inner cannula.
8. Close the Captor Hemostatic Valve on the iliac leg introducer sheath by
turning it in a clockwise direction until it stops. (Fig. 10)
9. Re-check the position of the wire guide.
11.1.5 Ipsilateral Iliac Leg Placement and Deployment
NOTE: Ensure the Captor Hemostatic Valve on the main body introducer
sheath is turned to the open position. (Fig. 11)
1. Utilize the main body graft wire and sheath assembly to introduce the
ipsilateral iliac leg graft. Advance dilator and sheath assembly into the
main body sheath.
NOTE: In tortuous vessels, the position of the internal iliac arteries may
alter significantly with the introduction of the rigid wires and sheath
systems.
2. Advance slowly until the ipsilateral iliac leg graft overlaps a minimum
of one stent inside the ipsilateral limb of the main body. (Fig. 12)
NOTE: If an overlap of greater than 55 mm is required, it may be
necessary to consider use of a leg extension in the bifurcation area of
the opposite side.
NOTE: For use with Renu converter, ensure iliac leg overlaps a
minimum of one full iliac leg stent (i.e., proximal stent of iliac leg graft)
inside the Renu converter.
3. Confirm position of distal end of the iliac leg graft. Reposition the iliac
leg graft if necessary to ensure internal iliac patency.
NOTE: Ensure the Captor Hemostatic Valve on the iliac leg introducer
sheath is turned to the open position. (Fig. 7)
4. To deploy, stabilize the iliac leg graft with the gripper on the gray
positioner while withdrawing the iliac leg sheath. If necessary,
withdraw the main body sheath. (Figs. 8 and 13)
5. Under fluoroscopy and after verification of iliac leg graft position,
loosen pin vise, retract inner cannula to dock tapered dilator to gray
positioner. Tighten pin vise. Maintain main body sheath position while
withdrawing the iliac leg sheath and gray positioner with secured inner
cannula.
6. Close the Captor Hemostatic Valve on the main body introducer sheath
by turning it in a clockwise direction until it stops.
7. Re-check the position of the wire guides. Leave sheath and wire guide
in place.
11.1.6 Molding Balloon Insertion
1. Prepare molding balloon as follows:
• Flushwirelumenwithheparinizedsaline.
• Removeallairfromballoon.
2. In preparation for the insertion of the molding balloon, open the
Captor Hemostatic Valve by turning counter-clockwise. (Fig. 11)
3. Advance the molding balloon over the wire guide and through the
Captor Hemostatic Valve of the main body introduction system to the
level of the renal arteries. Maintain proper sheath position.
4. Tighten the Captor Hemostatic Valve around the molding balloon with
gentle pressure by turning it clockwise. (Fig. 10)
CAUTION: Do not inflate the balloon in the vessel outside of the
graft.
5. Expand the molding balloon with diluted contrast media (as directed
by the manufacturer) in the area of the most proximal covered stent
and the infrarenal neck, starting proximally and working in the distal
direction. (Fig. 14)
CAUTION: Confirm complete deflation of balloon prior to
repositioning.
CAUTION: Captor Hemostatic Valve must be open prior to
repositioning of the molding balloon.
6. Withdraw the molding balloon to the ipsilateral limb overlap and
expand.
CAUTION: Captor Hemostatic Valve must be open prior to
repositioning of the molding balloon.
7. Withdraw the molding balloon to the ipsilateral distal fixation site and
expand.
CAUTION: Do not inflate the balloon in the vessel outside of the
graft.
CAUTION: Captor Hemostatic Valve must be open prior to
repositioning of the molding balloon.
8. Deflate and remove molding balloon. Transfer molding balloon
onto the contralateral wire guide and into the contralateral iliac leg
introduction system. Advance molding balloon to the contralateral limb
overlap and expand.
CAUTION: Confirm complete deflation of balloon prior to
repositioning.
CAUTION: Captor Hemostatic Valve must be open prior to
repositioning of the molding balloon.
20
9. Withdraw the molding balloon to the contralateral iliac leg/vessel distal
fixation site and expand. (Fig. 14)
CAUTION: Do not inflate the balloon in the vessel outside of the
graft.
10. Remove molding balloon and replace it with an angiographic catheter
to perform completion angiograms.
11. Remove or replace all stiff wire guides to allow iliac arteries to resume
their natural position.
Final Angiogram
1. Position angiographic catheter just above the level of the renal arteries.
Perform angiography to verify that the renal arteries are patent and that
there are no endoleaks. Verify patency of internal iliac arteries.
2. Confirm there are no endoleaks or kinks and verify position of proximal
gold radiopaque markers. Remove the sheaths, wires and catheters.
NOTE: If endoleaks or other problems are observed, refer to the
Suggested Instructions for Use for the Zenith AAA Endovascular Graft
Ancillary Components.
3. Repair vessels and close in standard surgical fashion.
12 IMAGING GUIDELINES AND POSTOPERATIVE FOLLOWUP
For information on imaging guidelines and postoperative follow-up, please
refer to the Instructions for Use for the Zenith AAA main body or Renu that
was used. A copy is available online at www.cookmedical.com.
12.1 General
•Thelong-termperformanceofendovasculargraftswithsecondary
endovascular intervention using additional components has not yet been
established.
•Allpatientsshouldbeadvisedthatendovasculartreatmentrequires
lifelong, regular follow-up to assess their health and the performance
of their endovascular graft. Patients with specific clinical findings (e.g.,
endoleaks, enlarging aneurysms or changes in the structure or position of
the endovascular graft) should receive additional follow-up.
•Patientsshouldbecounseledontheimportanceofadheringtothe
follow-up schedule, both during the first year and at yearly intervals
thereafter. Patients should be told that regular and consistent follow-
up is a critical part of ensuring the ongoing safety and effectiveness of
endovascular treatment of AAAs.
•Physiciansshouldevaluatepatientsonanindividualbasisandprescribe
follow-up relative to the needs and circumstances of each individual
patient. The minimum requirement for patient follow-up (described in the
Instructions for Use for the Zenith AAA main body or Renu that was used)
should be maintained even in the absence of clinical symptoms (e.g.,
pain, numbness, weakness). Patients with specific clinical findings (e.g.,
endoleaks, enlarging aneurysms or changes in the structure or position of
the stent graft) should receive follow-up at more frequent intervals.
•Annualimagingfollow-upshouldincludeabdominalradiographsand
both contrast and non-contrast CT examinations. If renal complications
or other factors preclude the use of image contrast media, abdominal
radiographs, non-contrast CT and duplex ultrasound may be used.
•Thecombinationofcontrastandnon-contrastCTimagingprovides
information on aneurysm diameter change, endoleak, patency, tortuosity,
progressive disease, fixation length and other morphological changes.
•Theabdominalradiographsprovideinformationondeviceintegrity(e.g.,
separation between components, stent fracture).
•Duplexultrasoundimagingmayprovideinformationonaneurysm
diameter change, endoleak, patency, tortuosity and progressive disease.
In this circumstance, a non-contrast CT should be performed to use in
conjunction with the ultrasound. Ultrasound may be a less reliable and
sensitive diagnostic method compared to CT.
•Theminimumimagingfollow-upforpatientswithZenithAAAstentgrafts
is described in the Instructions for Use for the Zenith AAA main body
or Renu that was used, which can be found at www.cookmedical.com.
Patients requiring enhanced follow-up should have interim evaluations.
12.2 Additional Surveillance and Treatment
Additional surveillance and possible treatment is recommended for:
•AneurysmswithTypeIendoleak
•AneurysmswithTypeIIIendoleak
•Aneurysmenlargement≥5mmofmaximumdiameter(regardlessof
endoleak status)
•Migration
•Inadequateseallength
Consideration for reintervention or conversion to open repair should
include the attending physician’s assessment of an individual patient’s
co-morbidities, life expectancy and the patient’s personal choices. Patients
should be counseled that the need for subsequent reinterventions, including
catheter-based and open surgical conversion, are possible following
endograft placement.
12.3 MRI Information
Non-clinical testing has demonstrated that the Zenith Spiral-Z AAA Iliac
Leg Graft is MR Conditional. It can be scanned safely immediately after
placement under the following conditions:
Static Magnetic Field
•Staticmagneticfieldof3.0Teslaorless
•Highestspatialmagneticgradientfieldof720Gauss/cm
Non-clinical evaluation was conducted in a 3 Tesla MR system (General
Electric Excite) with a maximum spatial magnetic gradient field of
720 Gauss/cm as measured with a gaussmeter in the position of the static
magnetic field pertinent to the patient (i.e., outside of scanner covering,
accessible to a patient or individual).
MRI-Related Heating
1.5 Tesla Systems:
•Staticmagneticfieldof1.5Tesla
•Maximumwhole-body-averagedspecificabsorptionrate(SAR)of2W/kg
for 15 minutes of scanning ( i.e., per scanning sequence)
In non-clinical testing, the Zenith Spiral-Z AAA Iliac Leg produced a
temperature rise of less than or equal to 2.1 °C at a maximum whole-body-
averaged specific absorption rate (SAR) of 2.9 W/kg, for 15 minutes of MR
scanning in a 1.5 Tesla, Siemens Medical Magnetom, Numaris/4 Software,
Version Syngo MR 2002B DHHS MR Scanner. The maximum whole-body-
averaged specific absorption rate (SAR) was 2.9 W/kg, which corresponds to
a calorimetry measured value of 2.1 W/kg.
3.0 Tesla Systems:
•Staticmagneticfieldof3.0Tesla
•Maximumwhole-body-averagedspecificabsorptionrate(SAR)of2W/kg
for 15 minutes of scanning( i.e., per scanning sequence)
In non-clinical testing, the Zenith Spiral-Z AAA Iliac Leg produced a
temperature rise of less than or equal to 2.6 °C at a maximum whole-body-
averaged specific absorption rate (SAR) of 2.9 W/kg, for 15 minutes of MR
scanning in a 3.0 Tesla Excite, GE Electric Healthcare, 14X.M5 Software, MR
Scanner. The maximum whole-body-averaged specific absorption rate (SAR)
was 2.9 W/kg, which corresponds to a calorimetry measured value of 2.7 W/kg.
Image Artifact
The image artifact extends throughout the anatomical region containing the
device, obscuring the view of immediately adjacent anatomical structures
within approximately 5 cm of the device, as well as the entire device and its
lumen, when scanned in nonclinical testing using the sequence: Fast spin
echo, in a 3.0 Tesla, Excite, GE Electric Healthcare, with G3.0-052B Software,
MR system with body radiofrequency coil.
For all scanners, the image artifact dissipates as the distance from the device
to the area of interest increases. MR scans of the head and neck and lower
extremities may be obtained without image artifact. Image artifact may be
present in scans of the abdominal region, depending on distance from the
device to the area of interest.
Cook recommends that the patient register the MR conditions disclosed in
this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be
contacted in the following manners.
Mail: MedicAlert Foundation International
2323 Colorado Avenue
Turlock, CA 95382
Phone: 888-633-4298 (toll free)
209-668-3333 from outside the US
Fax: 209-669-2450
Web: www.medicalert.org
13 PATIENT TRACKING INFORMATION
In addition to these Instructions for Use, the Zenith Spiral-Z AAA Iliac Leg
with the Z-Trak Introduction System is packaged with a Device Tracking
Form, which the hospital staff is required to complete and forward to Cook
for the purposes of tracking all patients who receive the Zenith Spiral-Z AAA
Iliac Leg (as required by U.S. Federal Regulation).
Table of contents
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