St. Jude Medical Amplatzer User manual

™
bg: Септално устройство за
затваряне
Инструкции за употреба
hr: Septalni okluder
Upute za uporabu ro: Dispozitiv de închidere de sept
Instrucţiuni pentru utilizare
bs: Septalni okluder
Uputstvo za upotrebu hu: Szeptumtapasz Használati utasítás ru: окклюдер для перегородок Инструкции по применению
cs: Septální okludér
Návod k použití it: Occlusore settale Istruzioni per l'uso sk: Septálny okluzor ventrikulárnych septálnych
defektov
Návod na použitie
da: Septal okklusionsanordning
Brugsanvisning ko: 중격 폐색기
사용 설명서
sl: Septalno zapiralo
Navodila za uporabo
de: Septum-Okkluder
Gebrauchsanweisung lt: Pertvaros okliuderis Naudojimo instrukcija sq: Okludues septal
Udhëzimepërpërdorim
el: Συσκευή απόφραξης
διαφράγματος
Οδηγίες χρήσης
lv: Starpsienas Nosprostotājs
Lietošanas instrukcija sr: Septalni okluder Uputstvo za upotrebu
es: Oclusor septal
Instrucciones de uso nl: Septale occluder Gebruiksaanwijzing sv: Anordning för slutning av septum
Bruksanvisning
et: Vaheseina sulgur
Kasutusjuhend no: Septal lukkeanordning Bruksanvisning tr: Septal Oklüder Kullanma Talimatı
fi: Väliseinäaukon sulkija
Käyttöohjeet pl: Korek do zamykania ubytków przegrody
Instrukcja użytkowania
zh: 房间隔缺损封堵器
使用说明
fr: Dispositif d’occlusion septal
Mode d’emploi pt: Dispositivo de oclusão septal
Instruções de Utilização
ar:
Instructions for Use
Septal Occluder
ﻡﺍﺩﺧﺗﺳﻻﺍ ﺕﺎﻣﻳﻠﻌﺗ
100092311_ASD.book Page 1 Monday, January 6, 2014 11:00 AM

(MR) ﻲﺴﻴﻃﺎﻨﻐﳌﺍ ﲔﻧﺮﻟﺎﺑ ﺮﻳﻮﺼﺘﻟﺍ ﻊﻣ ﻡﺍﺪﺨﺘﺳﻻﺍ ﻁﻭﺮﺷ
Does not contain natural rubber latex components / Не съдържа компоненти от
естествен гумен латекс / Ne sadrži komponente prirodnog gumenog lateksa /
Neobsahuje složky přírodního latexu / Indeholder ikke komponenter af naturlig
gummilatex / Enthält keine Naturlatex-Komponenten / ∆εν περιέχει εξαρτήματα
από φυσικό ελαστικό λάτεξ / No contiene componentes de látex natural / Ei sisalda
naturaalsest latekskummist komponente / Ei sisällä luonnonkumilateksista
valmistettuja osia / Ne contient pas de composants en latex de caoutchouc
naturel / Ne sadrži dijelove od lateksa / Nem tartalmaz természetes gumilatexből
készült alkotóelemeket / Non contiene componenti in lattice di gomma naturale /
천연고무 라텍스 성분 미함유 / Nėra natūralios gumos latekso komponentų/
Nesatur dabiskās gumijas lateksa komponentus / Bevat geen onderdelen van
natuurlijk rubberlatex / Inneholder ikke komponenter i naturgummilateks / Nie
zawiera elementów wykonanych z naturalnej gumy lateksowej / Não inclui
componentes em látex de borracha natural / Nu conţine componente de latex din
cauciuc natural / Не содержит натурального латекса или его компонентов /
Neobsahuje časti z prírodnej latexovej gumy / Ne vsebuje sestavnih delov iz
naravnega lateksa / Nuk përmban përbërës lateksi të gomës natyrale / Ne sadrži
komponente od prirodnog gumenog lateksa / Innehåller inga komponenter av
naturgummi / Doğal kauçuk lateks bileşenler içermez / 不含任何天然乳胶成分 /
MR Conditional / Повлияване от ЯМР / Uslovno siguran kod pregleda MR-om /
Podmíněné vyšetření pomocí MR / Kan anvendes i MR-miljøer under visse
betingelser / Bedingt MR-tauglich / Κατάλληλο για μαγνητική τομογραφία υπό
προϋποθέσεις (MR Conditional) / Compatible con RM en ciertas condiciones /
MR tingimustele vastav / Magneettikuvantamisolosuhteet (MK) / Compatibilité
avec l'IRM / Dopuštena uvjetna upotreba MR-a / Feltételes MR-kompatibilitás /
Sicuro per la risonanza magnetica (RM) in condizioni specifiche / MR 조건부
안전 / Sąlyginai atsparus MR / Drošs lietošanai ar MR noteiktos apstākļos /
MR-veilig onder bepaalde voorwaarden / MR-sikker under visse betingelser /
Warunkowe użycie z MR / Condicional para RM / Acceptat MR în anumite
condiţii / Условно пригодно для использования вМР-окружении / Podmienky
vystavenia MR / Pogojna uporaba z magnetno resonanco (MR) / Kushtëzimi nga
MR-ja / Uslovno bezbedno u MR okruženju / MR-säker under vissa betingelser /
Koşullu MR / 有条件磁共振安全 /
Inner diameter / Вътрешен диаметър / Unutrašnji prečnik / Vnitřní průměr/
Indvendig diameter / Innendurchmesser / Εσωτερική διάμετρος / Diámetro interno /
Sisediameeter / Sisäläpimitta / Diamètre interne / Unutarnji promjer / Belsőátmérő/
Diametro interno / 내경 / Vidinis skersmuo / Iekšējais diametrs / Binnendiameter /
Innvendig diameter / Średnica wewnętrzna / Diâmetro interior / Diametru interior /
Внутренний диаметр / Vnútorný priemer / Notranji premer / Diametri i brendshëm /
Unutrašnji prečnik / Innerdiameter / İç çap / 内径 /
Outer diameter / Външен диаметър / Vanjski prečnik / Vnější průměr / Udvendig
diameter / Außendurchmesser / Εξωτερική διάμετρος / Diámetro externo /
Välisdiameeter / Ulkoläpimitta / Diamètre externe / Vanjski promjer / Külsőátmérő/
Diametro esterno / 외경 / Išorinis skersmuo / Ārējais diametrs / Buitendiameter /
Utvendig diameter / Średnica zewnętrzna / Diâmetro exterior / Diametru exterior /
Наружный диаметр / Vonkajší priemer / Zunanji premer / Diametri i jashtëm /
Spoljni prečnik / Ytterdiameter / Dışçap / 外径 /
Length / Дължина / Dužina / Délka / Længde / Länge / Μήκος / Longitud / Pikkus /
Pituus / Longueur / Duljina / Hosszúság / Lunghezza / 길이 / Ilgis / Garums /
Lengte / Lengde / Długość / Comprimento / Lungime / Длина / Dĺžka / Dolžina /
Gjatësia / Dužina / Längd / Uzunluk / 长度 /
Usable length / Полезна дължина / Upotrebljiva dužina / Využitelná délka /
Brugbar længde / Nutzbare Länge / Χρησιμοποιήσιμο μήκος / Longitud útil /
Tööpikkus / Käyttöpituus / Longueur utile / Korisna duljina / Hasznos hosszúság /
Lunghezza utile / 사용 가능 길이 / Tinkamas naudoti ilgis / Lietderīgais garums /
Bruikbare lengte / Arbeidslengde / Długość użytkowa / Comprimento útil /
Lungime utilă/ Полезная длина / Využiteľná dĺžka / Uporabna dolžina /
Gjatësia e përdorur / Korisna dužina / Arbetslängd / Kullanılabilir uzunluk /
可用长度 /
100092311_ASD.book Page 2 Monday, January 6, 2014 11:00 AM

Recommended delivery sheath dimensions / Препоръчителни размери на
маншона за въвеждане / Preporučene dimenzije uvodnice / Doporučené
rozměry zaváděcího pouzdra / Anbefalede dimensioner for indføringshylster /
Empfohlene Maße der Einführschleuse / Συνιστώμενες διαστάσεις θηκαριού
προώθησης / Dimensiones recomendadas del introductor / Soovitatavad
sisestuskateetri mõõtmed / Suositellut sisäänviejäholkin mitat / Dimensions
recommandées pour la gaine de pose / Preporučene dimenzije uvodne cjevčice /
A bevezetőhüvely ajánlott méretei / Dimensioni consigliate per la guaina di
introduzione / 권장 쉬스 치수 / Rekomenduojami įvedimo movos išmatavimai /
Ieteiktie ievadīšanas apvalka izmēri / Aanbevolen afmetingen plaatsingsschacht /
Anbefalte mål for innføringshylse / Zalecane wymiary koszulki wprowadzającej /
Dimensões da bainha introdutora recomendadas / Dimensiunile recomandate ale
tecii de aplicare / Рекомендуемые размеры доставочной капсулы / Odporúčané
rozmery zavádzacieho puzdra / Priporočene dimenzije uvajalnega tulca /
Përmasat e rekomanduara të mbështjelljes / Preporučene dimenzije dopremnog
omotača / Rekommenderade dimensioner för införingsskidan / Önerilen taşıma
kılıfıboyutları/ 推荐的传送鞘管尺寸 /
Do not use if package is damaged. / Да не се използва, ако опаковката е
повредена. / Ne koristiti ako je pakovanje oštećeno. / Nepoužívejte,
je-li balení poškozeno. / Produktet må ikke anvendes, hvis pakken er beskadiget. /
Bei beschädigter Packung nicht verwenden. / Μη χρησιμοποιείτε αν ησυσκευασία
έχει υποστεί ζημιά. / No utilice este producto si el envase está dañado. / Ärge
kasutage, kui pakend on vigastatud. / Ei saa käyttää, jos pakkaus on vaurioitunut. /
Ne pas utiliser si l’emballage est endommagé. / Nemojte upotrebljavati ako je omot
oštećen. / Ne használja, ha a csomagolás sérült. / Non usare se la confezione è
danneggiata. / 포장이 손상된 경우 사용하지 마십시오 . / Nenaudoti, jei pakuotėyra
pažeista. / Nelietot, ja iepakojums ir bojāts. / Niet gebruiken als de verpakking is
beschadigd. / Må ikke brukes hvis pakken er skadet. / Nie używać, jeżeli
opakowanie jest uszkodzone. / Não usar se a embalagem estiver danificada. / Nu
utilizaţi dacăambalajul este deteriorat. / Не использовать, если упаковка
повреждена. / Nepoužívajte, ak je obal poškodený. / Ne uporabljajte, če je
embalaža poškodovana. / Mos e përdorni nëse është dëmtuar ambalazhi. / Ne
koristiti ako je pakovanje oštećeno. / Får ej användas om förpackningen är
skadad. / Ambalaj hasar görmüşse kullanmayın. / 如果包装已破损，请不要使用。/
.
Package contains 1 item / Опаковката съдържа 1 артикул / Pakovanje sadrži
jednu stavku / Balení obsahuje 1 položku / Pakken indeholder 1 genstand /
Packung enthält: 1 Stück / Το πακέτο περιέχει 1 στοιχείο / El paquete contiene
1 artículo / Pakend sisaldab 1 seadet / Pakkaus sisältää 1 nimikkeen / 1 article par
emballage / Pakiranje sadrži 1 artikal / A csomagolás 1 tételt tartalmaz / Pakuotėje
yra 1 dalis / 포장에 1 가지 품목 포함 / La confezione contiene 1 articolo /
Lepakojumā1 vienība / De verpakking bevat 1 item / Pakken inneholder 1 artikkel
/ Opakowanie zawiera 1 sztukę/ A embalagem contém 1 item / Ambalajul conţine
1 element / Упаковка содержит 1 ед. продукции / Balenie obsahuje 1 kus /
Pakiranje vsebuje 1 artikel / Paketa përmban 1 artikull / Pakovanje sadrži 1 artikal
/ Förpackningen innehåller 1 produkt / Ambalajda 1 ürün bulunmaktadır / 1 件包装
/
Septal Occluder/ Септално устройство за затваряне / Septalni okluder / Septální
okludér / Septal okklusionsanordning / Septum-Okkluder / Συσκευή απόφραξης
διαφράγματος / Oclusor septal / Vaheseina sulgur / Väliseinäaukon sulkija /
Dispositif d’occlusion septal / Septalni okluder / Szeptumtapasz / Occlusore settale
/ 중격 폐색기 / Pertvaros okliuderis / Starpsienas Nosprostotājs / Septale occluder
/ Septal lukkeanordning / Korek do zamykania ubytków przegrody / Dispositivo de
oclusão septal / Dispozitiv de închidere de sept / Окклюдер для перегородок /
Septálny okluzor ventrikulárnych septálnych defektov / Septalno zapiralo /
Okludues septal / Septalni okluder / Anordning för slutning av septum / Septal
Oklüder / 房间隔缺损封堵器 /
ﻢﻴﻠﺴﺘﻟﺍ ﺪﻤﻏ ﺕﺎﺳﺎﻴﻗ
Septal Occluder
100092311_ASD.book Page 3 Monday, January 6, 2014 11:00 AM

Federal law (USA) restricts this device to sale by or on the order of a physician (or
properly licensed practitioner). / Според федералното законодателство (на
САЩ) продажбата на това устройство може да стане само по поръчка на
лекар (или на съответно лицензиран здравен работник). / Savezni zakon
(SAD) ograničava prodaju ovog uređaja samo ljekaru ili po narudžbi ljekara (ili
ljekara praktičara sa ispravnom licencom). / Federální zákon (USA) povoluje
prodej tohoto zařízení jen na objednávku lékaře (nebo zdravotníka s náležitou
licencí). / Ifølge amerikansk lovgivning (USA) må denne anordning kun sælges af
eller efter ordinering af en læge (eller andet autoriseret sundhedspersonale). /
Nach US-amerikanischem Recht darf dieses Produkt nur auf ärztliche Anordnung
(oder auf Anordnung eines lizenzierten Mediziners) verkauft werden. / Η
ομοσπονδιακή νομοθεσία των Η.Π.Α. περιορίζει την πώληση της συσκευής αυτής
μόνο από ιατρό ήκατόπιν εντολής ιατρού (ήεντεταλμένου επαγγελματία του
τομέα υγείας). / La ley federal de los Estados Unidos permite la venta de este
dispositivo únicamente a médicos o bajo prescripción facultativa (o de un
profesional debidamente autorizado). / Ameerika Ühendriikide föderaalseadused
lubavad käesolevat toodet müüa ainult arsti (või litsentseeritud isiku) tellimusel või
loal. / Yhdysvaltain liittovaltion lain mukaan tämän laitteen saa myydä vain lääkäri
tai lääkärin määräyksestä. / La loi fédérale (des États-Unis) limite la vente de ce
dispositif aux médecins (ou aux praticiens titulaires d’une licence) ou sur
ordonnance médicale. / Savezni zakon (SAD) ograničava prodaju ove naprave
samo liječniku ili po narudžbi liječnika (ili praktičara s ispravnim odobrenjem). / Az
Amerikai Egyesült Államok szövetségi törvényei értelmében az eszköz csak
szakorvos (vagy megfelelőengedéllyel rendelkezőorvos) által vagy
rendelvényére értékesíthető. / Le leggi federali statunitensi limitano la vendita di
questo dispositivo a medici o a personale qualificato oppure in possesso di
prescrizione medica. / 연방 법률 ( 미국 ) 은 이 기기를 의사 ( 또는 적절한 허가를 받
은 의료인 ) 가 직접 판매하거나 의사의 지시에 의해서만 판매할 수 있도록 제한합
니다 . / Federalinis įstatymas (JAV) leidžia pardavinėti šiuos įtaisus tik
gydytojams (ar tinkamai licencijuotiems praktikams) arba jųnurodymu. / Saskaņā
ar ASV federālo likumu šo ierīci drīkst pārdot tikai ārstiem un atbilstoši licencētiem
medicīnas darbiniekiem vai abu minēto kategoriju pilnvarotām personām. /
Volgens de Amerikaanse wetgeving mag dit hulpmiddel alleen door of op
voorschrift van een arts (of gediplomeerd beoefenaar van de geneeskunde)
worden verkocht. / Føderal lov (i USA) begrenser salg av dette utstyret til lege
eller etter forordning fra lege (eller kvalifisert helsepersonell). / Prawo federalne
(USA) dopuszcza sprzedażtego urządzenia wyłącznie przez lekarza lub na jego
polecenie (lub posiadającego odpowiednie uprawnienia pracownika służby
zdrowia). / A lei federal dos E.U.A. limita a venda deste dispositivo a médicos ou
sob receita destes (ou profissional paramédico devidamente licenciado). / Legile
federale (SUA) permit vânzarea acestui dispozitiv numai cu sau pe bazăde reţetă
eliberatăde medic (sau alt specialist cu licenţă adecvată). / Всоответствии с
федеральным законом США продажа данного устройства разрешается
только врачу (или практикующему врачу ссоответствующей лицензией) или
по его предписанию. / Federálny zákon (USA) povoľuje predaj tohto zariadenia
lekárom alebo na objednávku od lekára (alebo riadne registrovaného
zdravotníckeho pracovníka). / Zvezni zakon (ZDA) omejuje prodajo tega
pripomočka samo zdravnikom ali po naročilu zdravnika (oz. strokovne osebe s
primerno licenco). / Ligji federal (SHBA) parashikon shitjen e kësaj pajisjeje vetëm
nga një mjek apo me rekomandim nga mjeku (apo praktikanti i licencuar). /
Američki federalni zakon ograničava prodaju ovog uređaja tako da se vrši od
strane ili na recept lekara (ili zdravstvenog radnika sa odgovarajućom licencom). /
Enligt amerikansk federal lag får denna anordning endast säljas av eller på order
av läkare (eller behörig legitimerad sjukvårdspersonal). / Bu cihazın satışı, ABD
federal yasalarına göre sadece hekimlerce (ya da uygun ruhsatlıpratisyenlerce)
veya onların emri uyarınca yapılabilir. / 美国联邦法律限定本产品只能由医生 （或
具有适当执照的医务人员）销售或凭医嘱销售。 /
ﻩﺬﻫ ﻊﻴﺑ ﺮﺼﺘﻘﻳ (ﺔﻴﻜﻳﺮﻣﻷﺍ ﺓﺪﺤﺘﻤﻟﺍ ﺕﺎﻳﻻﻮﻠﻟ) ﻲﻟﺍﺭﺪﻴﻔﻟﺍ ﻥﻮﻧﺎﻘﻟﺍ ﺐﺟﻮﻤﺑ
.(ﺺﺧﺮﻣ ﺔﺤﺻ ﺱﺭﺎﻤﻣ ﻭﺃ) ﺐﻴﺒﻄﻟﺍ ﻦﻣ ﺮﻣﺃ ﻰﻠﻋ ﺓﺍﺩﻷﺍ
100092311_ASD.book Page 4 Monday, January 6, 2014 11:00 AM

en: Instructions for Use ...................................................................................1
bg: Инструкции за употреба........................................................................15
bs: Uputstvo za upotrebu ..............................................................................23
cs: Návod k použití........................................................................................30
da: Brugsanvisning........................................................................................37
de: Gebrauchsanweisung..............................................................................44
el: Οδηγίες χρήσης........................................................................................52
es: Instrucciones de uso................................................................................60
et: Kasutusjuhend..........................................................................................67
fi: Käyttöohjeet...............................................................................................74
fr : Mode d’emploi..........................................................................................81
hr: Upute za uporabu.....................................................................................88
hu: Használati utasítás..................................................................................95
it: Istruzioni per l'uso....................................................................................102
ko: 사용 설명서...........................................................................................109
lt: Naudojimo instrukcija ..............................................................................115
lv: Lietošanas instrukcija .............................................................................122
nl: Gebruiksaanwijzing ................................................................................129
no: Bruksanvisning......................................................................................136
pl: Instrukcja użytkowania ...........................................................................143
pt: Instruções de Utilização .........................................................................151
ro: Instrucţiuni pentru utilizare .....................................................................158
ru: Инструкции по применению.................................................................165
sk: Návod na použitie..................................................................................173
sl: Navodila za uporabo...............................................................................180
sq: Udhëzime për përdorim.........................................................................187
sr: Uputstvo za upotrebu .............................................................................194
sv: Bruksanvisning ......................................................................................201
tr: Kullanma Talimatı...................................................................................208
zh: 使用说明...............................................................................................215
ar: ....................................................................................221
ﻡﺍﺩﺧﺗﺳﻻﺍ ﺕﺎﻣﻳﻠﻌﺗ
100092311_ASD.book Page 1 Monday, January 6, 2014 11:00 AM

1
AMPLATZER™ Septal Occluder
en: Instructions for Use
Device Description
The AMPLATZER™ Septal Occluder is a self-expanding nitinol mesh, double-disc occlusion
device for use in atrial septal defects. The 2 discs are connected by a short waist with a waist
diameter that corresponds to the atrial defect size. To increase its closing ability, the device is filled
with polyester fabric that is securely sewn to each disc by a polyester thread. Radiopaque marker
bands at each end of the device provide visualization under fluoroscopy.
The AMPLATZER™ 45° Delivery System was designed to facilitate attachment, loading, delivery,
and deployment of the AMPLATZER™ Occluders and is composed of:
• Delivery sheath with hemostasis valve – provides a pathway through which an
AMPLATZER™ device is delivered
• Dilator – eases penetration of tissue and minimizes vessel trauma
• Loader – introduces an AMPLATZER™ device into the sheath
• Plastic vise – attaches to the delivery cable and serves as a handle for disconnecting
(unscrewing) the delivery cable from a device
• Delivery cable – attaches to the device to control its movements through the sheath
Refer to the figures and tables on the foldout of the back cover for more information about the
device. Device and delivery sheath dimensions are provided in table T1. The following device
components are identified in the figures.
Indications and Usage
The AMPLATZER™ Septal Occluder is a percutaneous, transcatheter atrial septal defect closure
device intended for the occlusion of atrial septal defects (ASDs) in secundum position or patients
who have undergone a fenestrated Fontan procedure and who now require closure of the
fenestration.
Patients indicated for ASD closure have echocardiographic evidence of ostium secundum atrial
septal defect and clinical evidence of right ventricular (RV) volume overload (ie, 1.5:1 degree of
left-to-right shunt or RV enlargement).
Contraindications
The AMPLATZER™ Septal Occluder is contraindicated for:
• Patients known to have extensive congenital cardiac anomaly that can only be adequately
repaired by cardiac surgery.
• Patients known to have sepsis within 1 month prior to implantation, or patients with any
systemic infection that cannot be successfully treated before device placement.
• Patients known to have a bleeding disorder, untreated ulcer, or any other contraindications to
aspirin therapy, unless another antiplatelet agent can be administered for 6 months after
device placement.
• Patients who are unable to take antiplatelet or anticoagulant therapy.
• Patients known to have demonstrated intracardiac thrombus on echocardiography
(especially left atrial or left atrial appendage thrombi).
Figure F1 Figure F2
A. Device waist diameter E. Loader
B. Left atrial disc F. Hemostasis valve
C. Right atrial disc G. Delivery sheath
D. Device waist length H. Dilator
I. Delivery cable
J. Plastic vise
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• Patients whose size or condition (eg, too small for transesophageal echocardiography [TEE]
probe, catheter size, vasculature size, active infection) would cause the patient to be a poor
candidate for cardiac catheterization.
• Patients with defect margins less than 5 mm to the coronary sinus, inferior vena cava rim, an
atrioventricular valve, or the right upper lobe pulmonary vein.
Warnings
• Embolized devices must be removed because they may cause patient harm. Embolized
devices should not be withdrawn through intracardiac structures unless they have been
collapsed within a sheath.
• Implantation of this device may not replace the need for anticoagulation therapy in patients
with ASD and paradoxical embolism.
• Do not use a syringe to aspirate the device. Use the hemostasis valve to control blood
backflow during the implant procedure.
• Do not use a power injection syringe to inject contrast solution through the sheath.
• The use of transthoracic, transesophageal, or intracardiac echocardiographic imaging (TTE,
TEE, or ICE) is required before, during, and after implantation. Imaging is mandatory as an
aid in positioning the sheath through the most suitable defect to achieve complete closure of
the defect. If TEE is used, the patient’s esophageal anatomy must be adequate for the
placement and manipulation of the TEE probe.
• Balloon sizing should be used to size the atrial septal defect using a stop-flow technique. Do
not inflate the balloon beyond the cessation of the shunt (i.e., stop-flow). DO NOT
OVERINFLATE.
• Physicians should be aware of the risk of erosion. Erosion may be the result a complex set of
interactions between factors including, but not limited to the underlying anatomic substrate,
retro-aortic rim of less than 5mm in any echocardiographic plane, and the dynamic
hemodynamic counter-motion between the atrium and the aorta. However, there is
insufficient data including inadequate echocardiographic information about the cases already
reported to determine etiology of erosion.
• Do not select a device size larger than 1.5 times the ASD diameter measured by
echocardiography before balloon sizing.
• Do not release the device from the delivery cable if the device does not conform to its original
configuration or if the device position is unstable or if the device interferes with any adjacent
cardiac structure, such as superior vena cava (SVC), pulmonary vein (PV), mitral valve (MV),
coronary sinus (CS) or aorta (AO). Recapture the device and redeploy. If still unsatisfactory,
recapture the device and replace with a new device.
• Placement of the ASD occluder may impact future cardiac interventions, for example
transseptal puncture and mitral valve repair.
• Patients who are allergic to nickel may have an allergic reaction to this device.
• Do not use the device if the packaging sterile barrier is open or damaged.
• Use on or before the last day of the expiration month noted on the product packaging.
• The device is sterilized using ethylene oxide and is for single use only. Do not reuse or
resterilize. Attempts to resterilize the device may result in device malfunction, inadequate
sterilization, or patient harm.
• Physicians must be prepared to deal with urgent situations, such as device embolization,
which require removal of the device. This includes the availability of an on-site surgeon.
• This device should only be used by physicians who have been trained in transcatheter
techniques. The physician should determine which patients are suitable candidates for
procedures using this device.
Precautions
• The use of this device has not been studied in patients with patent foramen ovale.
• Use standard interventional cardiovascular catheterization techniques when using
AMPLATZER™ products.
• The physician should exercise clinical judgment in situations that involve the use of
anticoagulants or antiplatelet drugs before, during, and/or after implantation of this device.
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• Patient Selection
Certain patients may be at higher risk for complications such as tissue erosion and device
embolization. If higher-risk patients have devices implanted, closer follow-up is warranted
(see the Post-Procedure Instructions section). Higher risk patients include:
- Patients with deformation of the device at the aortic root.
- Patients with high defects (minimal aortic and superior rims).
- Patients with IVC rim deficiency (risk of device embolization).
Patients with multiple ASDs
Closure of multiple ASDs should only be attempted by physicians who have gained
sufficient experience (more than 10–15 cases) to undertake more technically
challenging procedures.
- If 2 large ASDs are separated by more than a 7 mm rim of tissue implantation of 2
devices may be justified.
- If multiple fenestrations are close to each other, one device may be used to cover all
defects when placed in the largest defect.
• Use in specific populations
- Pregnancy – care should be taken to minimize the radiation exposure to the fetus and
the mother.
- Nursing mothers – there has been no quantitative assessment of the presence of
leachables in breast milk.
• MR Conditional1
Through non-clinical testing, AMPLATZER™ devices have been shown to be MR
Conditional. A patient with an implanted AMPLATZER™ device can be scanned safely
immediately after placement of the device under the following conditions:
- Static magnetic field of 3 T or less
- Spatial gradient magnetic field of 720 G/cm or less
- Maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of
3 W/kg for 15 minutes of scanning
During testing, the device produced a clinically non-significant temperature rise at a
maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 3 W/
kg for 15 minutes of scanning in a 3-tesla MR system using a transmit/receive body coil.
MR image quality may be compromised if the area of interest is in the exact same area or
relatively close to the position of the device. Therefore, optimization of MR imaging
parameters to compensate for the presence of this device may be necessary.
Adverse Events
Observed Adverse Events – Tissue Erosion
Tissue erosion refers to the erosion or abrasion of the tissue of the atrium, primarily in the area of
the roof of either or both atria, and or the adjacent aortic root (non-coronary sinus). The estimated
incidence of tissue erosion based on retrospective meta-analyses has been reported in literature
to be as high as 0.1 to 0.3%.2Tissue erosion, while rare, is a surgical emergency due to the
impending risk or the actual occurrence of hemodynamic instability resulting from cardiac
tamponade, and may lead to severe morbidity or death. Absence of the retro-aortic rim and device
oversizing may be associated factors relating to the incidence of erosion.
1. MR Conditional as defined in ASTM F 2503-05.
2. Crawford GB, Brindis RG, Krucoff MW, et al. Percutaneous atrial Septal Occluder devices and
cardiac erosion: A review of the literature. Article first published online: 2 MAY 2012. DOI: 10.1002/
ccd.24347
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Potential Adverse Events
Potential adverse events that may occur during or after a procedure placing this device include,
but are not limited to air embolus, allergic reaction, apnea, arrhythmia, arteriovenous fistulae,
bleeding, brachial plexus injury, cardiac perforation, cardiac tamponade, death, device
embolization/migration, dissection, endocarditis, erosion, fever, foreign material embolic event,
headache/migraine, heart block, hematoma/pseudoaneurysm including blood loss requiring
transfusion, hemolysis, hypertension/hypotension, infection, myocardial infarction, perforation,
pericardial effusion, peripheral embolism, peripheral pulse loss, phrenic nerve injury, pleural
effusion, residual shunt, stroke/transient ischemic attack, thromboembolic event, thrombus
formation/embolization, tissue trauma/damage, valve damage, valvular insufficiency, vascular
access site complications, vessel trauma/damage.
Clinical Studies
See the Clinical Studies section in English on page 4 for clinical data.
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Clinical Summary
The AMPLATZER™ Septal Occluder was evaluated in a multi-center, non-randomized, pivotal
study comparing the device to surgical closure of atrial septal defects (ASDs); 423 patients
received 433 devices with a total device exposure of 911.5 years. Individual patient exposure to
the device averaged 25.6 months (ranging from 0 to 38.9).
A Registry group was also studied to evaluate the device in patients with other conditions
appropriate for device closure. Forty-eight (48) patients with Fenestrated Fontan (communication
in the baffle with at least 5 mm distance from the free atrial wall and central venous pressure less
than 15 mm Hg) were enrolled in the study.
Deaths
There was one non-device or procedure-related death reported in the pivotal study, and no deaths
were reported in the Fenestrated Fontan Registry Group.
Observed Adverse Events
Pivotal Clinical Study
Table 1. Adverse Events – Pivotal Study
AMPLATZER™
Patients
Surgical
Control
Patients p-value
Major Adverse Events
Cardiac arrythmia requiring major treatment 2/442 (0.5%) 0/154 (0.0%) 1.00
Device embolization with surgical removal 3/442 (0.7%) 0/154 (0.0%) 0.57
Device embolization with percutaneous removal 1/442 (0.2%) 0/154 (0.0%) 1.00
Delivery system failure 1/442 (0.2%) 0/154 (0.0%) 1.00
Pericardial effusion with tamponade 0/442 (0.0%) 3/154 (1.9%) 0.017
Pulmonary edema 0/442 (0.0%) 1/154 (0.6%) 0.26
Repeat surgery 0/442 (0.0%) 2/154 (1.3%) 0.066
Surgical wound adverse events 0/442 (0.0%) 2/154 (1.3%) 0.066
Total Major Adverse Events (Patients) 7/442 (1.6%) 8/154 (5.2%) 0.030
Minor Adverse Events
Anemia 0/442 (0.0%) 1/154 (0.6%) 0.26
Allergic reaction (drug) 2/442 (0.5%) 0/154 (0.0%) 1.00
Atelectasis 0/442 (0.0%) 1/154 (0.6%) 0.26
Cardiac arrythmias minor treatment 15/442 (3.4%) 9/154 (5.8%) 0.23
Device embolization with percutaneous removal 1/442 (0.2%) 0/154 (0.0%) 1.00
Extremity tingling/numbness 1/442 (0.2%) 0/154 (0.0%) 1.00
Headaches/possible TIA 2/442 (0.5%) 0/154 (0.0%) 1.00
Delivery system failure 2/442 (0.5%) 0/154 (0.0%) 1.00
Pericardiotomy syndrome 0/442 (0.0%) 2/154 (1.3%) 0.066
Pericardial effusion 0/442 (0.0%) 6/154 (3.9%) <0.001
Pleural effusion 0/442 (0.0%) 1/154 (0.6%) 0.26
Pneumothorax 0/442 (0.0%) 3/154 (1.9%) 0.017
Staph infection 0/442 (0.0%) 1/154 (0.6%) 0.26
Surgical wound adverse events 0/442 (0.0%) 1/154 (0.6%) 0.26
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Registry Group – Fenestrated Fontan
Clinical Studies
The AMPLATZER™ Septal Occluder was evaluated in a multi-center, non-randomized controlled
study to compare the clinical performance of the device for ASD closure with that documented for
the ASD surgical repair procedure. Additionally, the device was studied in patients with uncommon
conditions wherein transcatheter closure with the device may also be beneficial (Registry Group).
Patients Studied
Pivotal Study – Atrial Septal Defects
Attempt to treat was initiated in 442 device patients and 154 surgical patients. Enrolled patients
had echocardiographic evidence of ostium secundum atrial septal defect (device group: defect
size 38 mm) and clinical evidence of right ventricular volume overload or had clinical symptoms
such as paradoxical embolism or atrial dysrrhythmia in the presence of a minimal shunt. Exclusion
criteria included:
• Patients with multiple defects that could not be covered adequately by the device (device
group only).
• Associated congenital cardiac anomalies requiring surgery.
• Ostium primum or sinus venosus atrial septal defects.
• Partial anomalous pulmonary venous drainage.
• Pulmonary vascular resistance above 7 Woods units or a right-to-left shunt at the atrial level
with a peripheral arterial saturation less than 94%.
• Patients with recent myocardial infarction, unstable angina and decompensated congestive
heart failure.
• Patient with right and/or left ventricular decompensation with ejection fraction less than 30%.
• Sepsis (local/generalized).
• History of repeated pulmonary infection.
Thrombus formation 3/442 (0.7%) 0/154 (0.0%) 0.56
Transfusions 0/442 (0.0%) 2/154 (1.3%) 0.066
Upper respiratory infection/fever 0/442 (0.0%) 2/154 (1.3%) 0.066
Urinary tract disturbance 1/442 (0.2%) 0/154 (0.0%) 1.00
Total Minor Adverse Events (Patients) 27/442 (6.1%) 29/154 (18.8%) <0.0001
Table 2. Adverse Events – Fenestrated Fontan
AMPLATZER™ Patients Upper 95%
Confidence Bound
Major Adverse Events
Repeat surgery 1/48 (2.1%) 0.095
Hemothorax 1/48 (2.1%) 0.095
Minor Adverse Events 1/48 (2.1%) 0.095
Vomiting (required 2 nights in hospital) 1/48 (2.1%) 0.095
Atrial fibrillation/cardioversion 1/48 (2.1%) 0.095
Total Adverse Events 4/48 (8.3%) 0.181
Table 1. Adverse Events – Pivotal Study
AMPLATZER™
Patients
Surgical
Control
Patients p-value
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• Any type of serious infection less than 1 month prior to procedure.
• Malignancy where life expectancy was less than 2 years.
• Demonstrated intracardiac thrombi on echocardiography.
• Weight less than 8 kg.
• Inability to obtain informed consent.
• Patient with gastritis, gastric ulcer, duodenal ulcer, bleeding disorders, etc., and other
contraindications to aspirin therapy unless other antiplatelet agents could not be
administered for 6 months.
Patients underwent physical examination that included heart murmur classification,
electrocardiogram, chest x-ray, and 2D color Doppler transthoracic echocardiogram (TTE).
Table 3. Patient Baseline Demographics
Variable AMPLATZER™
Patients Surgical Control Patients p-value
Age (years) Mean ± s.d.(N) 18.1 ±19.3 (442) 5.9 ±6.2 (154) <0.001
[range] [0.6, 82.0] [0.6, 38.2]
Gender Female 299/442 (67.6%) 94/154 (61.0%) 0.14
Male 143/442 (32.4%) 60/154 (39.0%)
Height (cm) Mean ± s.d.(N) 134.6 ± 32.0 (440) 105.5 ± 26.9 (151) <0.001
[range] [58,188] [60,178]
Weight (kg) Mean ± s.d.(N) 42.3 ± 27.3 (440) 20.6 ± 15.2 (153) <0.001
[range] [6.3, 130 [4.8, 78.4]
Medical History
CHF 11/442 (2.5%) 7/154 (4.5%) 0.27
Failure to thrive 14/442 (3.2%) 13/154 (8.4%) 0.012
CAD 9/442 (2.0%) 0/154 (0%) 0.12
Respiratory infections 7/442 (1.6%) 13/154 (8.4%) <0.001
TIA 6/442 (1.4%) 1/154 (0.6%) 0.68
COPD 1/442 (0.2%) 0/154 (0%) 1.00
Hypertension 16/442 (3.6%) 0/154 (0%) 0.016
Stroke 13/442 (2.9%) 0/154 (0%) 0.026
Recurrent strokes/TIAs 5/442 (1.1%) 1/154 (0.6%) 1.00
Diabetes 4/442 (0.9%) 0/154 (0%) 0.58
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Registry Group – Fenestrated Fontan
Methods
Device Patients
Device placement was attempted in 442 patients. The patients underwent cardiac catheterization.
Position and size of the defect were confirmed by angiography. The size of the defect was
determined by obtaining the "stretched" diameter of the defect with a compliant balloon catheter. If
the size and position of the defect were determined to be feasible for transcatheter closure, device
placement was attempted. Nineteen (19) patients did not receive the device due to anatomical
conditions. There was one acute embolization. Thus 423 patients received 433 devices. The
patients were instructed to avoid strenuous activity for a period of 1 month and to take aspirin for 6
months post placement (3-5mg/kg/day). Additionally, patients were examined and a transthoracic
echocardiogram (TTE) was conducted at 24 hours, 6 months, and 1 year.
Surgical Control Group
Surgical repair of an atrial septal defect requires sternotomy, cardiopulmonary bypass, aortic cross
clamp and right atriotomy. If the defect is small, primary repair by suturing the defect is feasible;
however, if the defect is large, then patch closure is the preferred method. Different surgeons use
different material for the patch. Most surgeons use pericardium, however, some surgeons use
GORE-TEX to repair the ASD. At the end of the operation, the surgeon inserts chest tubes to drain
any blood. The chest tubes remain for 24–48 hours after which they are removed. The patient
spends 3–5 days at the hospital after which they go home. A total of 154 patients underwent
surgical closure of their ASD. The surgical group required a 12-month visit.
Table 4. Pre-closure – Fenestrated Fontan
Age (years) Mean ± s.d.(N) 7.8 ± 6.9 (48)
[range] [1.6, 44.9]
Gender Female 29/48 (60.4%)
Male
Height (cm) Mean ± s.d.(N) 114.5 ± 25.2 (46)
[range] [78,168]
Weight (kg) Mean ± s.d.(N) 22.4 ± 13.5 (48)
[range] [9.7, 68.7]
Medical History
CHF 1/48 (2.1%)
Failure to thrive 1/48 (2.1%)
Stroke 2/48 (4.2%)
Heart murmur 26/47 (55.3%)
Pulmonary ejection murmur 2/47 (4.3%)
Mid diastolic murmur 1/47 (2.1%)
Right axis deviation 11/45 (24.4%)
Peaked P-waves 1/45 (2.2%)
Cardiomegaly 20/45 (44.4%)
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Results
Technical Success: Successful deployment of the device, or the successful completion of the
surgical procedure.
Procedure Success: Successful closure of the defect as measured immediately following the
procedure (less than or equal to 2 mm residual shunt).
Composite Success: All device placement attempts without a major adverse event, surgical
reintervention, embolization, technical failure, or major shunt (defined as greater than 2 mm).
Closure Success: Among patients that were technical successes, closure of the atrial septal
defect (defined as a shunt less than or equal to 2 mm) without the need for surgical repair.
Major Adverse Events: Events that are life threatening, prolong hospitalization, or have long term
consequences or need for ongoing therapy. These include but are not limited to cerebral
embolism, cardiac perforation with tamponade, endocarditis, pericardial effusion with tamponade,
repeat surgery, death, cardiac arrhythmias requiring permanent pacemaker placement or long
term anti-arrhythmia medication, and device embolizations requiring immediate surgical removal.
Minor Adverse Events: Device embolization with percutaneous retrieval, cardiac arrhythmia with
treatment, phrenic nerve injury, hematoma, other vascular access site adverse events,
retroperitoneal hematoma, surgical wound adverse events, other procedural adverse events,
pericardial effusion requiring medical management, evidence of device associated thrombus
formation without embolization (with or without treatment), and marker band embolization without
known sequelae.
Table 5. Principal Effectiveness and Safety Results — Pivotal Study
AMPLATZER™
Patientsa
a. Unit of analysis = Patient. Although 10 patients had 2 defects each treated with an
AMPLATZER™ Septal Occluder, all patients with multiple AMPLATZER™ implants were
successfully treated.
Surgical Control
Patients 90% Confidence Interval
Technical Success 423/442 (95.7%) 154/154 (100%) (-0.084, -0.010)
Procedure Success 413/423 (97.6%) 154/154 (100%) (-0.059, +0.008)
Early (30 days) Composite Success 401/442 (90.7%) 148/154 (96.1%) (-0.096, +0.019)
12-month Composite Success 331/362 (91.4%) 146/154 (94.8%) (-0.153, -0.033)
24-hour Closure Success 404/418 (96.7%) 154/154 (100%) (-0.073, -0.001)
6-month Closure Success 376/387 (97.2%) 154/154 (100%) (-0.068, +0.003)
12-month Closure Success 326/331 (98.5%) 149/149 (100%) (-0.052, 0.017)
Principal Safety Measures
Major Adverse Events 12-months 7/442 (1.6%) 8/154 (5.2%) (-0.090, -0.002
Minor Adverse Events 12-months 27/442 (6.1%) 29/154 (18.8%) (-0.200, -0.070)
12-month Composite Success (K-M) 0.934 0.938 [-0.044, +0.036]
Survival at 30 days (K-M) 0.939 0.956 [-0.052, +0.036]
Survival at 180 days (K-M) 0.936 0.947 [-0.048, +0.026]
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10
Registry Group – Fenestrated Fontan
Table 6. Principal Effectiveness and Safety Results – Patient Age Less Than 20 Years
AMPLATZER™
Patients Surgical Control Patients 90% Confidence Interval
Technical Success 315/328 (96.0%) 149/149 (100%) (-0.086, -0.005)
Procedure Success 306/315 (97.1%) 149/149 (100%) (0.074, +0.005)
Early (30 days) Composite Success 295/328 (89.9%) 143/149 (95.9%) (-0.124, -0.007)
12-month Composite Success 256/281 (91.1%) 142/149 (95.3%) (-0.108, +0.013)
24-hour Closure Success 301/310 (97.1%) 149/149 (100%) (-0.075, +0.005)
6-month Closure Success 270/278 (97.1%) 149/149 (100%) (-0.077, +0.006)
12-month Closure Success 246/251 (98.0%) 149/149 (100%) (-0.068, +0.014)
Principal Safety Measures
Major Adverse Events 12-months 6/328 (1.8%) 7/149 (4.7%) (-0.086, +0.008
Minor Adverse Events 12-months 16/328 (4.9%) 29/149 (19.5%) (-0.221, -0.085)
12-month Composite Success (K-M) 0.930 0.944 [-0.055, +0.027]
Survival at 30 days (K-M) 0.933 0.954 [-0.059, +0.017]
Survival at 180 days (K-M) 0.930 0.954 [-0.062, +0.014]
Table 7. Principal Efficacy Results – Fenestrated Fontan
AMPLATZER™
Patients
Upper 95%
Confidence
Bound
Technical Success 46/48 (95.8%) 0.875
Procedure Success 46/46 (100%) 0.937
Early Composite Success 44/48 (91.7%) 0.819
6-month Success 38/38 (100%) 0.924
Primary Efficacy Outcome (12-month Success) 32/32 (100%) 0.911
Hospital Days Mean ± s.d.(N) 1.2±0.7 (39) (0.95, 1.41)
[range] [0.0, 4.0]
Table 8. Principal Efficacy Results – Fenestrated Fontan
AMPLATZER™
Patientsa
a. Unit of analysis = Patient.
Upper 95%
Confidence
Bound
Major Adverse Events 2/48 (4.2%) 0.125
Minor Adverse Events 2/48 (4.2%) 0.125
Total Adverse Events 4/48 (8.3%) 0.181
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Directions for Use
Materials recommended for use with the device
• The AMPLATZER™ 45° Delivery System or the AMPLATZER™ TorqVue™ 45° Delivery
System (both sold separately) is recommended for use with the AMPLATZER™ Septal
Occluder.
• 0.035-inch exchange-length J-tip guidewire
• AMPLATZER™ Sizing Balloon II
Preprocedure Care
It is recommended that at least 24 hours prior to the procedure that the patient receives aspirin
(81 mg or 325 mg) or an alternative antiplatelet/anticoagulant if the patient has an aspirin
intolerance.
Procedure
1. Prepare the patient for a standard transcatheter procedure. Maintain a recommended
activated clotting time (ACT) of greater than 200 seconds. Effective anticoagulation
therapy should be maintained during and after the procedure as determined by the
physician.
2. Puncture the femoral vein and perform a standard right-heart catheterization.
3. Perform an angiogram to demonstrate the atrial defect. Catheterize the left atrium using a
45º LAO position and cranial angulation of 35º–45º. Inject contrast medium into the right
upper lobe pulmonary vein.
Note: Occluder size and placement are based on the locations of the defects.
4. Use the J-tip guidewire to gain access to the left atrium.
5. Echo guidance: The procedure should be performed under echo guidance to allow for
comprehensive assessment of all rims (with specific emphasis on adequacy of the
anterior-superior rim) and cardiac structures to enable appropriate placement and
position of the ASD device, and to assess whether acute ASD closure has been achieved
without pathologic interference or impingement on important surrounding cardiac
structures. Use echocardiographic measurements and an AMPLATZER™ Sizing
Balloon II to determine the diameter of the defect. Refer to the instructions for use
included with the AMPLATZER™ Sizing Balloon II for more information.
Note: If balloon sizing is performed in addition to echocardiographic measurements, a
stop-flow technique should be used.
6. Insert a compliant balloon catheter over the guidewire into the left atrium and determine
the diameter of the defect.
- Under fluoroscopic and echocardiographic guidance, place the balloon catheter across
the defect and inflate the balloon with diluted contrast medium until the left-to-right
shunt ceases.
- Deflate the balloon until flow is visible, and then reinflate the balloon until the shunting
ceases.
WARNING: Do not inflate the balloon beyond the stop-flow point or beyond the balloon's
maximum inflation volume. Inflation beyond the stop-flow point may cause distention of
the defect (resulting in inaccurate sizing of the defect) and/or balloon damage.
Note: A waist in the balloon could appear without the cessation of flow. This would occur if
there is more than one ASD. Sizing should occur based on stop-flow, not the appearance
of a waist.
- Measure the defect using echocardiographic imaging, fluoroscopy, or by using the
AMPLATZER™ Sizing Plate.
7. Once the diameter of the defect is determined, select a device size equal to or 1 size
larger than the diameter of the defect. Refer to Table T1 on the foldout of the back cover.
WARNING: Do not select a device size that is more than 1.5 times the
echocardiographic-derived ASD diameter prior to balloon sizing.
8. Remove the balloon catheter and leave the guidewire in place.
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9. Select the appropriate delivery system for the device size (see Table T1).
10. Prepare the delivery system for use according to the manufacturer’s instructions for use.
11. Insert the dilator into the delivery sheath and tighten the rotating luer. Advance the dilator
and delivery sheath over the guidewire, through the defect, and into the left upper
pulmonary vein. Verify the correct position of the sheath by a test hand injection of
contrast medium or by echocardiography.
CAUTION: Do not advance the delivery system if resistance is felt.
12. Attach the hemostasis valve to the proximal end of the loader and flush with sterile saline.
Slowly remove the dilator to prevent ingress of air. Allow blood backflow to purge all air
from the system.
13. Slowly remove the guidewire and flush the delivery sheath with sterile saline.
14. Prepare the device for use
- Inspect the sterile pouch and verify that it is unopened and undamaged. Do not use the
device if the sterile barrier is open or damaged.
- Gently open the sterile pouch.
15. Advance the delivery cable through the hemostasis valve and loader.
16. Attach the device to the distal end of the delivery cable by rotating the device clockwise
approximately 5 turns until the device is secure. Then rotate the device counterclockwise
1/8 of one turn to facilitate release of the device.
17. Immerse the device and loader in sterile saline and pull back on the delivery cable to
retract the device inside the loader.
18. Attach the loader to the delivery sheath and tighten the rotating luer to lock the
components together.
CAUTION: Attach the loader firmly to the sheath to ensure that there are no gaps
between the inner surfaces of the 2 components.
19. Advance the delivery cable and device through the delivery sheath until the device
reaches the tip of the delivery sheath. Do not rotate the delivery cable.
CAUTION: Do not advance the delivery cable and device if resistance is felt.
20. Use angiography and echocardiography for guidance. Hold the delivery cable in place
while retracting the delivery sheath to deploy the left atrial disc and part of the connecting
waist. Pull the device gently against the atrial septum. This can be felt and observed by
echocardiography.
21. Maintain a slight tension on the delivery cable while retracting the delivery sheath
approximately 5–10 cm to deploy the right atrial disc.
22. Use angiography and echocardiography to confirm that the device is in place and to
evaluate for residual shunt or valve insufficiency.
CAUTION: Do not release the device from the delivery cable if the device does not
conform to its original configuration or if device position is unstable or interferes with any
adjacent cardiac structure (such as SVC, PV, MV, CS, AO). Advance the delivery sheath
to recapture the device and redeploy. If the device position is still unsatisfactory, recapture
the device and replace it with a new device or abort the procedure.
23. Use imaging to verify correct position of the device.
24. When the device placement is confirmed the device may be released.
- Detach the device by turning the plastic vise counterclockwise.
Note: In the unlikely event that device detachment is not possible, advance the delivery
sheath against the right atrial disc to secure the device and to facilitate detachment.
- Remove the delivery cable and delivery sheath from the patient.
Post-Procedure Instructions
• All patients should be kept overnight for observation. A transthoracic echocardiogram should
be performed before discharge.
100092311_ASD.book Page 12 Monday, January 6, 2014 11:00 AM

13
• Patients with any observed pericardial effusion following the device implantation should be
closely monitored with serial echocardiogram performed until the pericardial effusion
resolves.
• Even though there are no known clinical or imaging predictors of patients at risk of erosion,
physicians should monitor high risk patients and use their clinical discretion on the frequency
of follow up and requirement for echocardiographic examinations.
- For these high risk patients monitoring is suggested at implant, 1 day post-implant, pre-
discharge, and again at 1 week, 1 month, 6 months, and 12 months post-implant.
Clinical follow up with a cardiologist annually thereafter is also recommended for the
high risk patients.
- Patients should be educated to seek immediate medical attention that includes an
echocardiogram, if they develop signs or symptoms of hemodynamic instability such as
chest pain, arrhythmia, fainting, or shortness of breath.
- Patients should be instructed to avoid strenuous activity for a minimum of 1 month post-
device implant or as directed by their physician. Strenuous activities may lead to the
increased risk of adverse events including erosion. Patients should be reminded that if
they experience any symptoms of shortness of breath or chest pain at any time, and
especially after strenuous activity, they should seek medical care immediately.
• Patients should take appropriate endocarditis prophylaxis for 6 months following device
implantation. The decision to continue endocarditis prophylaxis beyond 6 months is at the
discretion of the physician.
• Patients should be treated with antiplatelet/anticoagulation therapy (such as aspirin) for 6
months post-implant. The decision to continue antiplatelet/anticoagulation therapy beyond 6
months is at the discretion of the physician.
• Go to www.amplatzer.com/tempIDcard to print the temporary patient identification card.
Complete this card and give it to the patient.
• If the patient would like to receive a permanent patient identification card, complete the
implant registration form and send the completed form to AGA Medical.
Disposal
• The carton and instructions for use are recyclable. Dispose of all packaging materials as
appropriate.
• Devices may be returned to AGA Medical for disposal. Contact your AGA Medical
representative or [e-mail] for instructions.
• Devices may be disposed of following standard solid biohazard waste procedures.
Warranty
AGA Medical Corporation warrants to buyer that, for a period equal to the validated shelf life of the
product, this product shall meet the product specifications established by the manufacturer when
used in accordance with the manufacturer's instructions for use and shall be free from defects in
materials and workmanship. AGA Medical Corporation's obligation under this warranty is limited to
replacing or repairing at its option, at its factory, this product if returned within the warranty period
to AGA Medical Corporation and after confirmed to be defective by the manufacturer.
EXCEPT AS EXPRESSLY PROVIDED IN THIS WARRANTY, AGA MEDICAL CORPORATION
DISCLAIMS ANY REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED,
INCLUDING ANY WARRANTY AS TO MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE.
See the Terms and Conditions of Sale for further information.
For Australia Only
This warranty is given by St. Jude Medical (SJM). To make inquiries regarding this warranty, use
the contact information for either the manufacturer or Australian Sponsor located on the back
cover.
Our goods come with guarantees that cannot be excluded under the Australian Consumer Law.
You are entitled to a replacement or refund for a major failure and compensation for any other rea-
100092311_ASD.book Page 13 Monday, January 6, 2014 11:00 AM

14
sonably foreseeable loss or damage. You are also entitled to have the goods repaired or replaced
if the goods fail to be of acceptable quality and the failure does not amount to a major failure.
The benefits to you given by this warranty are in addition to your other rights and remedies under
the Australian Consumer Law.
SJM warrants to the buyer that the goods, for a period equal to the validated shelf life of the goods
(the "Warranty Period"), shall meet the product specifications established by the manufacturer
when used in accordance with the manufacturer's instructions for use and shall be free from
defects in materials and workmanship. Unless otherwise obligated by law or mandatory consumer
guarantees, under this warranty SJM will, at its option, replace or repair the goods at its factory, if
the buyer, at the buyer's expense, returns the goods within the Warranty Period to SJM to the
address below and after SJM confirms that the goods are defective.
SJM Amplatzer Products
Product Surveillance Lab
14901 DeVeau Place
Minnetonka, MN
55345-2126 USA
Tel: [phone]
To the maximum extent permitted by law, if a mandatory term is implied by law or a mandatory
consumer guarantee applies to the goods, and the goods are not of a kind ordinarily acquired for
personal, domestic or household use or consumption, SJM’s liability for the breach of the term or
guarantee is limited to, at SJM’s option, either replacement or repair of the goods or payment of
the costs of replacing or repairing the goods.
EXCEPT FOR MANDATORY TERMS IMPLIED BY LAW, MANDATORY CONSUMER GUARAN-
TEES, OR AS EXPRESSLY PROVIDED IN THIS WARRANTY, ST. JUDE MEDICAL DISCLAIMS
ANY REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED. See the
Terms and Conditions of Sale for further information.
100092311_ASD.book Page 14 Monday, January 6, 2014 11:00 AM

ABCD
mm mm mm mm Fr mm
(inch) mm (inch) cm
9-ASD-004 4 16 12 3
9-ITV06F45/60 6 2.11
(0.083)
2.79
(0.110) 609-ASD-005 5 17 13 3
9-ASD-006 6 18 14 3
9-ASD-007 7 19 15 3
9-DEL-6F-45/60 6 2.11
(0.083)
2.72
(0.107) 60
9-ASD-008 8 20 16 3
9-ASD-009 9 21 17 3
9-ASD-010 10 22 18 3
9-ASD-011 11 25 21 4 9-ITV07F45/60 7 2.44
(0.096)
3.18
(0.125) 60
9-ASD-012 12 26 22 4
9-ASD-013 13 27 23 4 9-ITV07F45/80 7 2.44
(0.096)
3.18
(0.125) 80
9-ASD-014 14 28 24 4
9-ASD-015 15 29 25 4 9-DEL-7F-45/60 7 2.44
(0.096)
3.05
(0.120) 60
9-ASD-016 16 30 26 4
9-ASD-017 17 31 27 4 9-DEL-7F-45/80 7 2.44
(0.096)
3.05
(0.120) 80
Device and delivery system dimensions (sold separately) / Размери на устройството
исистемата за въвеждане (продават се отделно) / Dimenzije uređaja i uvodnog
sistema (prodaju se zasebno) / Rozměry zařízení a zaváděcího systému (prodává se
samostatně) / Anoordningens og indføringssystemets dimensioner (sælges separat) /
Abmessungen des Produkts und des Einführsystems (separat erhältlich) / ∆ιαστάσεις
συσκευής και συστήματος προώθησης (πωλούνται ξεχωριστά) / Device and delivery
system dimensions (sold separately) / Seadme ja paigaldussüsteemi mõõtmed
(müüakse eraldi) / Laitteen ja sisäänviejäjärjestelmän mitat (myydään erikseen) /
Dimensions du dispositif et du système de pose (vendus séparément) / Dimenzije
umetka i uvodnog sustava (prodaje se zasebno) / Az eszköz és a (külön kapható)
bevezetőrendszer méretei / Dimensioni del dispositivo e del sistema di introduzione
(venduti separatamente) / 기기 및 전달 시스템 치수(별매) / Įtaiso ir įvedimo sistemos
matmenys (parduodama atskirai) / Ierīces un ievadīšanas sistēmas izmēri
(iegādājamas atsevišķi) / Afmetingen van apparaat en plaatsingssysteem
(afzonderlijk verkocht) / Dimensjoner på enhetog innføringssystem (selges separat) /
Wymiary urządzenia i systemu wprowadzającego (sprzedawanego oddzielnie) /
Dimensões do sistema introdutor e do dispositivo (vendidos separadamente) /
Dimensiunile dispozitivului şi sistemului de aplicare (vândute separat) / Размеры
устройства идоставочной системы (приобретаются раздельно) / Rozmery
zariadenia a zavádzacieho systému (predávané samostatne) / Mere pripomočka in
uvajalnega sistema (se prodajata ločeno) / Përmasat e pajisjes dhe sistemit të
vendosjes (të shitura veçmas) / Dimenzije uređaja i dopremnog sistema (prodaju se
zasebno) / Anordningens och tillförselsystemets dimensioner (säljs separat) / Cihaz
ve taşıma sistemi boyutları(ayrısatılır) / 器械和传送系统尺寸规格 （分开销售）/
T1
D
AB
C
100092311_ASD.book Page 230 Monday, January 6, 2014 11:00 AM