Bard COVERA PLUS User manual

Instructions for Use
Mode d'emploi · Gebrauchsanweisung · Istruzioni per l'uso · Instrucciones de uso · Gebruiksaanwijzing ·
Instruções de Utilização · Οδηγίες χρήσης · Brugsanvisning · Bruksanvisning · Käyttöohjeet ·
Bruksanvisning · Instrukcja użycia · Használati útmutató · Návod k použití · Kullanım Yönergeleri ·
ḽ䏦奨㓌 · ۉࡅ ৗ · Инструкция по применению · Navodila za uporabo · Upute za uporabu ·
Инструкции за употреба · :ϡ΍ΩΧΗγϻ΍ΕΎϣϳϠόΗ
B05884 Rev.2/05-18
Endoprothèse vasculaire couverte · Beschichteter Gefäßstent · Stent coperto vascolare · Stent vascular recubierto ·
Beklede vasculaire stent · Stent vascular coberto · Αγγειακό καλυμμένο στεντ · Beklædt, vaskulær stent ·
Täckt vaskulär stent · Pinnoitettu vaskulaaristentti · Vaskulær tildekket stent · Powlekany stent naczyniowy ·
Fedett vaszkuláris sztent · Potažený cévní stent · Kaplı Vasküler Stent · 图䩟塄做㏭㙴 · ୁ˔଑տ୆ݘચ ·
Сосудистый стент с покрытием · Prekrita žilna opornica · Vaskularni pokriveni stent ·
съдовия покрит стент · ΓΎρϐϣΔϳ΋ΎϋϭΔϣΎϋΩ

2
Table of Contents
Table des matières tInhaltsverzeichnis tSommario tÍndice tInhoud tÍndice tΠίνακας Περιεχομένων tIndhold t
Innehållsförteckning tSisällysluettelo tInnholdsfortegnelse tSpis treści tTartalom tObsah tİçindekiler t
䖬懂 tֹ tСодержание tKazalo vsebine tSadržaj tСъдържание tΕΎϳϭΗΣϣϟ΍ ϝϭΩΟ
English. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .03
Français. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .08
Deutsch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Italiano . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Español . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
Nederlands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
Português . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Eλληνικά . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
Dansk. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Svenska. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Suomi. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Norsk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58
Polski . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Magyar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68
Čeština. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Türkçe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .78
䳿榒ᳫ㑅. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
ଞ˲߭ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88
Русский. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93
Slovensčina. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98
Hrvatski. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103
Български . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .108
ΔϳΑέόϟ΍. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .113

3
English
DEVICE DESCRIPTION
IMPLANT
The COVERA™ PLUS Vascular Covered Stent is a highly flexible, self-expanding endoprosthesis comprised of expanded
polytetrafluoroethylene (ePTFE) encapsulating a nitinol (nickel-titanium) stent framework. The inner lumen of the covered stent
(blood contact surface) is carbon impregnated.
The COVERA™ PLUS Vascular Covered Stent is available in a variety of diameters and lengths.
Figure 1: Covered Stent Implant
XRAY MARKERS
Highly radiopaque ePTFE encapsulated tantalum markers are evenly distributed around the circumference of the proximal and
distal ends of the covered stent.
DELIVERY SYSTEM
The delivery system is illustrated in Figure 2. The inner catheter (not visible to the operator) contains the guidewire lumen.
The inner catheter carries an atraumatic tip (A) at the distal end of the system and enters into a female Luer connection (B) at
the proximal end of the handle. A proximal white stability sheath (C) is connected to the distal end of the handle and remains
stationary throughout the deployment process.
The distal catheter assembly (30 cm in length) consists of two segments: the transparent covered stent delivery sheath (D),
housing the compressed covered stent (implant); and a darker brown, smaller diameter extension catheter (E). During covered
stent deployment, the entire distal catheter assembly retracts towards the handle while the dark catheter segment is drawn
inside the white stability sheath until the covered stent is fully deployed.
Retraction of the distal catheter and deployment of the covered stent is initiated by rotating the large wheel (G) on the handle.
The large deployment wheel is used for the initiation of deployment and a slower deployment rate whereas the small deployment
wheel (H) may be used for faster deployment after initiation.
Figure 2: Itemized Drawing of the COVERA™ PLUS Vascular Covered Stent Delivery System
A red safety lock (F) on the handle prevents premature release of the covered stent. Prior to covered stent deployment, the safety
lock must be retracted from the locked position into the unlocked position (Figure 3).
Figure 3: Handle Top View
1 = Red Safety Lock (F)
2 = Large DeploymentWheel for initial and slow deployment (G)
3 = Small DeploymentWheel for faster deployment (H)
Legend for Figures 2 & 3
Reference Corresponding Information
A Delivery System Tip
B Female Luer Port
C Proximal Stability Sheath (white, stationary)
DDistal Catheter Sheath Segment (transparent, retracts during deployment) housing the Compressed
Covered Stent
E Distal Catheter Sheath Segment (dark brown, retracts during deployment)
F Red Safety Lock
G Large DeploymentWheel (initial and slow deployment)
H Small DeploymentWheel (fast deployment)
The COVERA™ PLUS Vascular Covered Stent device is an over-the-wire delivery system. The delivery system is compatible with
0.035 inch (0.89 mm) guidewires and 8F or 9F introducer sheaths. The delivery system is available in working lengths of 80 cm
and 120 cm.
INDICATION FOR USE
The COVERA™ PLUS Vascular Covered Stent is indicated for the treatment of stenoses in the upper extremity venous outflow of
patients dialyzing with an arterio-venous (AV) access graft or fistula and for the treatment of atherosclerotic lesions in iliac and
femoral arteries with a reference vessel diameter of 4.5 mm to 9 mm.
CONTRAINDICATIONS
There are no known contraindications for the COVERA™ PLUS Vascular Covered Stent.
WARNINGS
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associated with dialysis access shunt revisions and endovascular procedures.
t DO NOT expose the covered stent to temperatures higher than 680 °F (360 °C). ePTFE decomposes at elevated temperatures,
producing highly toxic decomposition byproducts.
t DO NOT use the device if packaging/pouch is damaged.
t DO NOT use the device after the "Use By" date specified on the label.
t 5IF COVERA™ PLUS Vascular Covered Stent device is supplied STERILE and is intended for SINGLE USE ONLY. DO NOT
RESTERILIZE AND/OR REUSE the device.
Reuse, resterilization, reprocessing and/or repackaging may create a risk to the patient or user, may lead to infection or
compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to
device failure, and/or lead to injury, illness, or death of the patient.

4
SPECIFIC AV ACCESS RELATED PRECAUTIONS
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t 5IFTBGFUZBOEFGGFDUJWFOFTTPGUIFEFWJDFXIFOQMBDFEBDSPTTUIFBOUFDVCJUBMGPTTBIBTOPUCFFOFWBMVBUFE
t 5IFFGGFDUTPGEJSFDUDBOOVMBUJPOPGUIFDPWFSFETUFOUIBWFOPUCFFOFWBMVBUFE/PUJGZUIFQBUJFOUUIBUUIFDPWFSFETUFOUTIPVME
not be directly cannulated for hemodialysis and that applying pressure to the implant area should be avoided.
POTENTIAL COMPLICATIONS AND ADVERSE EVENTS
Complications and Adverse Events associated with the use of the COVERA™ PLUS Vascular Covered Stent may include the usual
complications associated with endovascular stent and covered stent placement and dialysis shunt revisions.
Potential complications may include, but are not limited to:
Abscess; access site infection; allergic/anaphylactoid reaction; amputation; aneurysm; angina/coronary ischemia; arteriovenous
fistula; arrhythmia; bleeding at access site; bypass surgery; cerebrovascular accident; congestive heart failure; embolization;
extravasation; fever; hematoma; hemorrhage; hemoptysis; hypotension/hypertension; intimal injury/dissection; ischemia/
infarction of tissue/organ; infection; myocardial infarction; occlusion; pain; pulmonary embolism; perforation; prolonged
bleeding; pseudoaneurysm; rash; reaction to contrast; renal failure; renal toxicity; radiation injury; restenosis; septicemia/
bacteremia; sepsis; stroke; thrombus; vasospasm; ventricular fibrillation; vessel rupture and death.
AV Access specific adverse events may include, but are not limited to:
Arm or hand edema; steal syndrome; and face or neck edema.
Covered stent specific events that could be associated with clinical complications include, but are not limited to:
Embolism; fracture; insufficient covered stent expansion; kinking; malapposition; migration and misplacement; and side branch
occlusion.
Delivery System specific events that could be associated with clinical complications include, but are not limited to:
Blood leakage from delivery system; bond joint failures; delivery system kinking; detachment of parts; failure to deploy; high
deployment forces; inability to track to target location; inaccurate deployment; incompatibility with accessory devices; no
visibility under fluoroscopy; and premature deployment.
COVERED STENT SIZE SELECTION
Special care must be taken to ensure that an appropriately sized device is selected. In the case of a diameter difference between
the inflow and the outflow end, always use the inflow vessel or AV graft diameter as the reference vessel diameter.
Table 1: Covered Stent Diameter Selection
Covered Stent Diameter Recommended Oversizing Reference Vessel Diameter
6 mm 0.5 mm – 1.5 mm 4.5 mm – 5.5 mm
7 mm 0.5 mm – 1.5 mm 5.5 mm – 6.5 mm
8 mm 1 mm – 2 mm 6 mm – 7 mm
9 mm 1 mm – 2 mm 7 mm – 8 mm
10 mm 1 mm – 2 mm 8 mm – 9 mm
Covered Stent Length
Ensure the selected covered stent length covers the entire lesion and both ends of the implant extend at least 5 mm into the non-
diseased segment of the vessel. In the case of overlapping devices, at least 10 mm of overlap between devices is recommended.
For covered stent placements in the proximal cephalic arch, select the length so that the ostial lesion is fully covered and so that
the proximal covered stent end does not compromise the flow in the axillary/subclavian vein. Ensure that the covered stent end
extends at least 10 mm beyond the arch curvature into the straight distal cephalic vein segment.
NOTE: The COVERA™ PLUS Vascular Covered Stent foreshortening is ≤ 13%.
Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long
and small lumina, joints, and/or crevices between components – are difficult or impossible to clean once body fluids or tissues
with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period
of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms
which may lead to infectious complications or death.
t DO NOT use in patients with uncorrectable coagulation disorders.
t DO NOT use in patients that cannot be adequately pre-medicated.
t DO NOT use in patients who have a known allergy or sensitivity to contrast media.
t DO NOT use in patients with known hypersensitivity to nickel-titanium or tantalum.
t DO NOT use the device in patients where full expansion of an appropriately sized PTA balloon catheter could not be achieved
during pre-dilation with an angioplasty balloon.
t DO NOT use in patients who cannot receive recommended antiplatelet and/or anticoagulation therapy.
t DO NOT use in patients with functionally relevant arterial obstruction of the inflow path, poor outflow or no distal runoff.
t DO NOT place in patients with a target lesion with a large amount of adjacent acute or subacute thrombus.
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t DO NOT use for the treatment of lesions that would prevent a surgical salvage bypass procedure.
t DO NOT track and deploy the 9F endovascular system across the aorto-iliac bifurcation in crossover fashion since this may
result in failure to deploy the covered stent.
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SPECIFIC AV ACCESS RELATED WARNINGS
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t DO NOT use in patients whose AV access grafts have been implanted for less than 30 days or in an immature fistula.
t $PWFSFETUFOUQMBDFNFOUCFZPOEUIFPTUJVNPGUIFDFQIBMJDWFJOJOUPUIFBYJMMBSZTVCDMBWJBOWFJONBZIJOEFSPSQSFWFOUGVUVSF
access.
t DO NOT use in patients with bacteremia or septicaemia and/or evidence of fistula or graft infection.
PRECAUTIONS
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t %VSJOHEFWJDFQMBDFNFOUTJODSPTTPWFSUFDIOJRVFNBJOUBJOUIFQSPYJNBMDPWFSFETUFOUFOEJOBTUSBJHIUQPTJUJPOUISPVHIPVU
deployment.
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t 0ODFQBSUJBMMZPSGVMMZEFQMPZFEUIFDPWFSFETUFOUDBOOPUCFSFUSBDUFEPSSFNPVOUFEPOUPUIFEFMJWFSZTZTUFN
t *GVOVTVBMSFTJTUBODFJTNFUEVSJOHDPWFSFETUFOUTZTUFNJOUSPEVDUJPOUIFTZTUFNTIPVMECFSFNPWFEBOEBOPUIFSDPWFSFE
stent system should be used.
t DO NOT introduce or manipulate the delivery system without an appropriately sized guidewire and without fluoroscopic
guidance.
t DO NOT use a kinked delivery system.
t 'PSDPOUSBMBUFSBMQSPDFEVSFTBMPOHDSPTTPWFSJOUSPEVDFSTIFBUIPSHVJEJOHDBUIFUFSNVTU CF QMBDFE BDSPTTUIFBPSUPJMJBD
bifurcation. Make sure that the proximal covered stent end is positioned in a straight section of the vessel during deployment.
t %VSJOHDPWFSFETUFOUSFMFBTF DO NOT hold the 30 cm long distal catheter assembly segment as it must be free to move and
slide into the white stability sheath.
t $BSFGVMBUUFOUJPOCZUIFPQFSBUPSJTXBSSBOUFE UP NJUJHBUFUIFQPUFOUJBMGPSEJTUBMNJHSBUJPOPG UIFDPWFSFETUFOUEVSJOH
deployment.
t 5IFDPWFSFETUFOUDBOOPUCFQPTUEJMBUFECFZPOEJUTMBCFMMFEEJBNFUFS
t 5IFTBGFUZBOEFGGFDUJWFOFTTPGUIFEFWJDFXIFOQMBDFEBDSPTTBOBOFVSZTNPSBQTFVEPBOFVSZTNIBTOPUCFFOFWBMVBUFE
t 5IFTBGFUZBOEFGGFDUJWFOFTTPGUIFEFWJDFXIFOQMBDFEBDSPTTBQSFWJPVTMZQMBDFECBSFNFUBMTUFOUIBTOPUCFFOFWBMVBUFE
t 5IFTBGFUZBOEFGGFDUJWFOFTTPGUIFEFWJDFXIFOQMBDFEJOUIFQPQMJUFBMBSUFSZIBTOPUCFFOFWBMVBUFE
t 5IFTBGFUZBOEFGGFDUJWFOFTTPGUIFEFWJDFXIFOVTFEJOQFEJBUSJDTIBTOPUCFFOFWBMVBUFE
t 5IFEFWJDF IBTOPUCFFOUFTUFEGPSVTFJOBOPWFSMBQQFEDPOEJUJPOXJUIB CBSFNFUBMTUFOUPSDPWFSFETUFOUTGSPNPUIFS
manufacturers.
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5
MATERIALS REQUIRED FOR THE COVERA™ PLUS VASCULAR COVERED STENT PROCEDURE
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t $POUSBTUNFEJVN
t JODINNHVJEFXJSFPGBQQSPQSJBUFMFOHUIUPBMMPXTBGFEFMJWFSZPGUIFDPWFSFETUFOUBOESFNPWBMPGUIFEFMJWFSZ
system
t *OUSPEVDFSTIFBUIXJUIBQQSPQSJBUFJOOFSEJBNFUFSBOEMFOHUI
t %JBHOPTUJDDBUIFUFSTBOEBDDFTTPSJFT
t #BMMPPOBOHJPQMBTUZDBUIFUFSGPSQSFBOEPSQPTUEJMBUJPO
t *OGMBUJPOEFWJDF
INSTRUCTIONS FOR USE
Preparation
1. After removal from the packaging, verify that the safety lock is in the locked position.
NOTE:
After reading, tear off the paper hang tag with the safety notes from the handle of the 9F endovascular system.
2. Using standard endovascular access techniques and fluoroscopy, access the target vessel from a site that permits the
straightest possible path to the target lesion and advance an 0.035 inch (0.89 mm) guidewire across the target lesion.
3. For contralateral procedures, a long crossover introducer sheath or guiding catheter must be placed across the aortoiliac
bifurcation.
4. Pre-dilate the stenosis with a PTA balloon catheter of appropriate length and diameter for the lesion to be treated.
5. Select the appropriate covered stent diameter based on the sizing table (Table 1).
6. Examine the packaging and delivery system to determine whether there is any damage or whether the sterile barrier has
been compromised. Do not use the device if any of these conditions are observed.
7. Flush the delivery system through the Luer port at the proximal end of the handle with sterile saline until saline drops from
the tip of the system (Figure 4).
Figure 4
NOTE: Do not retract the red safety lock until the covered stent is positioned across the lesion and ready to be
deployed.
Delivery System Introduction
8. Under radiographic guidance, advance the delivery system over the guidewire past the target lesion and then pull back
slightly on the entire system to attain correct positioning of the radiopaque markers. Use the radiopaque covered stent ends
to center the covered stent across the lesion (Figure 5).
Figure 5
MAGNETIC RESONANCE IMAGING MRI COMPATIBILITY
Non-clinical testing has demonstrated that the COVERA™ PLUS Vascular Covered Stent is MR Conditional for the placement of
a single covered stent in the vessels of the arm and placement of a single covered stent or overlapped covered stents in the
iliac and superficial femoral arteries for all clinically relevant lengths. Based upon the preclinical testing, patients with the
COVERA™ PLUS Vascular Covered Stent can be safely scanned, immediately after placement of this implant, under the following
conditions:
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t /PSNBMNPEFPQFSBUJPOPGUIF.3TZTUFN
3.0 Tesla Temperature Rise
In an analysis based on non-clinical testing according to ASTM F2182-11a and computer modeling of a patient, the single
6 x 100 mm COVERA™ PLUS Vascular Covered Stent was determined to produce a potential worst-case temperature rise of less than
3 °C at a whole body SAR of 1 W/kg for 15 minutes of MR scanning in a 3.0Tesla, whole body MR system. Cooling due to blood
flow inside the covered stent and perfusion in the vascular bed surrounding the covered stent was included in the assessment of
in-vivo temperature rise.
1.5 Tesla Temperature Rise
In an analysis based on non-clinical testing according to ASTM F2182-11a and computer modeling of a patient, the single
6 x 100 mm COVERA™ PLUS Vascular Covered Stent was determined to produce a potential worst-case temperature rise of less than
3 °C at the whole body SAR of 1 W/kg for 15 minutes of MR scanning in a 1.5 Tesla, whole body MR system. Cooling due to blood
flow inside the covered stent and perfusion in the vascular bed surrounding the covered stent was included in the assessment of
in-vivo temperature rise.
Image Artifact
Artifact tests were performed according to ASTM F2119-07. 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 covered stent. Maximum artifact extended 5.5mm beyond the covered
stent for the spin echo sequence and 5.5mm for the gradient echo sequence.The lumen was obscured.
Additional Information
Good clinical MR practice should be followed, including placement of padding between the bore wall and the patient and
avoiding contact between the hands and the body.
The COVERA™ PLUS Vascular Covered Stent has not been evaluated in MRI systems with field strengths other than 1.5 or 3.0 Tesla.
The heating effect in the MRI environment for fractured covered stents is not known. The presence of other implants or the health
state of the patient may require reduction of the MRI limits listed above.
HOW SUPPLIED
The COVERA™ PLUS Vascular Covered Stent is supplied sterile (by ethylene oxide gas). For single use only.
STORAGE
Store in a cool, dry place. Keep away from sunlight. DO NOT use the device after the“Use By”date specified on the label.
DISPOSAL INSTRUCTIONS
After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and
applicable local, state and federal laws and regulations.
CLINICAL USE INFORMATION
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t "DDPSEJOHUPQVCMJTIFEDMJOJDBMMJUFSBUVSFBCPVUTJNJMBSTFMGFYQBOEJOHDPWFSFETUFOUTUIFQSPQIZMBDUJDJOIJCJUJPOPGQMBUFMFU
aggregation should be considered when the device is placed in iliac or femoral arteries.
t 5IFCOVERA™ PLUS Vascular Covered Stent should be used only by physicians who are familiar with the complications, side
effects, and hazards commonly associated with dialysis access shunt revisions and endovascular procedures.

6
10. With your free hand, maintain a stationary hold on the white stability sheath during covered stent deployment and adjust
for placement accuracy if necessary (Figure 8). Hold the white stability sheath as close as possible to the introducer without
touching the dark brown moving catheter of the distal catheter assembly. Maintain the remainder of the white stability
sheath (segment between left and right hand on illustration) relaxed and avoid tension.
Figure 8
PRECAUTION:
During device placements in cross-over technique, maintain the proximal covered stent end in a straight position throughout
deployment.
IMPORTANT:
Do not touch the distal catheter assembly (i.e. the dark brown catheter segment) during covered stent
deployment since this may interfere with covered stent deployment and may lead to misplacement (Figure 9).
Figure 9
11. Slowly and carefully activate the stent release mechanism by rotating backwards the large wheel on the top of the handle.
NOTE: For accurate placement, subtle repositioning may be performed during initial wheel activation while
the covered stent is still compressed in the catheter.
After deployment of approximately 15 mm, wait several seconds to allow the distal end of the covered stent to fully expand.
Ensure the covered stent has wall apposition before completing deployment (Figure 10).
NOTE:
Ensure the selected covered stent length covers the entire lesion and both ends of the implant extend at least 5 mm into the non-
diseased segment of the vessel. In the case of overlapping devices, at least 10 mm of overlap between devices is recommended.
For covered stent placements in the proximal cephalic arch, select the length such that the ostial lesion is fully covered and that
the proximal covered stent end does not compromise the flow in the axillary/subclavian vein. Ensure that the covered stent end
extends at least 10 mm beyond the arch curvature into the straight distal cephalic vein segment.
PRECAUTION:
For contralateral procedures, a long crossover introducer sheath or guiding catheter must be placed across the aortoiliac
bifurcation. Make sure that the proximal covered stent end is positioned in a straight section of the vessel during deployment
(Figure 6).
WARNING:
DO NOT track and deploy the 9F endovascular system across the aorto-iliac bifurcation in crossover fashion since this may result
in failure to deploy the covered stent.
Figure 6
Covered Stent Deployment
9. Prior to covered stent deployment, unlock the red safety lock (Figure 7) by pressing it down and pulling it back towards the
end of the grip from the locked position into the unlocked position . Ensure that the red safety lock is completely
retracted and that the symbol for the unlocked position is fully visible.
Figure 7

7
Figure 10
12. Complete the covered stent deployment with either the large wheel (slow release) or switch to the small wheel for faster
release.
NOTE: Higher friction forces may occur with longer length covered stents.
13. Carefully remove the delivery system under fluoroscopy while maintaining guidewire access.
14. Post dilate the covered stent with an angioplasty balloon sized appropriately as to ensure complete wall apposition to the
reference vessel. Avoid balloon dilation in the healthy, non-stenosed segment of the vessel.
NOTE: It is recommended to advance the PTA balloon catheter through the deployed covered stent under
fluoroscopy to ensure that the covered stent remains well positioned.
15. Using standard procedures, verify location and patency of the covered stent.
PATIENT IMPLANT INFORMATION CARD
A Patient Implant Information Card is attached within this Instructions for Use. Carefully fold along the perforations and remove
the implant information card.
The patient, implant and hospital information should be recorded on the card. Ensure a peel-away sticker from the product label is
placed on the card before it is given to the patient.The sticker contains important information about the implant.
The patient should carry the implant information card with them and present it to any medical personnel involved in their care.

8
Français
DESCRIPTION DU DISPOSITIF
IMPLANT
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-hFOEPQSPUIÒTFWBTDVMBJSFDPVWFSUFCOVERA™ PLUSFTUEJTQPOJCMFFOEJGGÏSFOUTEJBNÒUSFTFUEJGGÏSFOUFTMPOHVFVST
Figure 1 : Endoprothèse couverte
MARQUEURS RADIOGRAPHIQUES
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SYSTÈME DE MISE EN PLACE
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EJTUBMFEFMBQPJHOÏFFUSFTUFGJYFUPVUBVMPOHEVQSPDFTTVTEFEÏQMPJFNFOU
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WFSTMBQPJHOÏFUBOEJTRVFMFTFHNFOUEFDBUIÏUFSGPODÏFTUBUUJSÏËMhJOUÏSJFVSEFMBHBJOFEFTUBCJMJTBUJPOCMBODIFKVTRVhËDFRVF
MhFOEPQSPUIÒTFDPVWFSUFTPJUFOUJÒSFNFOUEÏQMPZÏF
-BSÏUSBDUJPOEVDBUIÏUFSEJTUBMFUMFEÏQMPJFNFOUEFMhFOEPQSPUIÒTFDPVWFSUFTFEÏDMFODIFOUFOUPVSOBOUMBHSBOEFNPMFUUF(
TVSMBQPJHOÏF-BHSBOEFNPMFUUFEFEÏQMPJFNFOUTFSUËDPNNFODFSMFEÏQMPJFNFOUFUËEÏQMPZFSMhJNQMBOUËWJUFTTFSÏEVJUF
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de celui-ci.
Figure 2 : Dessin détaillé du système de mise en place de l'endoprothèse vasculaire couverte COVERA™ PLUS
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MFEÏQMPJFNFOUEFMhFOEPQSPUIÒTFDPVWFSUFJMFTUJNQÏSBUJGEFSÏUSBDUFSMFWFSSPVJMMBHFEFTÏDVSJUÏEFMBQPTJUJPOCMPRVÏF
ËMBQPTJUJPOEÏCMPRVÏF (Figure 3).
Figure 3 : Poignée vue de dessus
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-ÏHFOEFEFT'JHVSFTFU
Référence Informations correspondantes
A&NCPVUEVTZTUÒNFEFNJTFFOQMBDF
B Raccord Luer femelle
C Gaine de stabilisation proximale (blanche, fixe)
D4FHNFOUEFHBJOFEFDBUIÏUFSEJTUBMUSBOTQBSFOUTFSÏUSBDUFQFOEBOUMFEÏQMPJFNFOUDPOUFOBOU
MhFOEPQSPUIÒTFDPVWFSUFDPNQSJNÏF
E4FHNFOUEFHBJOFEFDBUIÏUFSEJTUBMNBSSPOGPODÏTFSÏUSBDUFMPSTEVEÏQMPJFNFOU
F7FSSPVJMMBHFEFTÏDVSJUÏSPVHF
G(SBOEFNPMFUUFEFEÏQMPJFNFOUEÏQMPJFNFOUJOJUJBMFUMFOU
H1FUJUFNPMFUUFEFEÏQMPJFNFOUEÏQMPJFNFOUSBQJEF
-hFOEPQSPUIÒTFWBTDVMBJSFDPVWFSUFCOVERA™ PLUSFTUBTTPDJÏFËVOTZTUÒNFEFNJTFFOQMBDFQBSGJMHVJEF-FTZTUÒNFEFNJTFFO
QMBDFFTUDPNQBUJCMFBWFDMFTGJMTHVJEFTEFJODINNFUMFTHBJOFTEhJOUSPEVDUJPOEF'PV'-FTZTUÒNFEFNJTFFO
place est disponible en longueurs de travail de 80cm et 120 cm.
INDICATIONS
-hFOEPQSPUIÒTFWBTDVMBJSFDPVWFSUFCOVERA™ PLUSFTUJOEJRVÏFQPVSMFUSBJUFNFOUEFTTUÏOPTFTEBOTMFEÏCJUWFJOFVYTPSUBOUEFT
FYUSÏNJUÏTTVQÏSJFVSFTEFTQBUJFOUTTPVTEJBMZTFQPSUFVSTEhVOHSFGGPOPVEhVOFGJTUVMFEhBCPSEBSUÏSJPWFJOFVY"7FUQPVSMF
USBJUFNFOUEFTMÏTJPOTBUIÏSPTDMÏSPUJRVFTEBOTMFTBSUÒSFTJMJBRVFTFUGÏNPSBMFTBWFDVOEJBNÒUSFEFWBJTTFBVEFSÏGÏSFODFEF
NNËNN
CONTREINDICATIONS
*MOhFYJTUFBVDVOFDPOUSFJOEJDBUJPODPOOVFËMhVUJMJTBUJPOEFMhFOEPQSPUIÒTFWBTDVMBJSFDPVWFSUFCOVERA™ PLUS.
MISES EN GARDE
t $FEJTQPTJUJGOFEPJUÐUSFVUJMJTÏRVFQBSEFTNÏEFDJOTRVJDPOOBJTTFOUMFTDPNQMJDBUJPOTMFTFGGFUTTFDPOEBJSFTFUMFTSJTRVFT
DPVSBNNFOUBTTPDJÏTBVYSÏWJTJPOTEFTIVOUEhBCPSEEFEJBMZTFFUBVYJOUFSWFOUJPOTFOEPWBTDVMBJSFT
t NE PAS FYQPTFSMhFOEPQSPUIÒTFDPVWFSUFËEFTUFNQÏSBUVSFTTVQÏSJFVSFTË¡'¡$-hF15'&TFEÏDPNQPTFËEFT
UFNQÏSBUVSFTÏMFWÏFTFUSFMÉDIFEFTQSPEVJUTEÏSJWÏTEFEÏDPNQPTJUJPOFYUSÐNFNFOUUPYJRVFT
t NE PASVUJMJTFSMFEJTQPTJUJGTJMhFNCBMMBHFPVMFTBDIFUTPOUFOEPNNBHÏT
t NE PASVUJMJTFSMFEJTQPTJUJGBQSÒTMBEBUFj®VUJMJTFSBWBOUxJOEJRVÏFTVSMÏUJRVFUUF
t -hFOEPQSPUIÒTFWBTDVMBJSFDPVWFSUF COVERA™ PLUS est fournie STÉRILE. Elle est À USAGE UNIQUE. NE PAS RESTÉRILISER
ET/OU RÉUTILISER ce dispositif.
 -BSÏVUJMJTBUJPOMBSFTUÏSJMJTBUJPOMFSFUSBJUFNFOUFUPVMFSFDPOEJUJPOOFNFOUQFVWFOUFOUSBÔOFSVOSJTRVFEhJOGFDUJPODIF[
MFTQBUJFOUTPVMhVUJMJTBUFVSDPNQSPNFUUSFMhJOUÏHSJUÏTUSVDUVSFMMFFUPVMFTDBSBDUÏSJTUJRVFTEFDPODFQUJPOFUEFNBUÏSJBVY
FTTFOUJFMMFTEVEJTQPTJUJGDFRVJQFVUDBVTFSMFEZTGPODUJPOOFNFOUEVEJTQPTJUJGFUPVFOUSBÔOFSEFTCMFTTVSFTNBMBEJFTPVMF
EÏDÒTEVQBUJFOU

9
t -BTÏDVSJUÏFUMhFGGJDBDJUÏEVEJTQPTJUJGNJTFOQMBDFEBOTMBSUÒSFQPQMJUÏFOhPOUQBTÏUÏÏWBMVÏFT
t -BTÏDVSJUÏFUMhFGGJDBDJUÏEVEJTQPTJUJGVUJMJTÏFOQÏEJBUSJFOhPOUQBTÏUÏÏWBMVÏFT
t -hVUJMJTBUJPOEVEJTQPTJUJGFODPOEJUJPOEFTVQFSQPTJUJPOBWFDVOTUFOUFONÏUBMOVPVEFTFOEPQSPUIÒTFTDPVWFSUFTEhBVUSFT
GBCSJDBOUTOhBQBTÏUÏUFTUÏF
t 6OFGPSDFEFEÏQMPJFNFOUQMVTJNQPSUBOUFQFVUÐUSFOÏDFTTBJSFBWFDMFTFOEPQSPUIÒTFTDPVWFSUFTEFQMVTHSBOEFMPOHVFVS
PRÉCAUTIONS SPÉCIFIQUES LIÉES À L'ABORD AV
t -BTÏDVSJUÏFUMhFGGJDBDJUÏEVEJTQPTJUJGVUJMJTÏEBOTMFTWFJOFTDFOUSBMFTOhPOUQBTÏUÏÏWBMVÏFT
t -BTÏDVSJUÏFUMhFGGJDBDJUÏEVEJTQPTJUJGNJTFOQMBDFEBOTMBGPTTFBOUÏDVCJUBMFOhPOUQBTÏUÏÏWBMVÏFT
t -FTFGGFUTEFMBDBOVMBUJPOEJSFDUFEFMhFOEPQSPUIÒTFDPVWFSUFOhPOUQBTÏUÏÏWBMVÏT*OEJRVFSBVQBUJFOURVFMhFOEPQSPUIÒTF
DPVWFSUFOFEPJUQBTÐUSFDBOVMÏFEJSFDUFNFOUQPVSMhIÏNPEJBMZTFFURVFMhBQQMJDBUJPOEhVOFQSFTTJPOEBOTMB[POFEFMhJNQMBOU
EPJUÐUSFÏWJUÏF
COMPLICATIONS ET EFFETS INDÉSIRABLES POTENTIELS
-FTDPNQMJDBUJPOTFUMFTFGGFUT JOEÏTJSBCMFTBTTPDJÏTËMhVUJMJTBUJPOEFMhFOEPQSPUIÒTFDPVWFSUFWBTDVMBJSFCOVERA™ PLUS peuvent
OPUBNNFOUDPNQSFOESFMFTDPNQMJDBUJPOTIBCJUVFMMFTBTTPDJÏFTËMBNJTFFOQMBDFEFTUFOUTFOEPWBTDVMBJSFTFUEhFOEPQSPUIÒTFT
DPVWFSUFTBJOTJRVhBVYSÏWJTJPOTEFTIVOUEhBCPSEEFEJBMZTF
Les complications potentielles pouvant se produire sont les suivantes (liste non exhaustive) :
BCDÒTJOGFDUJPOBVTJUFEhBCPSESÏBDUJPOBMMFSHJRVFBOBQIZMBDUPÕEFBNQVUBUJPOBOÏWSJTNFBOHJOFJTDIÏNJFDPSPOBJSFGJTUVMF
BSUÏSJPWFJOFVTFBSZUINJFTBJHOFNFOUBVTJUFEhBCPSEQPOUBHFBDDJEFOUWBTDVMBJSFDÏSÏCSBMJOTVGGJTBODFDBSEJBRVFDPOHFTUJWF
FNCPMJTBUJPO FYUSBWBTBUJPO GJÒWSF IÏNBUPNF IÏNPSSBHJF IÏNPQUZTJF IZQPUFOTJPOIZQFSUFOTJPO MÏTJPOEJTTFDUJPO EF
MJOUJNB JTDIÏNJFJOGBSDUVT EF UJTTVEhPSHBOF JOGFDUJPO JOGBSDUVT EV NZPDBSEF PDDMVTJPO EPVMFVST FNCPMJF QVMNPOBJSF
QFSGPSBUJPOTBJHOFNFOUQSPMPOHÏQTFVEPBOÏWSJTNFVSUJDBJSFSÏBDUJPOBVQSPEVJUEFDPOUSBTUFJOTVGGJTBODFSÏOBMFUPYJDJUÏ
SÏOBMFSBEJPMÏTJPOSFTUÏOPTFTFQUJDÏNJFCBDUÏSJÏNJFTFQTJT"7$UISPNCVTWBTPTQBTNFGJCSJMMBUJPOWFOUSJDVMBJSFSVQUVSFEFT
WBJTTFBVYFUEÏDÒT
Les effets indésirables spécifiques à l'abord AV peuvent inclure, sans s'y limiter :
EÒNFEVCSBTPVEFMBNBJOTZOESPNFEFEÏUPVSOFNFOUFUEÒNFEFMBGBDFPVEVDPV
Les événements spécifiques à l'endoprothèse couverte pouvant être associés aux complications cliniques sont
(liste non exhaustive) :
FNCPMJFGSBDUVSFFYQBOTJPOJOTVGGJTBOUFEF MhFOEPQSPUIÒTFDPVWFSUFQMJBHFNJTFFOQMBDF FSSPOÏFNJHSBUJPOEÏQMBDFNFOU
FUPDDMVTJPOEFMBCSBODIFMBUÏSBMF
Les événements spécifiques au système de mise en place pouvant être associés aux complications cliniques sont,
sans s'y limiter :
GVJUF EF TBOH QBS MF TZTUÒNF EF NJTF FO QMBDF EÏGBJMMBODF EFT BTTFNCMBHFT DPMMÏT QMJBHF EV TZTUÒNF EF NJTF FO QMBDF
EÏUBDIFNFOUEFQBSUJFTEÏGBVUEFEÏQMPJFNFOUGPSDFTEFEÏQMPJFNFOUJNQPSUBOUFTJNQPTTJCJMJUÏEFTVJWJKVTRVhËMhFNQMBDFNFOU
DJCMFEÏQMPJFNFOUJNQSÏDJTJODPNQBUJCJMJUÏBWFDMFTBDDFTTPJSFTBCTFODFEFWJTJCJMJUÏTPVTSBEJPTDPQJFFUEÏQMPJFNFOUQSÏNBUVSÏ
SÉLECTION DE LA TAILLE DE L'ENDOPROTHÈSE COUVERTE
6OTPJOQBSUJDVMJFSEPJUÐUSFBQQPSUÏËMBTÏMFDUJPOEhVOEJTQPTJUJGEFUBJMMFBQQSPQSJÏF&ODBTEFEJGGÏSFODFEFEJBNÒUSFFOUSF
MhFYUSÏNJUÏFOUSBOUFFUTPSUBOUFUPVKPVSTVUJMJTFSMFEJBNÒUSFEVWBJTTFBVFOUSBOUPVEVHSFGGPO"7DPNNFEJBNÒUSFEFWBJTTFBV
EFSÏGÏSFODF
Tableau 1 : Sélection du diamètre de l'endoprothèse couverte
Diamètre de l'endoprothèse
couverte
Surdimensionnement
recommandé Diamètre du vaisseau de référence
6 mm 0,5 mm – 1,5 mm 4,5 mm – 5,5 mm
7 mm 0,5 mm – 1,5 mm 5,5 mm – 6,5 mm
8 mm 1 mm – 2 mm 6 mm – 7 mm
9 mm 1 mm – 2 mm 7 mm – 8 mm
10 mm 1 mm – 2 mm 8 mm – 9 mm
 -B SÏVUJMJTBUJPO EF DF EJTQPTJUJG NÏEJDBM DPNQPSUF VO SJTRVF EF DPOUBNJOBUJPO EhVO QBUJFOU Ë MhBVUSF ÏUBOU EPOOÏ RVF
MFTEJTQPTJUJGTNÏEJDBVYTVSUPVU DFVY ÏRVJQÏT EF MVNJÒSFT MPOHVFT FU GJOFTEhBSUJDVMBUJPOT FUPV EhJOUFSTUJDFTFOUSFMFT
DPNQPTBOUTTPOU EJGGJDJMFT WPJSF JNQPTTJCMFT Ë OFUUPZFS VOF GPJT RVF EFT MJRVJEFT PV UJTTVT DPSQPSFMT ÏWFOUVFMMFNFOU
BGGFDUÏTEhVOFDPOUBNJOBUJPOQZSPHÒOFPVNJDSPCJFOOFTPOUFOUSÏTFODPOUBDUBWFDMFEJTQPTJUJGNÏEJDBMQFOEBOUVOFEVSÏF
JOEÏUFSNJOÏF-FTSÏTJEVTEFNBUÏSJBVYCJPMPHJRVFTQFVWFOUQSPNPVWPJSMBDPOUBNJOBUJPOEVEJTQPTJUJGQBSEFTQZSPHÒOFTPV
EFTNJDSPPSHBOJTNFTQPVWBOUFOUSBÔOFSEFTDPNQMJDBUJPOTJOGFDUJFVTFTPVÐUSFËMhPSJHJOFEhVOEÏDÒT
t NE PASVUJMJTFSDIF[MFTQBUJFOUTQSÏTFOUBOUEFTUSPVCMFTEFMBDPBHVMBUJPOJSSÏNÏEJBCMFT
t NE PASVUJMJTFSDIF[MFTQBUJFOUTOFQPVWBOUSFDFWPJSVOFQSÏNÏEJDBUJPOBEÏRVBUF
t NE PASVUJMJTFSDIF[MFTQBUJFOUTQSÏTFOUBOUVOFBMMFSHJFPVVOFTFOTJCJMJUÏDPOOVFBVYQSPEVJUTEFDPOUSBTUF
t NE PASVUJMJTFSDIF[MFTQBUJFOUTQSÏTFOUBOUVOFIZQFSTFOTJCJMJUÏDPOOVFBVOJDLFMUJUBOFPVBVUBOUBMF
t NE PAS VUJMJTFS MF EJTQPTJUJG DIF[ MFT QBUJFOUT QPVS MFTRVFMT MhFYQBOTJPO UPUBMF EhVO DBUIÏUFS Ë CBMMPOOFU 15" EF UBJMMF
BQQSPQSJÏFOhBQBTQVÐUSFPCUFOVFQFOEBOUMBQSÏEJMBUBUJPOBWFDVOCBMMPOOFUEhBOHJPQMBTUJF
t NE PASVUJMJTFSDIF[MFTQBUJFOUTOFQPVWBOUQBTCÏOÏGJDJFSEVUSBJUFNFOUBOUJQMBRVFUUBJSFFUPVBOUJDPBHVMBOUSFDPNNBOEÏ
t NE PASVUJMJTFSDIF[MFTQBUJFOUTQSÏTFOUBOUVOFPCTUSVDUJPOBSUÏSJFMMFGPODUJPOOFMMFNFOUQFSUJOFOUFEFMBWPJFEhBGGMVYVO
NBVWBJTEÏCJUPVVOFBCTFODFEhÏDPVMFNFOUEJTUBM
t NE PASNFUUSFFOQMBDFDIF[MFTQBUJFOUTQSÏTFOUBOUVOFMÏTJPODJCMFBDDPNQBHOÏFEhVOUISPNCVTBJHVPVTVCBJHVJNQPSUBOU
ËQSPYJNJUÏ
t -BNJTFFOQMBDFEhVOFFOEPQSPUIÒTFDPVWFSUFTVSMBCSBODIFMBUÏSBMFEhVOWBJTTFBVQFVUFNQÐDIFSMBDJSDVMBUJPOTBOHVJOFFU
FOUSBWFSPVFNQÐDIFSEFTQSPDÏEVSFTGVUVSFT
t NE PASVUJMJTFSQPVSMFUSBJUFNFOUEFTMÏTJPOTQPVWBOUFNQÐDIFSVOQPOUBHFEFTBVWFUBHF
t NE PAS TVJWSFFUEÏQMPZFSMFTZTUÒNFFOEPWBTDVMBJSF'EBOTMBCJGVSDBUJPOBPSUPJMJBRVFEFNBOJÒSFDSPJTÏFDBSDFMBQFVU
FOUSBÔOFSVOEÏGBVUEFEÏQMPJFNFOUEFMhFOEPQSPUIÒTFDPVWFSUF
t -FTFGGFUTËMPOHUFSNFEFMBEJMBUBUJPOËSÏQÏUJUJPOEFTFOEPQSPUIÒTFTDPVWFSUFTFOEPUIÏMJBMJTÏFTOFTPOUQBTDPOOVT
AVERTISSEMENTS SPÉCIFIQUES LIÉS À L'ABORD AV
t -FTVJWJFUMFEÏQMPJFNFOUEVEJTQPTJUJGBVUPVSEhVOHSFGGPO"7FOCPVDMFOhPOUQBTÏUÏUFTUÏT
t NE PASVUJMJTFSDIF[MFTQBUJFOUTEPOUMFTHSFGGPOTEhBCPSE"7POUÏUÏJNQMBOUÏTJMZBNPJOTEFKPVSTPVEBOTVOFGJTUVMFJNNBUVSF
t -BNJTFFOQMBDFEhVOFFOEPQSPUIÒTFDPVWFSUFBVEFMËEFMhPTUJVNEFMBWFJOFDÏQIBMJRVFEBOTMBWFJOFBYJMMBJSFTPVTDMBWJÒSF
QFVUFOUSBWFSPVFNQÐDIFSVOBCPSEVMUÏSJFVS
t NE PASVUJMJTFSDIF[MFTQBUJFOUTQSÏTFOUBOUVOFCBDUÏSJÏNJFPVVOFTFQUJDÏNJFFUPVEFTQSFVWFTEhJOGFDUJPOEFMBGJTUVMF
ou du greffon.
PRÉCAUTIONS
t "WBOUEhJNQMBOUFSMhFOEPQSPUIÒTFDPVWFSUFTFSFQPSUFSBVUBCMFBVEFEJNFOTJPOOFNFOU5BCMFBVFUMJSFMFNPEFEhFNQMPJ
t -FTZTUÒNFEFNJTFFOQMBDFFTUEFTUJOÏVOJRVFNFOUBVEÏQMPJFNFOUEFMhFOEPQSPUIÒTFDPVWFSUF
t -PSTEFMBNJTFFOQMBDFEVEJTQPTJUJGTFMPOVOFUFDIOJRVFDSPJTÏFNBJOUFOJSMhFYUSÏNJUÏQSPYJNBMFEFMhFOEPQSPUIÒTFDPVWFSUF
FOQPTJUJPOESPJUFQFOEBOUUPVUFMBQSPDÏEVSFEFEÏQMPJFNFOU
t -hFOEPQSPUIÒTFDPVWFSUFJNQMBOUOFQFVUQBTÐUSFSFQPTJUJPOOÏFPVSÏDVQÏSÏFBQSÒTVOEÏQMPJFNFOUUPUBMPVQBSUJFM
t "QSÒTEÏQMPJFNFOUQBSUJFMPVDPNQMFUMhFOEPQSPUIÒTFDPVWFSUFOFQFVUQBTÐUSFSÏUSBDUÏFPVSFNPOUÏFTVSMFTZTUÒNFEFNJTF
en place.
t &ODBTEFSÏTJTUBODFJOIBCJUVFMMFQFOEBOUMhJOUSPEVDUJPOEVTZTUÒNFEhFOEPQSPUIÒTFDPVWFSUFSFUJSFSMFTZTUÒNFFUFOVUJMJTFS
un autre.
t NE PASJOUSPEVJSFPVNBOJQVMFSMFTZTUÒNFEFNJTFFOQMBDFTBOTVOGJMHVJEFEFUBJMMFBQQSPQSJÏFFUTBOTHVJEBHFSBEJPTDPQJRVF
t NE PASVUJMJTFSVOTZTUÒNFEFNJTFFOQMBDFQMJÏ
t 1PVSMFTJOUFSWFOUJPOTDPOUSPMBUÏSBMFTVOFMPOHVFHBJOFEhJOUSPEVDUJPODSPJTÏFPVVODBUIÏUFSEFHVJEBHFEPJUÐUSFNJTFO
QMBDFTVSMBCJGVSDBUJPOBPSUPJMJBRVF4hBTTVSFSRVFMhFYUSÏNJUÏQSPYJNBMFEFMhFOEPQSPUIÒTFDPVWFSUFFTUQPTJUJPOOÏFEBOT
VOFTFDUJPOESPJUFEVWBJTTFBVQFOEBOUMFEÏQMPJFNFOU
t 1FOEBOUMBMJCÏSBUJPOEFMhFOEPQSPUIÒTFDPVWFSUF NE PASUFOJSMFTFHNFOUEFDBUIÏUFSEJTUBMMPOHEFDNDBSJMEPJUQPVWPJS
bouger et coulisser librement dans la gaine de stabilisation blanche.
t -F DIJSVSHJFO EPJU GBJSF QSFVWF EhVOF BUUFOUJPO QBSUJDVMJÒSF MPST EV EÏQMPJFNFOU EF MhFOEPQSPUIÒTF DPVWFSUF QPVS EJNJOVFS
MhÏWFOUVBMJUÏEhVOFNJHSBUJPOEJTUBMFEFDFUUFEFSOJÒSF
t -hFOEPQSPUIÒTFDPVWFSUFOFQFVUQBTÐUSFQPTUEJMBUÏFBVEFMËEFTPOEJBNÒUSFJOEJRVÏTVSMhÏUJRVFUUF
t -BTÏDVSJUÏFUMhFGGJDBDJUÏEVEJTQPTJUJGQMBDÏTVSVOBOÏWSJTNFPVVOQTFVEPBOÏWSJTNFOhPOUQBTÏUÏÏWBMVÏFT
t -BTÏDVSJUÏFUMhFGGJDBDJUÏEVEJTQPTJUJGQMBDÏTVSVOTUFOUFONÏUBMOVQSÏDÏEFNNFOUNJTFOQMBDFOhPOUQBTÏUÏÏWBMVÏFT

10
INSTRUCTIONS D'ÉLIMINATION
"QSÒT VUJMJTBUJPO DF QSPEVJU QSÏTFOUF VO SJTRVF CJPMPHJRVF *M EPJU ÐUSF NBOJQVMÏ FU ÏMJNJOÏ DPOGPSNÏNFOU BVY QSBUJRVFT
NÏEJDBMFTWBMJEÏFTBJOTJRVBVYMPJTFUSÏHMFNFOUBUJPOTFUMÏHJTMBUJPOTMPDBMFTOBUJPOBMFTFUGÏEÏSBMFTFOWJHVFVS
INFORMATIONS RELATIVES À L'USAGE CLINIQUE
t -JSFBUUFOUJWFNFOUMhFOTFNCMFEVNPEFEhFNQMPJ
t 6OUSBJUFNFOUBOUJCJPUJRVFQFVUÐUSFQSFTDSJUËMBEJTDSÏUJPOEVNÏEFDJO
t 4FMPOMBMJUUÏSBUVSFDMJOJRVFQVCMJÏFTVSEFTFOEPQSPUIÒTFTDPVWFSUFTBVUPFYUFOTJCMFTTJNJMBJSFTMhJOIJCJUJPOQSPQIZMBDUJRVF
EFMhBHSÏHBUJPOQMBRVFUUBJSFEPJUÐUSFQSJTFFODPNQUFMPSTRVFMFEJTQPTJUJGFTUQMBDÏEBOTEFTBSUÒSFTJMJBRVFTPVGÏNPSBMFT
t -hFOEPQSPUIÒTFWBTDVMBJSFDPVWFSUFCOVERA™ PLUS OFEPJUÐUSFVUJMJTÏFRVFQBSEFTNÏEFDJOTRVJDPOOBJTTFOUMFTDPNQMJDBUJPOT
MFTFGGFUTTFDPOEBJSFTFUMFTSJTRVFTDPVSBNNFOUBTTPDJÏT BVY SÏWJTJPOT EF TIVOU EhBCPSEEFEJBMZTFFUBVYJOUFSWFOUJPOT
endovasculaires.
MATÉRIAUX REQUIS POUR LA PROCÉDURE D'ENDOPROTHÈSE VASCULAIRE COUVERTE COVERA™ PLUS
t 4ÏSVNQIZTJPMPHJRVFIÏQBSJOÏ
t 4FSJOHVFTTUÏSJMFTËSBDDPSE-VFS-PDL
t 1SPEVJUEFDPOUSBTUF
t 'JMHVJEFEFJODINNEhVOFMPOHVFVSBEBQUÏFQPVSQFSNFUUSFMBNJTFFOQMBDFFOUPVUFTÏDVSJUÏEFMhFOEPQSPUIÒTF
DPVWFSUFFUMFSFUSBJUEVTZTUÒNFEFNJTFFOQMBDF
t (BJOFEhJOUSPEVDUJPOEhVOEJBNÒUSFJOUÏSJFVSFUEhVOFMPOHVFVSBEBQUÏT
t $BUIÏUFSTEFEJBHOPTUJDFUBDDFTTPJSFT
t $BUIÏUFSEhBOHJPQMBTUJFËCBMMPOOFUQPVSMBQSÏEJMBUBUJPOPVMBQPTUEJMBUBUJPO
t %JTQPTJUJGEFHPOGMBHF
MODE D'EMPLOI
Préparation
 "QSÒTMFSFUSBJUEFMhFNCBMMBHFWÏSJGJFSRVFMFWFSSPVJMMBHFEFTÏDVSJUÏFTUFOQPTJUJPOCMPRVÏF
REMARQUE :
 "QSÒTMhBWPJSMVFEÏDIJSFSMhÏUJRVFUUFQBQJFSDPOUFOBOUMFTDPOTJHOFTEFTÏDVSJUÏEFMBQPJHOÏFEVTZTUÒNFFOEPWBTDVMBJSF'
 ®MhBJEFEFUFDIOJRVFTTUBOEBSEEhBCPSEFOEPWBTDVMBJSFFUEFSBEJPTDPQJFBDDÏEFSBVWBJTTFBVDJCMFEFQVJTVOTJUFQFSNFUUBOU
MFDIFNJOFNFOUMF QMVT ESPJUQPTTJCMFKVTRVhËMBMÏTJPO DJCMF FUGBJSFBWBODFS VOGJMHVJEF EFJODINNTVSMB
MÏTJPODJCMF
 1PVSMFTQSPDÏEVSFTDPOUSPMBUÏSBMFTVOFMPOHVFHBJOFEhJOUSPEVDUJPODSPJTÏFPVVODBUIÏUFSEFHVJEBHFEPJUÐUSFQMBDÏTVSMB
bifurcation aorto-iliaque.
 1SÏEJMBUFSMBTUÏOPTFBWFDVODBUIÏUFSËCBMMPOOFU15"EFMPOHVFVSFUEFEJBNÒUSFBEBQUÏTËMBMÏTJPOËUSBJUFS
 4ÏMFDUJPOOFSMFEJBNÒUSFEhFOEPQSPUIÒTFDPVWFSUFBQQSPQSJÏTFMPOMFUBCMFBVEFEJNFOTJPOOFNFOU5BCMFBV
 &YBNJOFSMhFNCBMMBHFFUMFTZTUÒNFEFNJTFFOQMBDFQPVSSFQÏSFSEhÏWFOUVFMTEÏHÉUTFUWÏSJGJFSRVFMBCBSSJÒSFTUÏSJMFOhBQBT
ÏUÏDPNQSPNJTF-FDBTÏDIÏBOUOFQBTVUJMJTFSMFEJTQPTJUJG
 3JODFSMFTZTUÒNFEFNJTFFOQMBDFËUSBWFSTMFSBDDPSE-VFSËMhFYUSÏNJUÏQSPYJNBMFEFMBQPJHOÏFBWFDEVTÏSVNQIZTJPMPHJRVF
TUÏSJMFKVTRVhËDFRVFMBTPMVUJPOThÏDPVMFËMhFYUSÏNJUÏEVTZTUÒNF'JHVSF
Figure 4
REMARQUE : Ne pas rétracter le verrouillage de sécurité avant que l'endoprothèse couverte ne soit positionnée sur
la lésion et prête à être déployée.
Introduction du système de mise en place
 4PVTHVJEBHFSBEJPTDPQJRVFGBJSFBWBODFSMFTZTUÒNFEFNJTFFOQMBDFQBSEFTTVTMFGJMHVJEFBVEFMËEFMBMÏTJPODJCMFQVJT
UJSFSMÏHÒSFNFOU TVS MFTZTUÒNFFOUJFSQPVSPCUFOJSVO QPTJUJPOOFNFOUDPSSFDUEFTNBSRVFVSTSBEJPPQBRVFT6UJMJTFS MFT
FYUSÏNJUÏTSBEJPPQBRVFTEFMhFOEPQSPUIÒTFDPVWFSUFQPVSDFOUSFSDFUUFEFSOJÒSFTVSMBMÏTJPO'JHVSF
Longueur de l'endoprothèse couverte
7FJMMFSËDFRVFMhFOEPQSPUIÒTFDPVWFSUFTÏMFDUJPOOÏFDPVWSFUPVUFMBMÏTJPOFUËDFRVFMFTEFVYFYUSÏNJUÏTEFMhJNQMBOUEÏQBTTFOU
EhBVNPJOTNNËMhJOUÏSJFVSEVTFHNFOUTBJOEVWBJTTFBV&ODBTEFDIFWBVDIFNFOUEFTEJTQPTJUJGTVODIFWBVDIFNFOUEhBV
NPJOTNNFTUSFDPNNBOEÏFOUSFMFTEJTQPTJUJGT
1PVSMBNJTFFOQMBDFEhFOEPQSPUIÒTFTDPVWFSUFTEBOTMhBSDIFDÏQIBMJRVFQSPYJNBMFTÏMFDUJPOOFSMBMPOHVFVSWPVMVFQPVSDPVWSJS
FOUJÒSFNFOUMBMÏTJPOPTUJBMFFUEFGBÎPOËDFRVFMhFOEPQSPUIÒTFDPVWFSUFNBYJNBMFOFDPNQSPNFUUFQBTMFGMVYEBOTMBWFJOF
BYJMMBJSFTPVTDMBWJÒSF7FJMMFSËDFRVFMhFYUSÏNJUÏEFMhFOEPQSPUIÒTFDPVWFSUFEÏQBTTFEhBVNPJOTNNBVEFMËEFMBDPVSCVSF
EFMhBSDIFEBOTMFTFHNFOUEJTUBMESPJUEFMBWFJOFDÏQIBMJRVF
REMARQUE : Le raccourcissement de l'endoprothèse vasculaire couverte COVERA™ PLUS est de ≤ 13%.
COMPATIBILITÉ AVEC L'IMAGERIE PAR RÉSONANCE MAGNÉTIQUE IRM
%FTFTTBJTOPODMJOJRVFTPOUNPOUSÏRVFMhFOEPQSPUIÒTFWBTDVMBJSFDPVWFSUFCOVERA™ PLUSFTUDPNQBUJCMFBWFDMh*3.TPVTDFSUBJOFT
DPOEJUJPOTQPVSMBNJTFFOQMBDFEhVOFFOEPQSPUIÒTFDPVWFSUF VOJRVF EBOT MFT WBJTTFBVY EV CSBTFUMBNJTFFOQMBDFEhVOF
FOEPQSPUIÒTFDPVWFSUFVOJRVFPVEhFOEPQSPUIÒTFTDPVWFSUFTTFDIFWBVDIBOUEBOTMFTBSUÒSFTJMJBRVFTFUGÏNPSBMFTTVQFSGJDJFMMFT
QPVSUPVUFTMFTMPOHVFVSTDMJOJRVFNFOUQFSUJOFOUFT4VSMBCBTFEFTUFTUTQSÏDMJOJRVFTMFTQBUJFOUTQPSUFVSTEFMhFOEPQSPUIÒTF
vasculaire couverte COVERA™ PLUSQFVWFOUTVCJSVOFYBNFOEhJNBHFSJFTBOTEBOHFSJNNÏEJBUFNFOUBQSÒTMBNJTFFOQMBDFEFDFU
implant dans les conditions suivantes :
t $IBNQNBHOÏUJRVFTUBUJRVFEF5FTMBPV5FTMB
t $IBNQËHSBEJFOUTQBUJBMJOGÏSJFVSPVÏHBMË(BVTTDN
t %ÏCJUEhBCTPSQUJPOTQÏDJGJRVF%"4NPZFOQPVSMFDPSQTFOUJFSNBYJNVNEF8LHQFOEBOUNJOVUFTEhFYQPTJUJPO
t 'PODUJPOOFNFOUFONPEFOPSNBMEVTZTUÒNF*3.
Augmentation de température avec une machine de 3,0 Tesla
6OFBOBMZTFCBTÏFTVSEFTFTTBJTOPODMJOJRVFTTFMPOMBOPSNF"45.'BFUTVSMBNPEÏMJTBUJPOJOGPSNBUJRVFEhVOQBUJFOU
B EÏUFSNJOÏ RVF MhFOEPQSPUIÒTF WBTDVMBJSF DPVWFSUF COVERA™ PLUS de 6 x 100 mm unique produit, dans le pire des cas, une
BVHNFOUBUJPOQPUFOUJFMMFEFMBUFNQÏSBUVSFJOGÏSJFVSFË¡$QPVSVO%"4QPVSMFDPSQTFOUJFSEF8LHQFOEBOUNJOVUFT
EhFYQPTJUJPO*3. EBOT VO TZTUÒNF*3.DPSQTFOUJFSEF5FTMB-FSFGSPJEJTTFNFOUMJÏËMBDJSDVMBUJPO TBOHVJOF Ë MhJOUÏSJFVS
EF MhFOEPQSPUIÒTF DPVWFSUF FU MB QFSGVTJPO EBOT MF SÏTFBV WBTDVMBJSF FOUPVSBOU MhFOEPQSPUIÒTF DPVWFSUF POU ÏUÏ JODMVT EBOT
MhÏWBMVBUJPOEFMhBVHNFOUBUJPOEFMBUFNQÏSBUVSFJOWJWP
Augmentation de température avec une machine de 1,5 Tesla
6OFBOBMZTFCBTÏFTVSEFTFTTBJTOPODMJOJRVFTTFMPOMBOPSNF"45.'BFUTVSMBNPEÏMJTBUJPOJOGPSNBUJRVFEhVOQBUJFOU
B EÏUFSNJOÏ RVF MhFOEPQSPUIÒTF WBTDVMBJSF DPVWFSUF COVERA™ PLUS de 6x 100 mm unique produit, dans le pire des cas, une
BVHNFOUBUJPOQPUFOUJFMMFEFMBUFNQÏSBUVSFJOGÏSJFVSFË¡$QPVSVO%"4QPVSMFDPSQTFOUJFSEF8LHQFOEBOUNJOVUFT
EhFYQPTJUJPO*3. EBOT VO TZTUÒNF*3.DPSQTFOUJFSEF5FTMB-FSFGSPJEJTTFNFOUMJÏËMBDJSDVMBUJPO TBOHVJOF Ë MhJOUÏSJFVS
EF MhFOEPQSPUIÒTF DPVWFSUF FU MB QFSGVTJPO EBOT MF SÏTFBV WBTDVMBJSF FOUPVSBOU MhFOEPQSPUIÒTF DPVWFSUF POU ÏUÏ JODMVT EBOT
MhÏWBMVBUJPOEFMhBVHNFOUBUJPOEFMBUFNQÏSBUVSFJOWJWP
Artefact d'image
%FTFTTBJTEhBSUFGBDU POUÏUÏSÏBMJTÏTTFMPO MBOPSNF"45.'-BRVBMJUÏ EFTJNBHFT*3.QFVUÐUSFDPNQSPNJTFTJMB
[POFEhJOUÏSÐUTF USPVWF FYBDUFNFOU EBOT MBNÐNF[POFPVSFMBUJWFNFOU QSPDIF EFMBQPTJUJPOEF MhFOEPQSPUIÒTFDPVWFSUF
-hBSUFGBDUNBYJNVNEÏQBTTBJUEFNNBVEFMËEFMhFOEPQSPUIÒTFDPVWFSUFQPVSMBTÏRVFODFEhÏDIPEFTQJOFUEFNNQPVS
MBTÏRVFODFEhÏDIPEFHSBEJFOU-BMVNJÒSFBÏUÏPDDVMUÏF
Informations supplémentaires
-FTCPOOFTQSBUJRVFTDMJOJRVFTFONBUJÒSFEh*3.EPJWFOUÐUSF TVJWJFTOPUBNNFOUMB NJTF FO QMBDF EhVO SFNCPVSSBHF FOUSF
MBQBSPJEVDBOBMFUMFQBUJFOUBJOTJRVFMhÏWJUFNFOUEFUPVUDPOUBDUFOUSFMFTNBJOTFUMFDPSQT
-hFOEPQSPUIÒTF WBTDVMBJSF DPVWFSUF COVERA™ PLUS OhB GBJU MhPCKFU EhBVDVOF ÏWBMVBUJPO EBOT EFT TZTUÒNFT *3. QSÏTFOUBOU EFT
JOUFOTJUÏTEFDIBNQBVUSFTRVFPV5FTMB-hFGGFUEFMBDIBMFVSEBOTMhFOWJSPOOFNFOU*3.TVSEFTFOEPQSPUIÒTFTDPVWFSUFT
GSBDUVSÏFTFTUJODPOOV-BQSÏTFODFEhBVUSFTJNQMBOUTPVMhÏUBUEFTBOUÏEVQBUJFOUQFVUOÏDFTTJUFSVOFSÏEVDUJPOEFTMJNJUFTEh*3.
ÏOPODÏFTQMVTIBVU
CONDITIONNEMENT
-hFOEPQSPUIÒTFWBTDVMBJSFDPVWFSUFCOVERA™ PLUS FTUGPVSOJFTUÏSJMFËMhPYZEFEhÏUIZMÒOF&MMFFTUËVTBHFVOJRVF
CONSERVATION
$POTFSWFSEBOTVOFOESPJUGSBJTFUTFD$POTFSWFSËMBCSJEVTPMFJMNE PAS utiliser le dispositif BQSÒTMBEBUFEhFYQJSBUJPOJOEJRVÏF
TVSMhÏUJRVFUUF