GORE VIABAHN Gebrauchsanweisung Seite 3

TABLE 1: SIZING TABLE
Device Sizing
Labeled Device Recommended Vessel
Diameter (mm) Diameter1 (mm)
5 4.0 – 4.7
6 4.8 – 5.5
7 5.6 – 6.5
8 6.6 – 7.5
9 7.6 – 8.5
10 8.6 – 9.5
11 9.6 – 10.5
13 10.6 – 12.0
1 Recommended endoprosthesis compression within the vessel is approximately 5 – 20%.
2 Labeled device lengths are nominal.
3 For the 11 and 13 mm diameter devices, balloon inflation pressure should not exceed 8 atm.
4 The 10 mm diameter device is compatible with the following 10 Fr introducer sheaths: Cordis AVANTI® Sheath Introducer, Boston
Scientific SUPER SHEATH Introducer Sheath, B. Braun INTRADYN Tear-Away Introducer Sheath.
PACKAGE HANDLING
• Store in a cool dry place. This product has an expiration date and should be used before the labeled "use by" (expiration) date marked
on the box.
METHOD
• Preparation of patients receiving the GORE® VIABAHN® Endoprosthesis should include initiation of an appropriate dosage of oral
antiplatelet medication prior to and following the procedure. Effective anticoagulation therapy should be maintained throughout the
procedure and continued into the postoperative period, as deemed appropriate by the treating physician.
• Prior to implantation of the GORE® VIABAHN® Endoprosthesis, the physician should refer to the Sizing Table (Table 1) and
read the Directions for Use.
• When used in the treatment of stenotic or occlusive lesions, placement of the GORE® VIABAHN® Endoprosthesis should immediately
follow successful transluminal balloon angioplasty confirmed by angiography. The endoprosthesis must be sized in accordance with the
Sizing Table (Table 1) using accurate measurement techniques.
• Proper placement of the endoprosthesis should be monitored and confirmed using fluoroscopy.
• Sterile precautions should be the same as for any device implant procedure.
• To ensure an optimal result, the endoprosthesis must be dilated after deployment with an appropriately sized balloon (Table 1). Do not
extend balloon dilatation beyond the ends of the device and into healthy vessel.
WARNINGS
• W. L. Gore & Associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness
of the GORE® VIABAHN® Endoprosthesis in applications other than the endovascular grafting of peripheral arteries and improving blood
flow in symptomatic obstructions of peripheral veins.
• W. L. Gore & Associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness
of the GORE® VIABAHN® Endoprosthesis in applications where the device is deployed within stents or stent grafts other than the GORE®
VIABAHN® Endoprosthesis. Other devices may interfere with the deployment of the GORE® VIABAHN® Endoprosthesis resulting in
deployment failure or other device malfunction.
• The GORE® VIABAHN® Endoprosthesis is not indicated for use in the central circulatory system; such as, pulmonary arteries, aorta,
coronary arteries, coronary bypass grafts, coronary sinus, carotid arteries, vertebral arteries, brachiocephalic (innominate) arteries, vena
cavae or pulmonary veins.
• W. L. Gore & Associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness
of the GORE® VIABAHN® Endoprosthesis in applications where the endoprosthesis may experience repeated and extreme flexion, such
as across the popliteal fossa and the anticubital fossa. Clinical conditions such as excessive bending, tortuosity, and / or repeated and
extreme flexion may result in compromised performance or failure of the endoprosthesis.
• Do not use the GORE® VIABAHN® Endoprosthesis for the treatment of lesions that would not allow an operative salvage bypass
procedure.
• Do not use the GORE® VIABAHN® Endoprosthesis for the treatment of ostial lesions or lesions involving a major side branch that may be
covered by the endoprosthesis.
• Do not use in patients with less than one distal run-off vessel which has continuous patency to the ankle.
• Do not use in patients with a history of intolerance or adverse reaction to antiplatelet and / or anticoagulation therapies, bleeding
diathesis, severe hypertension or renal failure.
• Special care should be taken to ensure that the appropriate size endoprosthesis, compatible sheath and guidewire are selected prior to
introduction. Native vessel dimensions must be accurately measured, not estimated.
• Do not cannulate or puncture the GORE® VIABAHN® Endoprosthesis. Cannulating or puncturing the endoprosthesis may result
in damage to the ePTFE lining and / or the external nitinol support, resulting in compromised performance or failure of the
endoprosthesis.
• Do not cut the endoprosthesis. The endoprosthesis should only be placed and deployed using the supplied catheter system.
• Do not use a kinked introducer sheath. A kinked introducer sheath may increase the force necessary to deploy the endoprosthesis and
may cause a deployment failure or catheter breakage on removal.
• Do not attempt to deploy the endoprosthesis or manipulate the delivery system without an appropriately sized guidewire (Table 1) or
fluoroscopic guidance.
• Do not withdraw the GORE® VIABAHN® Endoprosthesis back into the introducer sheath once the endoprosthesis is fully introduced.
Withdrawing the GORE® VIABAHN® Endoprosthesis back into the sheath can cause damage to the endoprosthesis, premature
deployment, deployment failure, and / or catheter separation. If removal prior to deployment is necessary, withdraw the GORE®
VIABAHN® Endoprosthesis to a position close to but not into the introducer sheath. Both the GORE® VIABAHN® Endoprosthesis and
introducer sheath can then be removed in tandem. After removal, do not reuse the GORE® VIABAHN® Endoprosthesis or introducer
sheath.
• Inadvertent, partial, or failed deployment or migration of the endoprosthesis may require surgical intervention.
PRECAUTIONS
• The GORE® Medical Device is designed for single use only; do not reuse device. Gore does not have data regarding reuse of this device.
Reuse may cause device failure or procedural complications including device damage, compromised device biocompatibility, and device
contamination. Reuse may result in infection, serious injury, or patient death.
• W. L. Gore & Associates has insufficient technical information to recommend reuse or reprocessing of the GORE® VIABAHN®
Endoprosthesis. However, reasonably foreseeable clinical complications that may result from inappropriate reuse or reprocessing
include, but are not limited to: deployment failure, catheter failure, infection, irritation, vessel damage or loss of biocompatibility.
• Do not use the GORE® VIABAHN® Endoprosthesis if the sterile package is compromised or the GORE® VIABAHN® Endoprosthesis is
damaged.
• Do not use the GORE® VIABAHN® Endoprosthesis after the labeled "use by" (expiration) date.
• Do not resterilize the GORE® VIABAHN® Endoprosthesis.
Endoprosthesis Introducer Sheath
Radiopaque Markers Size (Fr)
Yes 7
Yes 7
Yes 8
Yes 8
No 9
No 114
No 11
No 12
Available Device Guidewire
Lengths2 (cm) Diameter
2.5, 5, 10, 15 0.035" (0.889 mm)
2.5, 5, 10, 15 0.035" (0.889 mm)
2.5, 5, 10, 15 0.035" (0.889 mm)
2.5, 5, 10, 15 0.035" (0.889 mm)
5, 10, 15 0.035" (0.889 mm)
5, 10, 15 0.035" (0.889 mm)
5, 10 0.035" (0.889 mm)
5, 10 0.035" (0.889 mm)
2
Recommended Balloon
Deployment
Diameter for Device
Direction
Touch-up (mm)3
5.0 Tip to hub
6.0 Tip to hub
7.0 Tip to hub
8.0 Tip to hub
9.0 Tip to hub
10.0 Tip to hub
12.0 Tip to hub
14.0 Tip to hub