GORE VIABAHN Gebrauchsanweisung Seite 5

the endoprosthesis overlap the native vessel at least 1 cm beyond the proximal and distal margins of the lesion when treating
stenotic or occlusive lesions and preferably at least 2 cm beyond the proximal and distal margins of the lesion when treating
aneurysmal lesions. When treating an arteriovenous graft outflow lesion that starts 30 mm or less from the venous anastomosis,
the endoprosthesis should overlap the prosthetic graft by at least 1 cm.
c. Verify that there is sufficient catheter length to access the treatment site.
2. When overlapping (telescoping) multiple devices, the following are suggested:
a. Balloon touch-up (post-dilatation) should be performed on the first device prior to placing the second device.
b. To ensure proper seating, at least 1 cm of overlap between devices is suggested.
c. If unequal device diameters are used, the smaller device should be placed first and then the larger device should be placed inside
of the smaller device.
d. Overlapping devices should not differ by more than 1 mm in diameter (with the exception that the 13 mm diameter device may
be overlapped into the 11 mm diameter device).
e. When overlapping inside aneurysmal lesions, at least 2 cm of overlap between devices is suggested.
E. Preparation of the GORE® VIABAHN® Endoprosthesis
1. Opening the Sterile Package.
Carefully inspect the packaging for damage to the sterile barrier. Do not use the GORE® VIABAHN® Endoprosthesis after the "use
by" (expiration) date. Peel back the outer pouch and remove the sterile inner pouch and coil containing the GORE® VIABAHN®
Endoprosthesis. Beginning at one corner, peel back the edge of the inner pouch and gently remove the GORE® VIABAHN®
Endoprosthesis.
2. Inspection Prior to Use.
a. Prior to using the GORE® VIABAHN® Endoprosthesis, all materials and equipment to be used for the procedure should be carefully
examined for bends, kinks, or other damage.
b. Do not use any defective equipment.
c. Do not use the GORE® VIABAHN® Endoprosthesis if the sterile package is compromised or the GORE® VIABAHN® Endoprosthesis is
damaged.
3. Preparation of the GORE® VIABAHN® Endoprosthesis delivery catheter.
a. Flush the delivery catheter by attaching a syringe of sterile saline to the flushing port on the catheter adapter (Figure 2). Continue
flushing until a steady stream of fluid exits the tip of the catheter and the deployment lumen at the proximal end of the device.
After flushing the catheter, remove the syringe.
F. Introduction and Positioning of the GORE® VIABAHN® Endoprosthesis
1. Select the compatible size introducer sheath from Table 1.
2. Ensure the 0.035" (0.889 mm) diameter stiff guidewire has a length at least twice that of the delivery catheter.
3. Be sure to remove the balloon catheter while maintaining the position of the guidewire beyond the target lesion.
4. With the delivery catheter as straight as possible, insert the guidewire into the tip of the delivery catheter while supporting the
delivery catheter and the compressed endoprosthesis. Carefully advance the endoprosthesis in small increments (approximately
0.5 cm) over the guidewire, through the hemostasis valve and introducer sheath, and into the access vessel.
Note: If excessive resistance is felt as the GORE® VIABAHN® Endoprosthesis is introduced through the hemostasis valve, remove
and inspect the delivery system for damage. Do not reuse the GORE® VIABAHN® Endoprosthesis if damaged. Ensure a compatible
introducer sheath size (Table 1), and that the introducer sheath is free of kinks.
5. Using fluoroscopic guidance, advance the delivery catheter over the guidewire via the angiographic sheath. Advance cautiously,
especially if resistance is felt. If excessive resistance is felt, remove the delivery catheter and angiographic sheath together as
described in step F. 7.
6. Position the GORE® VIABAHN® Endoprosthesis across the target lesion using the radiopaque markers. For 5-8 mm devices:
markers are located on the graft material within the last row of the stent (see Figure 1A) and can be used to identify the proximal
and distal ends of the compressed endoprosthesis. Radiopaque markers are also present on the catheter shaft proximal to the
endoprosthesis and on the tip of the catheter. For 9-13 mm devices: radiopaque markers are present on the catheter shaft proximal
to the endoprosthesis and on the tip of the catheter. These markers identify the proximal and distal ends of the endoprosthesis,
respectively.
Note: If PTA is performed, the endoprosthesis length should cover the entire vessel segment treated with balloon angioplasty. For
treatment of stenotic or occlusive lesions, the endoprosthesis should extend at least 1 cm proximal and distal to the margins of the
lesion, and at least 2 cm beyond the proximal and distal margins of the lesion when treating aneurysmal lesions. For a lesion that
starts within 30 mm of the venous anastomosis of an arteriovenous graft, the endoprosthesis should overlap the prosthetic graft by
at least 1 cm.
7. Once the optimal position is verified fluoroscopically, the endoprosthesis is ready to be deployed.
Note: Should it become necessary to remove the GORE® VIABAHN® Endoprosthesis from the vessel prior to deployment, do not
withdraw the GORE® VIABAHN® Endoprosthesis back into the introducer sheath after the endoprosthesis is fully introduced. To
remove the GORE® VIABAHN® Endoprosthesis prior to deployment, the GORE® VIABAHN® Endoprosthesis can be withdrawn 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, neither the GORE® VIABAHN® Endoprosthesis nor the introducer sheath should be reused.
G. Deployment of the GORE® VIABAHN® Endoprosthesis
1. Stabilize the delivery catheter at the hemostasis valve of the introducer sheath. It is also important to stabilize the delivery catheter
and introducer sheath relative to the patient. This will minimize catheter movement during deployment and ensure accurate
endoprosthesis positioning.
2. Untwist the screw-connector at the base of the deployment knob. While keeping the extracorporeal segment of the catheter as
straight as possible, slowly pull the deployment knob away from the adapter. Deployment of the endoprosthesis will occur from
the tip of the delivery catheter toward the hub. If deployed as instructed, the endoprosthesis should not appreciably shorten.
Note: Once deployment has started, repositioning of the endoprosthesis should not be attempted.
3. While maintaining the position of the guidewire across the treated lesion, carefully withdraw the delivery catheter through the
lumen of the endoprosthesis and remove it via the introducer sheath. Moderate resistance may be felt when the distal tip exit
through the hemostasis valve of the introducer sheath.
Note: If, during catheter removal, the tip olive catches on the leading edge of the endoprosthesis, a slight "back and forth" motion
of the catheter may aid in release. Excessive or abrupt force during catheter removal may damage the endoprosthesis or cause
separation at the catheter tip.
4. After deployment, the endoprosthesis must be smoothed and seated against the vessel wall by inflating an angioplasty balloon
within it. Touch-up balloon diameter should be selected according to Table 1. It should be inflated to the desired diameter along the
entire length of the endoprosthesis. If the endoprosthesis length exceeds that of the balloon, multiple inflations may be needed.
After the balloon is inflated throughout the endoprosthesis, attention is required to ensure complete deflation of the balloon prior to
cautious removal of the balloon catheter to prevent endoprosthesis displacement. Do not extend balloon dilatation beyond the ends
of the device and into healthy vessel.
5. Using contrast angiography, evaluate the treated segment prior to completing the procedure. Further balloon inflations may be
necessary if residual endoprosthesis folds or invaginations are visualized angiographically. A final angiographic run to evaluate vessel
patency to the foot is recommended.
6. When clinically appropriate, remove the introducer sheath and achieve hemostasis of the puncture site.
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