Directions For Use - GORE VIABAHN Gebrauchsanweisung

• The GORE® VIABAHN® Endoprosthesis should only be used by physicians trained in its use.
• Follow the Directions for Use supplied with all accessories used in conjunction with the GORE® VIABAHN® Endoprosthesis.
• Once deployment is started, repositioning the endoprosthesis should not be attempted.
• Do not dilate the endoprosthesis with a balloon longer than the labeled endoprosthesis length (Table 1). Refer to Sizing Table (Table 1)
for selection of appropriate balloon diameter.
• Do not attempt to withdraw or reposition a balloon catheter within the lumen of the deployed endoprosthesis unless the balloon is
completely deflated.
• Antiplatelet medication should be initiated prior to placement of the GORE® VIABAHN® Endoprosthesis. Effective anticoagulation
therapy should be maintained at a dosage deemed appropriate by the physician.
• No clinical events related to heating effects of GORE® VIABAHN® Endoprostheses in the MRI environment have been reported. The effect
of heating in the MRI environment for devices with fractured stent struts is not known.
MRI Safety and Compatibility
Non-clinical testing has demonstrated that the GORE® VIABAHN® Endoprosthesis is MR Conditional for lengths up to 490mm.
It can be scanned safely under the following conditions:
• Static magnetic field of 1.5 or 3.0 Tesla
• Highest spatial gradient magnetic field of 3000 Gauss/cm or less
• Maximum whole-body-averaged specific absorption rate (SAR) of 4.0W/kg in the First Level Controlled Mode for 15 minutes of
scanning
3.0 Tesla Temperature Rise:
In non-clinical testing, the GORE® VIABAHN® Endoprosthesis is expected to produce a temperature rise of 3.3°C at an MR system reported
maximum whole bodied averaged specific absorption rate (SAR) of 4.0W/kg for 15 minutes of MR scanning in a 3.0 Tesla, Excite, General
Electric active-shield, horizontal field MR scanner using G3.0-052B Software and placed in a worst-case location in a phantom designed
to simulate human tissue.
1.5 Tesla Temperature Rise:
In non-clinical testing, the GORE® VIABAHN® Endoprosthesis is expected to produce a temperature rise of 3.4°C at an MR system reported
maximum whole bodied averaged specific absorption rate (SAR) of 4.0W/kg for 15 minutes of MR scanning in a 1.5 Tesla, Magnetom,
Siemens Medical Solutions, active-shield, horizontal field MR scanner using Numaris/4 Software and placed in a worst-case location in a
phantom designed to simulate human tissue.
Image Artifact:
The image artifact extends approximately 2 – 5 mm from the device, both inside and outside the device lumen when scanned in non-
clinical testing using sequence: T1 – weighted, spin echo and gradient echo pulse sequences in a 3.0 Tesla, Excite, General Electric active-
shield, horizontal field MR system with a send-receive RF body coil.
For each vascular device and assembly, the artifacts that appeared on the MR images were shown as localized signal voids (i.e., signal
loss) that were minor in size relative to the size and shape of these implants. The gradient echo pulse sequence produced larger artifacts
than the T1 – weighted, spin echo pulse sequence for the GORE® VIABAHN® Endoprosthesis. 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 GORE® VIABAHN® Endoprosthesis. Therefore, it may
be necessary to optimize the MR imaging parameters to compensate for the presence of this implant.
HAZARDS AND ADVERSE EVENTS
Procedure Related: As with all procedures that utilize techniques for introducing a catheter into a vessel, complications may be
expected. These complications include, but are not limited to: access site infection; entry site bleeding and / or hematoma; vessel
thrombosis, occlusion, pseudoaneurysm, and trauma to the vessel wall (including rupture or dissection); distal embolization;
arteriovenous fistula formation; transient or permanent contrast induced renal failure; renal toxicity; sepsis; shock; radiation injury;
myocardial infarction; fever; pain; malposition; malapposition; inflammation; and / or death.
Device Related: Complications and adverse events can occur when using any endovascular device. These complications include, but are
not limited to: hematoma; stenosis, thrombosis or occlusion; distal embolism; side branch occlusion; vessel wall trauma and / or rupture;
false aneurysm; infection; inflammation; fever and / or pain in the absence of infection; deployment failure; migration; and device failure.
MATERIALS REQUIRED FOR IMPLANTATION
• GORE® VIABAHN® Endoprosthesis
• Marker guidewire or catheter (for calibrated measurement reference)
• Syringe filled with heparinized saline
• Introducer sheath of appropriate size (Table 1)
• 0.035" (0.889 mm) diameter stiff guidewire
• Guidewire length should be at least twice the length of the GORE® VIABAHN® Endoprosthesis delivery catheter
• Appropriate angioplasty balloon catheters and accessories (Table 1)
• Appropriate diagnostic catheters and accessories
Treatment of Vessel Obstruction
A. Access
1. Using appropriate local anesthesia, access is achieved using the appropriate vessel. When possible, a percutaneous Seldinger
technique is preferred. A cutdown may be performed when indicated.
2. Using standard technique, insert the appropriately sized angiographic vascular introducer sheath into the vessel.
B. Imaging and Measurement
1. To achieve accurate measurement and ensure precise sizing and placement of the endoprosthesis, use image-centered, magnified-
view contrast angiography, including a marker guidewire or catheter.
C. Percutaneous Transluminal Angioplasty (PTA) (if treating stenotic or occlusive lesions)
1. Refer to manufacturer's Directions for Use.
2. Inflate the angioplasty balloon to its nominal pressure according to manufacturer's Directions for Use. Ensure full expansion of the
balloon within the lesion.
Note: Carefully mark the margins of the angioplasty treatment segment in order to ensure complete coverage with the
endoprosthesis.
3. Following deflation of the angioplasty balloon, evaluate the results angiographically. For reference, measure the native vessel
diameter, lesion length, and residual percent stenosis.
D. Sizing and Selection of the GORE® VIABAHN® Endoprosthesis
1. Prior to opening the sterile package, check that the diameter and length of the endoprosthesis as well as the delivery catheter
length are correct before removing from the packaging.
a. In selecting the appropriate size endoprosthesis, a careful assessment of the vessel is necessary. In general, to assure adequate
anchoring, the diameter of the endoprosthesis should be approximately 5 – 20% larger than the healthy vessel diameter
immediately proximal and distal to the lesion (Table 1).
b. The endoprosthesis lengths of the GORE® VIABAHN® Endoprosthesis listed in Table 1 are nominal. It is, therefore, important that
MR Conditional

DIRECTIONS FOR USE

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