With its advanced materials and design, and precision deployment system, the GORE® TIGRIS® Vascular Stent provides fracture resistance that we stand behind with a refund for demonstrable frame fractures.* Stent frame fractures are a known risk for any vascular stent and can be caused by a wide range of factors including patient anatomy, pathology, and other clinical aspects. We are so confident our stent design can stand up to these challenges that we want to pass certainty to you with our fracture-free assurance program.
* Subject to the terms and conditions.
TERMS AND CONDITIONS
Gore will provide the hospital with a refund of the price of the GORE® TIGRIS® Vascular Stent (“device”) for the patient if there is a demonstrated frame fracture within ten (10) years of implantation. The refund is only available if the GORE® TIGRIS® Vascular Stent meets the following terms and conditions:
- Selected by a physician who confirms the device is medically necessary and clinically appropriate for the particular patient
- Used in accordance with the device Instructions for Use (IFU)
- The fracture is confirmed by Gore using standard X-ray or angiographic images provided by the patient’s physician
Note that the device is intended to improve luminal diameter in patients with symptomatic de-novo, restenotic lesions, or occlusions in the native superficial femoral artery (SFA) and proximal popliteal artery (PPA). Use within the scope of the IFU includes, but is not limited to:
- Placement of the device such that the edges of the stent do not extended proximally past the SFA or distally beyond the PPA.
- Device sizing in accordance with the IFU (5-20% oversizing) which can be confirmed with implantation images or with the image of the suspected fractured device.
- Please see the IFU for further information on the specific contraindications, warnings, precautions, and potential adverse events for this device.
No refund under this program shall be available if a direct replacement device has already been provided, different substitute device(s) have already been provided, or Gore has refunded the cost of the device for other reasons.
Claims under the program are limited to percentage costs of the device. The amount of the refund shall be based on the list price for the same device (length and size) at the time the fracture is reported. The total amount of the refund paid to the hospital shall be equal to fifty percent (50%) of the device list price at the time the claim is made.
The amount of the refund is intended to allow hospitals to comply with Medicare reporting obligations; specifically requirements to return to Medicare any portion of a refund greater than fifty percent (50%) of the device cost. The requesting hospital shall be responsible for accurately recording and reporting the refund as a discount on the hospital’s cost report, whether submitted to federal health care programs (in accordance with the rules governing the applicable federal health care programs), or to other third parties.
Refunds made pursuant to the program will be accompanied by a no-charge debit invoice sent directly to the hospital upon confirmation by Gore of the fracture. All reports of frame fractures will be documented appropriately within the Gore internal product surveillance process and additional information about the reported fracture may be requested. Gore shall have sole discretion to determine whether a device frame fracture has occurred and may rely on a qualified third party laboratory to confirm the presence or absence of a fracture.
Any hospital or physician requesting a refund under the refund program shall agree to the terms and conditions described herein. The terms and conditions of the refund program shall be incorporated by reference into the existing medical device purchase or sales agreements between Gore and the requesting party. The parties further agree that the offer of the refund program is not made to otherwise induce or improperly influence the use of the device or other Gore medical products. Hospitals who stock or use the device agree that they will not make any specific communications about the refund program to physicians performing surgeries in the hospital encouraging or requiring the use of the device or other Gore medical products.
The offer of a refund under the program does not constitute an admission or evidence of any device malfunction, or defect, or that Gore, its employees or agents, or the Gore device caused or contributed to the patient’s complications, injuries, or death. Further, the device refund program does not constitute a warranty or guarantee, whether expressed or implied. Except as provided herein, and by law, Gore shall not be liable for any claims, actions, or benefits under the refund program.
The program is subject to modification or termination by W. L. Gore & Associates without prior notification and the program is only applicable for the United States. Contact your Gore Field Sales Associate for program details.