MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; NIP / STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number PAHR062502E

Device Problems Partial Blockage (1065); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stenosis (2263); Restenosis (4576)

Event Date 09/28/2022

Event Type  Injury  

Manufacturer Narrative

W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

It was reported to gore, that on (b)(6) 2022, the patient presented with peripheral artery disease and restenotic lesions in the superficial femoral artery (sfa) and proximal popliteal artery on the patients right.The lesion was treated with three gore® viabahn® endoprosthesis and two medtronic everflex¿ self-expanding peripheral stents.It was stated that the lesion originated in the beginning of the sfa and ended at least 1 cm above the intercondylar notch.On (b)(6) 2022 a restenosis of the popliteal artery was identified and successfully treated on (b)(6) 2022, with a reintervention using antiplatelet/anticoagulant medication.It was indicated that the restenosis was disease related.

Event Description

It was reported to gore, that on (b)(6) 2022, the patient presented with peripheral artery disease and restenotic lesions in the superficial femoral artery (sfa) and proximal popliteal artery on the patients right.The lesion was treated with three gore® viabahn® endoprosthesis and two medtronic everflex¿ self-expanding peripheral stents.It was stated that the lesion originated in the beginning of the sfa and ended at least 1 cm above the intercondylar notch.On (b)(6) 2022, a restenosis of the popliteal artery was identified and successfully treated on (b)(6) 2022, with a reintervention using antiplatelet/anticoagulant medication.It was indicated that the restenosis was disease related.

Manufacturer Narrative

H6: code b14 and c19: a review of the manufacturing records indicated the device met pre-release specifications.H6: code b13: additional information to the event has been requested and were provided.The provided information was captured in the event description.H6: code d12 - in the instructions for use the following is stated: adverse events: possible adverse events and complications that may occur with the use of any gore® viabahn® endoprosthesis with propaten® bioactive surface or in any endovascular procedure and require intervention include, but are not limited to: occlusion (thrombosis and/or stenosis) of endoprosthesis or vessel.C1: cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: NIP / STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: kerstin haberlaender ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16041589
• MDR Text Key: 306065394
• Report Number: 2017233-2022-03600
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: SW
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PAHR062502E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 73 KG