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

Catalog Number PAJR071502E

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis (2100)

Event Date 12/29/2020

Event Type  Injury  

Manufacturer Narrative

The actual device involved in the adverse event is not readily accessible for testing (remains implanted in patient).Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

It was reported to gore that patient underwent endovascular treatment for a recurrent stenosis in the superficial femoral artery (sfa) with 2 gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn-device).It was stated that a ringstripping of the sfa and a thromboendarterectomy (tea) as well as a recanalization of the sfa and proximal popliteal artery was performed.Pre-dilation with a 5mm and 6mm balloon (although very distally approximately 5mm).It was reported that distally a viabahn-device was implanted with landing zone joint space knee.Then built towards proximal with another viabahn-device with landing zone approximately 5-6cm under the origin of the sfa with at least 1cm overlap between both devices.It was stated that post-dilation with a 6mm and 7mm pta balloon was performed and tea in the cfa with creation of a patch for a good inflow.The final angiogram result was fine.Heparin was induced during the procedure and a dual anti-platelet therapy performed (pradaxa en ascal) after the procedure.Reportedly after about 2 weeks the viabahn-device thrombosed.

Manufacturer Narrative

H6 evaluation codes investigation findings 213 refers to the phr-review: the review of the manufacturing and heparin coating process records indicated the device met pre-release manufacturing specifications.Investigation summary: the specific cause of this complaint could not be determined.Gore did not receive the explanted device, and conclusive information regarding the device form and the procedure was not available.The investigation confirms the complaint occlusion but is unable to assign cause.There are potential user, design, and process failure modes identified for which cause is possible, but no conclusion can be drawn because evaluation of the device was not possible.Further information from the implant procedure was provided by the field sales associate, but this information neither confirmed nor dismissed potential reasonably foreseeable misuses.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: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11235803
• MDR Text Key: 228856992
• Report Number: 2017233-2021-01628
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2022
• Device Catalogue Number: PAJR071502E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR