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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pseudoaneurysm (2605)

Event Date 03/11/2020

Event Type  malfunction  

Event Description

On an unknown date in (b)(6) 2019, the patient underwent treatment for vein graft stenosis by performing pta ballooning and implanting a lifestent® vascular and biliary stent (lifestent, 6mm x 80mm).On (b)(6) 2020, the patient underwent treatment for stenosis in the previously implanted lifestent® using a gore® viabahn® endoprosthesis (vsx).The vsx device was placed within the lifestent® with the distal tip of the vsx device landing in the popliteal artery.On (b)(6) 2020 imaging identified the lifestent® had fractured and had torn in half creating a pseudoaneurysm.The vxs device reportedly compressed proximally, exposing the lifestent®.A re-intervention is planned to explant the device and perform a surgical bypass.

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

On an unknown date in(b)(6)2019, the patient underwent treatment for vein graft stenosis by performing pta ballooning and implanting a lifestent® vascular and biliary stent (lifestent, 6mmx80mm).¿ on (b)(6) 2020, the patient underwent treatment for stenosis in the previously implanted lifestent® using a gore® viabahn® endoprosthesis (vsx).The vsx device was placed within the lifestent® with the distal tip of the vsx device landing in the popliteal artery.On (b)(6) 2020 imaging identified the lifestent® had fractured and had torn in half creating a pseudoaneurysm.¿the vxs device reportedly compressed proximally, exposing the lifestent®.¿ no additional information from the account will be provided.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS
• 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: 10397856
• MDR Text Key: 207334009
• Report Number: 2017233-2020-01118
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 07/15/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization