MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Catalog Number VBJR061502A

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 01/23/2019

Event Type  Injury  

Event Description

On (b)(6) 2016, this patient was implanted with a gore® viabahn® endoprosthesis to treat an in-stent restenosis in the left superficial femoral artery.On (b)(6) 2019, the patient presented with pain at rest in the lower left leg.On (b)(6) 2019, an angiogram of the left lower leg was performed.A repeat intervention was performed; however, details were not provided.

Manufacturer Narrative

H10/11: additional manufacturer narrative/corrected data - h6: conclusion code: 4315.Additional information was received: patient underwent a left femoral-popliteal above knee bypass on (b)(6) 2019 to treat the critical limb ischemia.The ischemia was resolved with the treatment.

Manufacturer Narrative

H10/11: additional manufacturer narrative/corrected data.After further review, this event classifies as a well-known event, as the event involves thrombosis, stenosis, re-stenosis, or loss of patency including partial and total occlusion in peripheral arterial disease (pad) and arteriovenous applications occurring greater than 30 days post implant.Therefore, this report is retracted.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8377839
• MDR Text Key: 137398341
• Report Number: 2017233-2019-00115
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623747
• UDI-Public: 00733132623747
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: VBJR061502A
• Device Lot Number: 15172136
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/12/2019; 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 55