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

Model Number VBJR081502A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Occlusion (1984)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

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

The following information was reported to gore: on (b)(6) 2020, the patient was treated for stenotic occlusion in the superficial femoral artery using two gore® viabahn® endoprostheses.It was reported both devices were delivered in their intended location without issue.On the same date, post operation, occlusion of the devices was identified.The physician stated the suspected cause of the occlusions is unknown.A reintervention was performed to treat the stenosis.The patient tolerated the procedure.

Manufacturer Narrative

Added h6 investigation findings and investigation conclusion.

• 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: 10950545
• MDR Text Key: 219957574
• Report Number: 2017233-2020-01500
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132623839
• UDI-Public: 00733132623839
• Combination Product (y/n): Y
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

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: No Information
• Device Expiration Date: 11/05/2022
• Device Model Number: VBJR081502A
• Device Catalogue Number: VBJR081502A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 12/05/2020
• Supplement Dates Manufacturer Received: 11/06/2020
• Supplement Dates FDA Received: 04/29/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention