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

Model Number	VBJR081502A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Added h6 investigation findings and investigation conclusion.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10950545
• Report Number: 2017233-2020-01500
• Device Sequence Number: 3317365
• Product Code: NIP
• UDI-Device Identifier: 00733132623839
• UDI-Public: 00733132623839
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Expiration Date: 11/05/2022
• Device Model Number: VBJR081502A
• Device Catalogue Number: VBJR081502A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 04/29/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention