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

Catalog Number JHH111002J

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Occlusion (1984)

Event Date 03/01/2020

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6) 2020, the patient underwent endovascular treatment of a pseudoaneurysm at the left subclavian artery using gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn).Two viabahn were placed and the procedure was completed without any issue.On (b)(6) 2020, the follow up ct imaging revealed blood clot inside the devices.The medication was changed from dapt (bayaspirin and plavix) to warfarin and aspirin.On (b)(6) 2020, it was observed that the stenosis due to blood clot inside the devices have been progressed.On (b)(6) 2020, reintervention was performed.Two additional stent grafts were placed inside the viabahns, and it was confirmed that no issue on the blood flow on the final angiography imaging.The procedure was completed, and the patient tolerated the procedure.

Manufacturer Narrative

A1: patient id: (b)(6).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.Mrn#: 2017233-2020-01479 is referencing the same patient and procedure as this report.

• 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: 10885818
• MDR Text Key: 217709159
• Report Number: 2017233-2020-01478
• 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: 09/13/2021

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: Health Professional
• Device Expiration Date: 12/28/2020
• Device Catalogue Number: JHH111002J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 11/02/2020
• Supplement Dates FDA Received: 09/13/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR