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

Model Number	VBJR081502A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the manufacturing records indicated the device met pre-release specifications.No device or images were provided to gore for evaluation.Therefore, based on the engineering evaluation performed, no root cause was identified.
Event or Problem Description
The following was reported to gore: on (b)(6) 2020 the patient presented with thrombosis in the brachial artery.An 8mm x 15cm gore® viabahn® endoprosthesis was to be deployed as a brachial artery to brachial vein fistula.However, during deployment, the device started to "bowstring" and would not deploy after approximately 1cm of the device was expanded.The device was removed and an 8mm x 15cm gore® viabahn® endoprosthesis was successfully deployed to complete the procedure.The patient tolerated the procedure and is doing well.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9638401
• Report Number: 2017233-2020-00054
• Device Sequence Number: 14082576
• Product Code: NIP
• UDI-Device Identifier: 00733132623839
• UDI-Public: 00733132623839
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/03/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2022
• Device Model Number: VBJR081502A
• Device Catalogue Number: VBJR081502A
• Device Lot Number: 20894842
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR