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

Model Number VBJR081502A

Device Problem Activation Problem (4042)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2020

Event Type  malfunction  

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 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nick la fave ; 9285263030
• MDR Report Key: 9638401
• MDR Text Key: 191434626
• Report Number: 2017233-2020-00054
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132623839
• UDI-Public: 00733132623839
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR