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

Catalog Number VBJR081502A

Device Problem Activation Failure (3270)

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

Event Date 07/17/2019

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified the lot met all pre-release specifications.

Event Description

The following information was reported to gore: on (b)(6) 2019 a patient was undergoing treatment of a popliteal aneurysm with a gore® viabahn® endoprosthesis.Access was obtained via the contralateral femoral artery, in an up and over approach, with a short 7fr sheath over a.014" 300cm spartacus wire.The device was advanced to the target location.When deployment was attempted the endoprosthesis curled up like a snake and the deployment line was wrapped around the device, terminating expansion.The device had opened approximately 1-2cm.The device was removed from the vessel without apparent damage, however the procedure was converted to open bypass.The patient did well following the bypass procedure.

Manufacturer Narrative

H.6.Results code 2: 213: the engineering evaluation stated the following: the endoprosthesis, part of the delivery catheter and part of the deployment line were returned.The hub of the delivery catheter was not returned.A guidewire was returned, this was not evaluated as it is not a gore device.There was approximately 138 cm of deployment line returned with two single fibers coming from the end that measured approximately 14 and 8 cm long.The dual lumen was stretched in two locations.The first was approximately 12 cm from the hub end of the delivery catheter for about 4 cm.The second was approximately 34 cm from the hub end of the delivery catheter and was stretched for 23 cm.The distal shaft, upon which the endoprosthesis is mounted, was broken at the transition.Part of the distal shaft was visible within the transition.The endoprosthesis was partially expanded approximately 5 cm with approximately 9 cm of the endoprosthesis still constrained by the constraining line.There was body delamination as well as outwardly flared struts in the body of the endoprosthesis.Deployment was able to be continued with traction on the deployment line at the endoprosthesis.Based on the device examination performed, no manufacturing anomalies were identified which could be definitively attributed to the event.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8829358
• MDR Text Key: 152465555
• Report Number: 2017233-2019-00567
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623839
• UDI-Public: 00733132623839
• Combination Product (y/n): N
• 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: 08/07/2019

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: 01/29/2022
• Device Catalogue Number: VBJR081502A
• Device Lot Number: 20298126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 58 YR