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

Catalog Number	VBJR050702A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of device manufacturing record history confirmed device met pre-release specifications.The engineering evaluation state only the deployment knob, deployment line and delivery catheter were returned.There was approximately 85.5 cm of deployment line between the hub and deployment knob.The dual lumen was kinked approximately 30 and 84 cm from the hub.The remainder of the device was unremarkable.Based on the device examination performed, no manufacturing anomalies were identified.
Event or Problem Description
The following was reported to gore: patient presented for an axillo-femoral procedure.Also planned was treatment for the femoro-popliteal artery.As reported, patient has peripheral artery disease with pre-existing stents in the femoro-popliteal artery.It is unknown if the target lesion was pre-dilated.A 7fr cook ansel sheath was used to advance a gore® viabahn® endoprosthesis over a.018 nitrex guidewire.The viabahn device was placed at the target lesion and deployment was initiated.However, after about 2 cm of device expansion, the line became stuck and the delivery catheter started bowstringing.The physician was able to pull the partially expanded device back into sheath.The device was withdrawn and a new viabahn device was used to complete the procedure with good outcome.The patient did not experience any adverse consequences.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8692490
• Report Number: 2017233-2019-00412
• Device Sequence Number: 19334427
• Product Code: PFV
• UDI-Device Identifier: 00733132624089
• UDI-Public: 00733132624089
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• 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): 05/14/2019

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: 04/02/2022
• Device Catalogue Number: VBJR050702A
• Device Lot Number: 20542890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• 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: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 74