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

Model Number VBJR060702A

Device Problem Activation Failure (3270)

Patient Problems Failure of Implant (1924); Perforation (2001)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

Review of device manufacturing record history confirmed device met pre-release specifications.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.

Event Description

During treatment of a superficial femoral artery, the physician attempted to deploy a gore® viabahn® endoprosthesis (viabahn device).As reported, the deployment line was fully deployed and removed but the viabahn device remained partially constrained.From the distal end, the physician attempted to balloon the constrained section but this was not possible.As a result, a cut down was made at the popliteal artery (above knee) in order to remove the viabahn device.To complete the procedure, a longer viabahn device was then advanced and deployed with no issues.

Manufacturer Narrative

H6 - code 213: engineering evaluation states the following items were returned: the following items were returned and reviewed: 51.5cm of the delivery catheter, including the distal shaft, distal tip, deployment line, deployment knob, and partially deployed device.The evaluation confirms the complaint of partial deployment and finds the cause to be tensile failure of the deployment line.The ultimate cause of the broken deployment line cannot be further identified because deployment was able to be continued in the lab.A product history review was conducted for the viabahn stent graft.The manufacturing records were reviewed, and the device lot met all pre-release specifications.H6 - codes were updated.

Manufacturer Narrative

D1 - product name was corrected.

• 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: 10657788
• MDR Text Key: 210676389
• Report Number: 2017233-2020-01343
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132624096
• UDI-Public: 00733132624096
• 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,Followup
• Report Date: 04/06/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2022
• Device Model Number: VBJR060702A
• Device Catalogue Number: VBJR060702A
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 09/16/2020; 09/16/2020
• Supplement Dates FDA Received: 03/09/2021; 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR