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

Model Number	VBJR060702A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Failure of Implant (1924); Perforation (2001)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.
Additional Manufacturer Narrative
D1 - product name was corrected.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10657788
• Report Number: 2017233-2020-01343
• Device Sequence Number: 3243415
• Product Code: NIP
• UDI-Device Identifier: 00733132624096
• UDI-Public: 00733132624096
• Combination Product (Y/N): Y
• Initial Reporter State: WV
• 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,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/23/2022
• Device Model Number: VBJR060702A
• Device Catalogue Number: VBJR060702A
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 09/16/2020; 09/16/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 03/09/2021; 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR