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

Model Number VBJR060502A

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

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

The following was reported to gore: on october the patient presented for sfa occlusive disease.During the procedure a gore® viabahn® endoprosthesis snagged on a previously placed stent (brand unknown) and began to partially pre-deploy.The device was removed from the patient.Another gore device was used to complete the procedure.The patient tolerated the procedure.

Manufacturer Narrative

Engineering evaluation: the manufacturing records were reviewed and the device lot met all pre-release specifications.The physical investigation of the device confirmed the physician¿s observation that the zipper was partially deployed.It did not confirm the observation that the endoprosthesis had expanded.The root cause for the partially deployed zipper is consistent with interaction with a previously implanted device.

Manufacturer Narrative

This report was initially sent as a reportable malfunction, due to the stent graft being reported as partially expanded.However, the device was returned to gore for engineering evaluation.The engineering evaluation did not confirm, the observation that the endoprosthesis had expanded.As a result this medwatch will be retracted.

• 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: 10857073
• MDR Text Key: 222936620
• Report Number: 2017233-2020-01452
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132623952
• UDI-Public: 00733132623952
• 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: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: VBJR060502A
• Device Catalogue Number: VBJR060502A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/30/2021
• Patient Sequence Number: 1