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

Model Number	VBJR060502A
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
Additional 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
• 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: 10857073
• Report Number: 2017233-2020-01452
• Device Sequence Number: 4169011
• Product Code: NIP
• UDI-Device Identifier: 00733132623952
• UDI-Public: 00733132623952
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 08/30/2021

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: 07/01/2023
• Device Model Number: VBJR060502A
• Device Catalogue Number: VBJR060502A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 06/30/2021; 08/30/2021
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 06/30/2021; 08/30/2021
• Patient Sequence Number: 1