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

Model Number	VBJR082502A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No patient specific details have been provided, therefore the wl gore internal case number is being used as the patient identifier.Cbas® heparin surface incorporates carmeda 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 (b)(6) 2022 a patient presented for treatment of a superficial femoral artery (sfa) utilizing four gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn) devices.The patient had a large aneurysm (approximately 5cm) present in an sfa graft that was treated by open surgical procedure below the knee.The aneurysmal graft was relined with four viabahn devices.Follow up approximately one week later revealed all devices were patent and good blood flow was maintained.The following week, the physician reported that outflow had been lost and the leg had to be amputated.It was reported that all viabahn devices had remained open, and loss of blood flow was attributed to occlusion in the distal popliteal and peroneal arteries.There was no allegation that the viabahn devices did not perform as intended, and amputation was due to other factors.On an unknown day during the week of (b)(6) 2022 ((b)(6) used as event date), the physician reported the patient had to return due to an externally visible viabahn device in the distal portion of the leg.This was the first viabahn device implanted in the initial procedure on (b)(6) (a vbjr082502a device).The patient underwent a surgical procedure for repair.The patient tolerated the procedure and is reported to be recovering well.The physician noted that the intact proximal viabahn likely saved the patient from bleeding to death.He also attributed the exposed viabahn to potentially poor skin tissue in that area of the patients leg.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: kaitlin barnash ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14886561
• Report Number: 2017233-2022-03089
• Device Sequence Number: 12311274
• Product Code: NIP
• UDI-Device Identifier: 00733132623693
• UDI-Public: 00733132623693
• 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
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2022

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?: No
• Device Expiration Date: 08/30/2024
• Device Model Number: VBJR082502A
• Device Catalogue Number: VBJR082502A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown