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

Model Number VBJR082502A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/30/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 295128777
• Report Number: 2017233-2022-03089
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132623693
• UDI-Public: 00733132623693
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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 Model Number: VBJR082502A
• Device Catalogue Number: VBJR082502A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 07/01/2022
• Supplement Dates Manufacturer Received: 06/10/2022
• Supplement Dates FDA Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization