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

Device Problem Complete Blockage (1094)

Patient Problem Ischemia (1942)

Event Date 12/09/2020

Event Type  Injury  

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 an unknown date, a patient underwent endovascular treatment of a superficial femoral artery using a gore® viabahn® endoprosthesis.On an unknown date, acute limb ischemia (ali) wa discovered.A thrombectomy was performed surgically.Some time after the thrombectomy, a wound infection and a pseudoaneurysm rupture were observed.A new gore® viabahn® endoprosthesis was implanted.However the patient continued to exhibit infection and ali.Therefore, a major amputation was performed on an unknown date.

Event Description

The following was reported to gore; on an unknown date, a patient underwent endovascular treatment of a superficial femoral artery for peripheral artery disease using a gore® viabahn® endoprosthesis.The device was patent following the procedure.On an unknown date, following the initial procedure, acute limb ischemia (ali) wa discovered.A thrombectomy was performed surgically.On an unknown date after the thrombectomy, a wound infection in an unknown location and a pseudoaneurysm rupture were observed.A second gore® viabahn® endoprosthesis was implanted to exclude the ruptured pseudoaneurysm and treat the occlusion of the initial vsx.The devices were patent at the end of the procedure.However the patient continued to exhibit infection of unknown location and ali.On an unknown date, the secondarily implanted vsx was found to be occluded.Therefore, a major amputation was performed on an unknown date.

Manufacturer Narrative

B.5.Updated.

• 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: 11109110
• MDR Text Key: 225319179
• Report Number: 2017233-2021-01570
• Device Sequence Number: 1
• Product Code: NIP
• 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
• Report Date: 07/23/2021

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 07/23/2021
• Patient Sequence Number: 1