GORE VIABAHN Endoprosthesis with Heparin VBHR101502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132646067), received between Jul 17, 2023 and Jan 15, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2025Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: DURING TREATMENT OF A PATIENT'S LEFT POPLITEAL ARTERY ANEURYSM, ACCESS WAS MADE FROM THE RIGHT LEG, UP AND OVER THE BIFURCATION. AN 8FR TERUMO SHEATH WAS USED TO ADVANCE THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) OVER A 0.035 BENTSON WIRE. THE VIABAHN DEVICE WAS DELIVERED TO THE TREATMENT AREA. DEPLOYMENT WAS STARTED AND THE DEPLOYMENT LINE UNRAVELED TO THE DISTAL TIP, THEN THE DEVICE STARTED BOWSTRINGING DUE TO LINE TENSION. IT WAS REPORTED THE PHYSICIAN PULLED HARD ON THE DEPLOYMENT LINE, BUT THERE WAS NO FURTHER LINE DEPLOYMENT. THE GUIDEWIRE WAS EXCHANGED FOR AN AMPLATZ WIRE AND DEPLOYMENT LINE WAS PULLED ONCE MORE. THE VIABAHN DEVICE STILL CONTINUED TO BOWSTRING WITH A STUCK DEPLOYMENT LINE. THE VIABAHN DEVICE WAS WITHDRAWN FROM THE PATIENT WITH NO ISSUES. USING THE SAME AMPLATZ WIRE, A NEW VIABAHN DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. AS REPORTED, THE DEPLOYMENT LINE MAY HAVE BEEN WRAPPED AROUND THE DISTAL TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21160332 ↗
• InjuryJul 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS IMPLANTED IN AN OFF-LABEL PROCEDURE TO REPAIR A POPLITEAL ANEURYSM. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED FOR THE SIZING OF THE VIABAHN DEVICE. ON (B)(6) 2024, A REINTERVENTION OCCURRED IN WHICH AN ADDITIONAL VIABAHN DEVICE WAS ADDED TO EXTEND THE PROXIMAL PORTION OF THE VIABAHN DEVICE STENT GRAFT THAT WAS IMPLANTED ON (B)(6) 2024 DUE TO THROMBOSIS. THE PHYSICIAN REPORTEDLY PUT THE PATIENT ON ASPIRIN AND PLAVIX. THE PHYSICIAN DID NOT SUSPECT HEPARIN-INDUCED THROMBOCYTOPENIA (HIT). THE PHYSICIAN SUSPECTED THE EVENT WAS RELATED TO THE PATIENT IMMEDIATELY DOING PHYSICAL THERAPY AFTER THE (B)(6) 2024 PROCEDURE. THE PATIENT TOLERATED BOTH PROCEDURES AND IS DOING WELL.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19671035 ↗
• InjuryJul 17, 2023Fracture; Malposition of Device; Fracture; Malposition of Device

  ON (B)(6) 2023, A PATIENT UNDERWENT TREATMENT FOR AN ANEURYSM IN THE POPLITEAL ARTERY IN THE LEFT LEG UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE). IT WAS REPORTED THE PHYSICIAN PERFORMED USUAL RUNOFFS DETERMINING SUFFICIENT DISTAL RUNOFF AND TO DETERMINE THE LOCATION OF THE ANEURYSM. INTRAVASCULAR ULTRASOUND (IVUS) IMAGING WAS THEN PERFORMED TO SELECT THE VIABAHN DEVICE SIZE. REPORTEDLY, THE PROXIMAL VESSEL DIAMETER WAS 9 MM, THEREFORE A 10 MM X 15 CM VIABAHN DEVICE WAS SELECTED. REPORTEDLY, THE PHYSICIAN ACCESSED THE PATIENT CONTRALATERALLY VIA THE FEMORAL ARTERY. SINCE THE DEVICE REQUIRED AN 8F SHEATH, THE DECISION WAS MADE TO DEPLOY THE STENT WITHOUT A SHEATH OVER A .035" AMPLATZ GUIDE WIRE. THE STENT PASSED COMPLETELY INTO THE VESSEL, HOWEVER RESISTANCE WAS MET JUST PROXIMAL TO THE AORTIC BIFURCATION AND IT WOULD NOT ADVANCE ANY FURTHER. AN ATTEMPT TO WITHDRAW THE DEVICE WAS MADE. THE DELIVERY CATHETER WAS WITHDRAWN, BUT THE STENT-GRAFT WITH THE DEPLOYMENT LINE STILL ATTACHED REMAINED IN THE PATIENT'S COMMON ILIAC ARTERY. THE DECISION WAS MADE TO DEPLOY THE DEVICE. UNDER FLUOROSCOPY, IT WAS CONFIRMED THE STENT-GRAFT DEPLOYED SUCCESS

  Patient problems: Obstruction/Occlusion

  MAUDE report 17333574 ↗