GORE VIABAHN Endoprosthesis with Heparin VBHR110502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132646081), received between Apr 28, 2022 and May 22, 2024 — classified as 2 deaths, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON APRIL 25, 2024, A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE DEVICE), THREE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) AND A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WERE IMPLANTED DURING TREATMENT OF A COMMON ILIAC ARTERY ANEURYSM. DURING THE INITIAL CONTRAST RUN BLUSHING WAS IDENTIFIED OUTSIDE THE ARTERY. THE IBE DEVICE WAS SUCCESSFULLY IMPLANTED, A VBX DEVICE WAS SUCCESSFULLY IMPLANTED INTO THE FLOW DIVIDER OF THE IBE, TWO VBX DEVICES WERE PLACED AS EXTENSIONS ON ITHER SIDE. A VSX DEVICE WAS PLACED AS AN EXTENSION OF THE VBX DEVICE. A POST IMPLANT CONTRAST RUN WAS PERFORMED, AND EVERYTHING APPEARED TO BE GOOD. HOWEVER, SHORTLY AFTER THE PATIENT'S BLOOD PRESSURE DROPPED, AND THE PHYSICIAN SUSPECTED THAT THE AORTA HAD RUPTURED AND ATTEMPTED AN AORTIC BYPASS WITH A NONE GORE DEVICE. DURING THE ATTEMPTED AORTIC BYPASS, THE PATIENT EXPIRED. PRIOR TO THE PROCEDURE, ON AN UNKNOWN DATE THE PATIENT WAS IMPLANTED WITH A BARE METAL STENT IN THE ABDOMINAL AORTA. THE REASON FOR THE TREATMENT WAS UNKNOWN.

  Patient problems: Clinical Endoleak

  MAUDE report 19373413 ↗
• InjurySep 21, 2023Device Stenosis; Device Stenosis

  ON (B)(6) 2023, A PATIENT UNDERWENT MULTIPLE SURGERIES DUE TO TRAUMA. A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS USED IN THE RIGHT COMMON ILIAC ARTERY. ON (B)(6) 2023 THE PATIENT UNDERWENT A RELINING PROCEDURE BECAUSE THE VIABAHN DEVICE HAD BECOME THROMBOSED. THE DEVICE WAS LINED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS ILIAC EXTENDER. REPORTEDLY, HEPARIN-INDUCED THROMBOCYTOPENIA (HIT) WAS SUSPECTED BY THE PHYSICIAN ON (B)(6) 2023. THE PHYSICIAN DID NOT THINK THE HIT WAS CAUSED BY THE VIABAHN DEVICE. IT WAS REPORTED THE PATIENT IS DOING FINE AFTER THE RELINING PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17789712 ↗
• DeathMay 4, 2022Material Fragmentation; Activation Problem; Material Fragmentation; Activation Problem

  THE FOLLOWING INFORMATION WAS PROVIDED TO GORE: ON (B)(6) 2022, A GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE (VSX DEVICE) WAS INTENDED FOR USE IN THE POPLITEAL ARTERY FOR TREATMENT OF AN ANEURYSM. AFTER AN 11MM X 10CM VSX DEVICE WAS SUCCESSFULLY IMPLANTED, AN ADDITIONAL 11MM X 5CM VSX DEVICE WAS TO BE IMPLANTED AT THE DISTAL END OF THE FIRST DEVICE. REPORTEDLY THE DEPLOYMENT LINE WAS DIFFICULT TO PULL AND AFTER A FEW ATTEMPTS THE DEPLOYMENT LINE CAME OUT. HOWEVER, AFTER AN ANGIOGRAM WAS PERFORMED, IT WAS OBSERVED THE DEPLOYMENT LINE BROKE AND APPROXIMATELY HALF THE VSX DEVICE REMAINED CONSTRAINED. THE DELIVERY CATHETER WAS PULLED TO THE INTRODUCER SHEATH AND THE PHYSICIAN ATTEMPTED TO REMOVE THE SHEATH AND CATHETER IN TANDEM BY PULLING UP AND OVER THE AORTIC BIFURCATION. HOWEVER, THE VSX DEVICE HAD BECOME STUCK AT THE INCISION SITE AND A CUT DOWN WAS PERFORMED TO REMOVED THE VSX DEVICE. AFTER THE VSX DEVICE WAS REMOVED AND THE FINAL SUTURES WERE 3 BEING PLACED, THE PATIENTS VITALS DROPPED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED. THE PATIENT WAS BROUGHT TO THE INTENSIVE CARE UNIT (ICU) AND PLACED ON A VENTILATOR. IT WAS REPORTED THAT THE PATIENTS FAM

  Patient problems: Aneurysm

  MAUDE report 14274269 ↗
• MalfunctionApr 28, 2022Entrapment of Device

  PATIENT WENT FOR A LEFT LEG ANGIOGRAM AND STENT PLACEMENT. DURING THE PROCEDURE ONE OF THE STENTS ONLY PARTIALLY DEPLOYED AND WAS REMOVED BUT GOT LODGED AT THE RIGHT COMMON FEMORAL ARTERIOTOMY NECESSITATING A CUTDOWN. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 14257471 ↗