GORE VIABAHN Endoprosthesis with Heparin VBJR082502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132623693), received between Jul 1, 2022 and Jul 16, 2024 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2024Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: DURING TREATMENT OF A STENOSIS IN THE PATIENT'S SUPERFICIAL FEMORAL ARTERY, ACCESS WAS MADE FROM THE CONTRALATERAL SIDE. AS REPORTED, THERE WERE EXISTING DEVICES AT THE AORTIC BIFURCATION, BUT NOT AT THE INTENDED TREATMENT AREA. AN 8FR DESTINATION SHEATH WAS USED TO ADVANCE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) OVER AN 0.018 GRAND SLAM WIRE. THE VIABAHN DEVICE REACHED THE INTENDED TREATMENT AREA AND DEPLOYMENT WAS INITIATED. THE DEPLOYMENT LINE BECAME STUCK AFTER ABOUT A THIRD OF THE VIABAHN DEVICE EXPANDED. THE DEPLOYMENT LINE COULD NOT BE RELEASED ANY FURTHER. CONSEQUENTLY, A 12FR X 80CM COOK SHEATH WAS INSERTED FROM THE CONTRALATERAL SIDE, AND THE SHEATH WAS USED TO COVER THE PARTIALLY EXPANDED DEVICE. THE VIABAHN DEVICE AND SHEATH WERE THEN REMOVED TOGETHER. THE PROCEDURE CONTINUED WITH DEPLOYMENT OF TWO ADDITIONAL VIABAHN DEVICES. AS REPORTED, THE PROCEDURE TIME WAS PROLONGED DUE TO THE EXTRA MEASURES TAKEN TO REMOVE THE PARTIALLY EXPANDED VIABAHN DEVICE. THE PROCEDURE ENDED WITH GOOD RESULTS AND THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THE PHYSICIAN DID NOT HAVE AN OPINION OF WHY THE DEP

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19757487 ↗
• InjuryJul 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 VBJR082502

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14886561 ↗