GORE VIABAHN Endoprosthesis with Heparin VBJR060702ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132624096), received between Oct 9, 2020 and Oct 23, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (2 reports).

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.

• InjuryOct 23, 2024Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ON (B)(6) 2024, A PATIENT UNDERWENT A PROCEDURE FOR STENOSIS WHERE A 6 MM X 7.5 CM GORE® VIABAHN® ENDOPROSTHESIS (GORE® VIABAHN® DEVICE) WAS INTENDED TO BE USED IN THE RIGHT EXTERNAL ILIAC ARTERY. THE PATIENT WAS ORIGINALLY SCHEDULED FOR A FEMORAL-FEMORAL ARTERY BYPASS SURGERY BEFORE THIS PROCEDURE. THE PHYSICIAN WAS ATTEMPTING TO IMPROVE OUTFLOW. IT WAS REPORTED THE LESION WAS NOT PRE-DILATED. THE PHYSICIAN ADVANCED THE DELIVERY CATHETER USING AN ARROW-FLEX INTRODUCER SHEATH (SIZE UNKNOWN) OVER AN 0.014" IRONMAN GUIDE WIRE TO THE TARGET TREATMENT ZONE. REPORTEDLY, THERE WAS NO RESISTANCE NOTICED DURING ADVANCEMENT OF THE DELIVERY CATHETER. DURING DEPLOYMENT, THE LINE WAS PULLED, AND 90% OF THE STENT WAS EXPANDED BEFORE THE DEPLOYMENT LINE BECAME STUCK LEAVING 10% OF THE ENDOPROSTHESIS CONSTRAINED. AN ATTEMPT WAS MADE UNSUCCESSFULLY TO TRY TO PULL THE DEPLOYMENT LINE AGAIN WHILE SLIGHTLY PUSHING IN ON THE CATHETER AND ROTATING IN BOTH DIRECTIONS. A SURGEON WAS CALLED INTO THE SURGICAL SUITE. THE MEDICAL TEAM MADE THE DECISION TO TRY TO PULL AGAIN WITH MORE FORCE, THEY FELT NO INJURY COULD HAPPEN AT THAT POINT. THE DEPLOYMENT LINE WAS PULLED FORCEFULLY AND THE LINE BROKE. THERE WAS

  Patient problems: Insufficient Information

  MAUDE report 20517746 ↗
• MalfunctionApr 24, 2024Activation Problem; Activation Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON APRIL 10, 2024, A 6 MM X 7 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS INTENDED FOR USE AS A SNORKEL IN THE LEFT RENAL ARTERY FOR AN UNKNOWN ETIOLOGY. THE PHYSICIAN REPORTED THE PATIENT HAD EXTREME TORTUOSITY WITH AN ACCESS SITE AT THE RIGHT BRACHIAL ARTERY TO THE TARGET TREATMENT SITE OF THE LEFT RENAL ARTERY. THE VIABAHN DEVICE WAS INTRODUCED THROUGH A 6 F COOK INTRODUCER SHEATH OVER A 0.018¿ CORDIS SV-5 STEERABLE GUIDEWIRE. THE PHYSICIAN REPORTED THE DEPLOYMENT LINE WAS STUCK AFTER APPROXIMATELY 6 INCHES WITH FAILURE TO INITIATE DEPLOYMENT. THE VIABAHN STENT GRAFT DID NOT EXPAND. THE VIABAHN DEVICE WAS REMOVED WITHOUT DIFFICULTY. IT WAS NOTED THE PHYSICIAN ATTEMPTED DEPLOYMENT OF THE VIABAHN DEVICE ON THE BACK TABLE AFTER REMOVED FROM THE PATIENT, AND IT SUCCESSFULLY DEPLOYED WITHOUT ISSUE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19175358 ↗
• InjuryOct 9, 2020Activation Failure; Activation Failure

  DURING TREATMENT OF A SUPERFICIAL FEMORAL ARTERY, THE PHYSICIAN ATTEMPTED TO DEPLOY A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE). AS REPORTED, THE DEPLOYMENT LINE WAS FULLY DEPLOYED AND REMOVED BUT THE VIABAHN DEVICE REMAINED PARTIALLY CONSTRAINED. FROM THE DISTAL END, THE PHYSICIAN ATTEMPTED TO BALLOON THE CONSTRAINED SECTION BUT THIS WAS NOT POSSIBLE. AS A RESULT, A CUT DOWN WAS MADE AT THE POPLITEAL ARTERY (ABOVE KNEE) IN ORDER TO REMOVE THE VIABAHN DEVICE. TO COMPLETE THE PROCEDURE, A LONGER VIABAHN DEVICE WAS THEN ADVANCED AND DEPLOYED WITH NO ISSUES.

  Patient problems: Failure of Implant; Perforation

  MAUDE report 10657788 ↗