GORE VIABAHN Endoprosthesis with Heparin VBH131002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132623297), received between Jul 25, 2019 and Jun 19, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionJun 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO GORE: ON (B)(6) 2020 A PATIENT WAS BEING TREATED FOR A LEFT POPLITEAL SFA CUT DOWN USING A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN), THROUGH A MEDTRONIC 12FR SHEATH. THE PHYSICIAN PRE-DILATED THE TREATMENT AREA. WHILE THE PHYSICIAN WAS ADVANCING THE DELIVERY SYSTEM TO THE TREATMENT AREA HE NOTICED THE RADIOPAQUE MARKERS WERE OFF BY APPROXIMATELY 2 CM. THE FSA THEN SUGGESTED THE PHYSICIAN RETRIEVE THE DEVICE. THE PHYSICIAN CAREFULLY AND SLOWLY REMOVED THE DEVICE. WHEN THE DEVICE WAS CLEARED OF THE PATIENT IT WAS NOTED THAT THE DEVICE WAS SLIDING FREELY ON THE CATHETER. THE PHYSICIAN NOTED HE FELT A SLIGHT RESISTANCE AT FIRST, HOWEVER HE THOUGHT THE RESISTANCE WAS DUE TO THE PATIENT'S TORTUOUS ANATOMY. THE PROCEDURE WAS COMPLETED USING ANOTHER VIABAHN OF THE SAME SIZE. THE PATIENT TOLERATED THE PROCEDURE AND IS DOING WELL. THE DEVICE IS AVAILABLE FOR RETURN, A HISTO KIT HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10176828 ↗
• MalfunctionJan 14, 2020Separation Failure; Difficult to Open or Close; Separation Failure; Difficult to Open or Close

  THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT PRESENTED FOR AV FISTULA PSEUDOANEURYSM REPAIR. THE FIRST GORE® VIABAHN® ENDOPROSTHESIS WAS PLACED WITHOUT INCIDENT. THE SECOND GORE® VIABAHN® ENDOPROSTHESIS (OVERSIZED) WAS POSITIONED AND DEPLOYMENT STARTED. AS THE DEPLOYMENT LINE WAS BEING PULLED THE DEVICE APPEARED TO MOVE SO A GAP WAS CREATED BETWEEN THE TWO DEVICES. TO BRIDGE THE GAP THE DOCTOR SELECTED A THIRD GORE® VIABAHN® ENDOPROSTHESIS. THE THIRD GORE® VIABAHN® ENDOPROSTHESIS WAS ADVANCED INTO PLACE AND THE DEPLOYMENT LINE PULLED. THE DOCTOR PLACED HIS FINGER ON THE DEVICE AS THE RESIDENT SLOWLY PULLED THE DEPLOYMENT LINE. AFTER OPENING APPROXIMATELY 50%, THE DEPLOYMENT LINE TENSION STARTED TO INCREASE. AFTER APPROXIMATELY 95% DEPLOYMENT, THE DEPLOYMENT LINE STOPPED AND APPEARED TO BE STILL ATTACHED TO THE DEVICE. THE DOCTOR REMOVED THE CATHETER AND THREADED THE DEPLOYMENT LINE INTO ANOTHER CATHETER, THEN PULLED THE DEPLOYMENT LINE WHILE ADVANCING THE CATHETER, THUS THE DEVICE EVENTUALLY PARTIALLY OPENED. THE DOCTOR BALLOONED THE PARTIALLY OPENED DEVICE WITH NO SUCCESS SO COMPLETED THE PROCEDURE BY PLACING A BARE METAL STENT TO HOLD THE GORE® VIABAHN® ENDOPROSTHESIS OPEN. TH

  Patient problems: Fistula; Pseudoaneurysm

  MAUDE report 9589447 ↗
• MalfunctionJul 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019 A PATIENT WAS UNDERGOING TREATMENT OF A SUBCLAVIAN ARTERY ANEURYSM WITH GORE® VIABAHN® ENDOPROSTHESES. ACCESS WAS OBTAINED USING A 12FR SHEATH OVER AN AMPLATZ WIRE. A 10 MM X 5 CM GORE® VIABAHN® ENDOPROSTHESIS WAS ADVANCED AND DEPLOYED. THEN A 13 MM X 10 CM DEVICE WAS ADVANCED. DEPLOYMENT WAS INITIATED, BUT WHEN THE DEPLOYMENT LINE WAS PULLED, THE LINE CAME ALL THE WAY OUT WITHOUT COMPLETING DEVICE EXPANSION. THE CONSTRAINED SECTION OF THE ENDOPROSTHESIS WAS WITHIN THE 10 MM X 5 CM DEVICE. THE DELIVERY CATHETER WAS CUT TO TRY TO EXPOSE ANY REMAINING LINE. THE ENDOPROSTHESIS WAS STUCK TO THE CATHETER IN A TANGLED MANNER. IT WAS NOT POSSIBLE TO RETRACT THIS DEVICE. THROUGH SOME MANEUVERS THE DEVICE WAS PUSHED AND PULLED, BUT THE CONSTRAINED PORTION OF THE ENDOPROSTHESIS BROKE FREE AND FLOATED INTO THE ANEURYSM SAC. THE REMAINDER OF THE DEVICE WAS RE-SHEATHED AND REMOVED. ANOTHER 13 MM X 5 CM DEVICE WAS ADVANCED AND DEPLOYED, FOLLOWED BY A 13 MM X 5 CM DEVICE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8829337 ↗