GORE VIABAHN Endoprosthesis VBC130502Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132614745), received between Sep 26, 2018 and Sep 26, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2018Material Fragmentation; Separation Failure; Difficult or Delayed Activation; Material Fragmentation; Separation Failure; Difficult or Delayed Activation

  IT WAS REPORTED TO GORE THAT A 13MM X 5CM GORE® VIABAHN® ENDOPROTHESIS WAS TO BE IMPLANTED FOR TREATMENT OF DISSECTION OF THE RIGHT COMMON ILIAC ARTERY. DURING DEPLOYMENT, A RESISTANCE WAS REPORTEDLY FELT ON PULLING THE DEPLOYMENT LINE. THE DEVICE WAS ABLE TO DEPLOY AND EXPAND COMPLETELY WITH EXTRA FORCE. HOWEVER, THE DEPLOYMENT LINE GOT STUCK ON THE NITINOL STENT TO RELEASE FROM THE CATHETER. THE PHYSICIAN EVER ATTEMPTED TO RELEASE THE DEPLOYMENT LINE BY USING A CATHETER AND A BALLOON, BUT ALL FAILED. FINALLY THE PHYSICIAN INSERTED A COOK DCHN PUNCTURE NEEDLE TO CUT THE DEPLOYMENT LINE AND THE CATHETER WAS ABLE TO RETRACT OUT OF THE PATIENT. ABOUT 10CM DEPLOYMENT LINE BEING CONNECTED TO THE VIABAHN DEVICE WAS LEFT INSIDE THE PATIENT. THE PHYSICIAN CONCERNED THE FRAGMENT OF DEPLOYMENT LINE INSIDE THE PATIENT MIGHT CAUSE A THROMBOSIS OF THE COMMON ILIAC ARTERY, A BARE STENT WAS IMPLANTED TO PIN THE FRAGMENT OF DEPLOYMENT LINE AGAINST THE VESSEL WALL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7913082 ↗