GORE VIABAHN Endoprosthesis VBC080502Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132614585), received between Dec 3, 2019 and Dec 3, 2019 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2019Activation Failure; Activation Failure

  IT WAS REPORTED TO GORE THAT A 8MM X 5CM GORE® VIABAHN® ENDOPROSTHESIS WAS TO BE IMPLANTED FOR TREATMENT OF THE RIGHT COMMON ILIAC ARTERY ANEURYSM. WHEN THE DEVICE WAS ADVANCED TO THE TARGET LESION, THE PHYSICIAN INITIATED THE DEPLOYMENT LINE. WHEN THE DEVICE WAS DEPLOYED AROUND 1-2CM, THE DEPLOYMENT LINE GOT STUCK AND COULD NOT BE DEPLOYED FURTHER. THEN THE PHYSICIAN RETRACTED THE DEVICE OUT OF THE PATIENT TOGETHER WITH THE DELIVERY SYSTEM AND THE PHYSICIAN USED THE BARD FLUENCY GRAFT TO COMPLETE THE PROCEDURE.THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Not Applicable

  MAUDE report 9407171 ↗