GORE VIABAHN Endoprosthesis with Heparin VBJR071502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132623785), received between Dec 9, 2019 and Dec 9, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 9, 2019Premature Activation; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Premature Activation; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: THE GORE® VIABAHN® ENDOPROSTHESIS WAS TO BE USED IN THE LEFT EXTERNAL ILIAC. THE DOCTOR ELECTED TO USE AN UP AND OVER APPROACH THROUGH THE VERY TORTIOUS CALCIFIC ILIAC. ACCORDING TO THE SCRUB TECH, WHEN THE GORE® VIABAHN® ENDOPROSTHESIS WAS REMOVED FROM THE PACKAGE SHE OBSERVED A KINK AT THE STENT, BUT THE DOCTOR CONTINUED TO USE THE DEVICE. THE DOCTOR DID NOT PREDILATE THE VESSEL. THE DEVICE FAILED TO ADVANCE TO THE LESION SO WAS REMOVED. DURING REMOVAL THE GORE® VIABAHN® ENDOPROSTHESIS PARTIALLY DEPLOYED AND CAME OFF THE CATHETER. THE DEVICE WAS REMOVED WITH THE SHEATH.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 9440085 ↗