GORE VIABAHN Endoprosthesis VBC081002Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132614608), received between Dec 24, 2018 and Dec 24, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

• InjuryDec 24, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED TO GORE THAT A 8MM X 10CM GORE® VIABAHN® ENDOPROSTHESIS WAS TO BE IMPLANTED FOR TREATMENT OF THE SPLENIC ARTERY ANEURYSM. BECAUSE OF THE EXCESSIVELY TORTUOUS VESSELS, RESISTANCE WAS REPORTEDLY FELT DURING DEVICE ADVANCEMENT. THE SPLENIC ARTERY ANEURYSM WAS RUPTURED DUE TO THE EXCESSIVE FORCE USED DURING ATTEMPTS TO GET THE VIABAHN DEVICE TO TREATMENT SITE. THE CONSTRAINED GORE® VIABAHN® ENDOPROSTHESIS WAS RETRACTED OUT OF THE PATIENT. COILING WAS DONE TO STOP THE BLEEDING AND THE PATIENT WAS TRANSFERRED TO THE ICU FOR SURGICAL INTERVENTION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 8193428 ↗