VALIANT® Captivia VAMC3030B100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169346468), received between Jun 28, 2018 and Jun 28, 2018 — classified as 1 injury.

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 16, 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.

• InjuryJun 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. DURING THE INDEX PROCEDURE, IT WAS REPORTED THAT THE LEFT EXTERNAL ILIAC WAS RUPTURED WITH A PTA BALLOON, THE PATIENT WAS THEN TREATED SUCCESSFULLY. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO ANATOMY AND THE ILIAC RUPTURE WAS NOT RELATED TO THE VALIANT STENT GRAFT.

  Patient problems: Perforation of Vessels

  MAUDE report 7647653 ↗