VALIANT® Captivia VAMC3232C100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994797476), received between Aug 12, 2019 and Aug 12, 2019 — classified as 1 death.

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.

• DeathAug 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS ALSO IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM APPROXIMATELY EIGHT MONTHS LATER. IT WAS REPORTED VIA TECHNICAL SERVICES BY THE PATIENT'S SON THAT THE PATIENT¿S STENT GRAFT HAS ¿BURST¿ AND THE PATIENT HAD DIED FOUR YEARS THREE MONTHS POST THE IMPLANTATION OF THE VALIANT CAPTIVIA STENT GRAFT SYSTEM. THE CALLER REPORTED THAT THE PHYSICIAN WAS GOING TO REPORT THE INCIDENT TO THE FDA ASA DEVICE FAILURE. THE CALLER HAS NOT SPOKEN TO THE PHYSICIAN SINCE THE EVENT OCCURRED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death; Rupture

  MAUDE report 8883383 ↗