VALIANT® Captivia VAMC2424C100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994797513), received between Nov 7, 2017 and Nov 7, 2017 — classified as 1 death.

The most frequently reported specific device problem is “Leak/Splash” (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 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.

• DeathNov 7, 2017Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. CT EXAM SHOWED A TYPE III ENDOLEAK "WITH PROBABLE DISLOCATION OF AORTIC STENT." ADDITIONAL STENT GRAFTS WERE PLACED AND THE LEAK WAS RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury; Pain

  MAUDE report 7005502 ↗