VALIANT® Captivia VAMC2824C150TU (UDI 00613994802835)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994802835), received between Oct 31, 2019 and Oct 31, 2019 — classified as 1 injury.

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 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.

• InjuryOct 31, 2019Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT FOLLOW UP CT ON AN UNKNOWN DATE SHOWED WHAT APPEARED TO BE A TYPE III ENDOLEAK. IT WAS REPORTED THAT THE ENDOLEAK WAS THOUGHT TO BE A TYPE IIIB ENDOLEAK AS THERE WERE NO MARKERS AT THE TOP OF THE SEPARATED PIECE AND THE DISTAL GRAFT THAT HAD SEPARATED WAS ONLY APPROX. 6CM IN LENGTH. A RE-INTERVENTION PROCEDURE WAS CARRIED OUT APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE AND A VALIANT NAVION STENT GRAFT VNMC2828C182TU WAS IMPLANTED TO COVER THE ENDOLEAK. NO FURTHER ISSUES REPORTED AND THERE WAS NO ENDOLEAK SEEN AT THE END OF THE PROCEDURE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO THE PATIENT¿S TORTUOUS DISTAL AORTA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9259297 ↗