VALIANT® Captivia VAMC3026C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169346895), received between Mar 31, 2023 and Mar 31, 2023 — 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.

• DeathMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE EMERGENT ENDOVASCULAR TREATMENT OF A RUPTURED 56MM TAA. IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT GRAFT VAMF2026C150 CAME BACK UNEXPECTEDLY WHILE DEPLOYING AND IT DIDN'T LAND IN ITS INTENDED LOCATION. THREE OTHER VALIANT CAPTIVIA'S WERE ALSO IMPLANTED DURING THE PROCEDURE. THE PATIENT THEN EXPIRED AND DIDN'T SURVIVE THE PROCEDURE. THE CAUSE OF THE INACCURATELY DELIVERY OF THE STENT GRAFT IS UNKNOWN. THE PATIENT DIED DUE TO THE RUPTURED TAA. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Ruptured Aneurysm

  MAUDE report 16655472 ↗