VALIANT® Captivia VAMC4040C200TURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169346741), received between Jun 6, 2023 and Jun 6, 2023 — 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.

• InjuryJun 6, 2023Leak/Splash; Leak/Splash

  VALIANT CAPTIVA STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 320MM TYPE A AORTIC DISSECTION. DEBRANCHING OF THE ARCH WAS ALSO PERFORMED WITH THE TEVAR. THE DISSECTION HAD BEEN DIAGNOSED THREE YEARS PREVIOUSLY.  IT WAS REPORTED ON THE DATE OF THE CT , A TYPE III ENDOLEAK WAS IDENTIFIED. INTERVENTION WAS PERFORMED TWO DAYS LATERON THE (B)(6) 2023. IN OR AN ANGIOGRAM WAS PERFORMED WHICH CONFIRMED THE TYPE III ENDOLEAK. THE GRAFT WAS THEN RELINED WITH VAMC4440C150TU AND V AMC4242C200TU COVERING ALL THE OVERLAPS FROM THE PREVIOUS GRAFTS. THE FINAL ANGIOGRAM SHOWED NO TYPE III ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE TYPE III ENDOLEAK COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 17069208 ↗