VALIANT® Captivia VAMC2828C100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169347212), received between Apr 11, 2023 and Apr 11, 2023 — classified as 1 malfunction.

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.

• MalfunctionApr 11, 2023Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS INTENDED TO BE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 200MM DISSECTION.  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE DEVICE WAS UNPACKED AND THE SCRUB TECHNICIAN BEGAN PREPARING THE DEVICE.WHEN FLUSHING THE SIDE PORT , IT WAS NOTICED THAT SALINE WAS NOT RUNNING DOWN THE DEVICE AND A LEAKING SOUND COULD BE HEARD. ANOTHER VALIANT CAPTIVA STENT GRAFT WAS IMPLANTED INSTEAD AND THE USE OF THIS STENT GRAFT WAS ABANDONED.  NO CAUSE OF THE EVENT WAS PROVIDED AS THE HCP WAS NOT PRESENT AND WAS NOT AWARE OF THE ISSUE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16711519 ↗