VALIANT® Captivia VAMF2222C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169347038), received between May 2, 2025 and May 2, 2025 — classified as 1 death.

The most frequently reported specific device problem is “Positioning Problem” (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.

• DeathMay 2, 2025Positioning Problem; Positioning Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE INTENDED TO BE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A PAU . THE PAU WAS SUSPECTED TO BE INFECTED AND THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR 2 WEEKS. SURGERY PROCEEDED ONCE BLOOD RESULTS HAD NORMALIZED. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE VAMF2222C100TU WAS ATTEMPTED TO BE INSERTED VIA THE RIGHT ACCESS BUT THE DEVICE WOULD NOT ADVANCE. SHOCKWAVE THERAPY WAS THEN USED AND THE DEVICE INSERTION WAS ATTEMPTED AGAIN. THE DEVICE WOULD NOT ADVANCE PAST THE RIGHT COMMON ILIAC ARTERY. TWO OVERLAPPING NON-MDT 8MM STENTS WERE PLACED TO SPAN THE RIGHT COMMON ILIAC ARTERY. DESPITE FURTHER ATTEMPTS, INCLUDING SERIAL DILATION USING SEVERAL DILATORS ,THE LARGEST DILATOR USED WAS A 18 FR SENTRANT SHEATH WHICH HAD A OUTER DIAMETER COMPARABLE WITH THE DEVICE. ANOTHER ATTEMPT TO INSERT THE DEVICE WAS MADE BUT THIS WAS UNSUCCESSFUL. THE PHYSICIAN THEN IDENTIFIED A SMALL GAP BETWEEN THE NOSE CONE AND THE GRAFT COVER, PROMPTING A SWITCH TO THE VAMF2222C150TU WHICH WAS ALSO INSERTED INTO THE PATIENT BUT WOULD NOT ADVANCE. THE PHYSICIAN THEN ATTEMPTED TO FLUSH THE RIGHT ACCESS SHEATH AND NO BLOOD RETURNED. A DIAGNOSTIC ARTERIOGRAM REVEALED EXTR

  Patient problems: Disseminated Intravascular Coagulation (DIC); Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Myocardial Infarction; Perforation of Vessels

  MAUDE report 21949394 ↗