VALIANT® Captivia VAMC3636C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169346857), received between Nov 3, 2020 and Jun 18, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2024Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  A VALIANT CAPTIVIA VAMC3636C150TU STENT GRAFT WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 70MM TAA . IT WAS NOTED THAT THE PATIENT HAD A PREVIOUS ASCENDING ARCH REPAIR WITH A DESCENDING THORACIC COMPONENT. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE FIRST VALIANT CAPTIVIA STENT GRAFT (VAMF3232C200TU SERIAL # (B)(6) WAS PLACED WITH MINIMAL RESISTANCE AND DEPLOYED SUCCESSFULLY. HOWEVER THE SECOND VALIANT CAPTIVIA STENT GRAFT (VAMC3636C150TU, SERIAL# (B)(6) WENT TO THE MID EXTERNAL ILIAC AND HAD RESISTANCE. WHEN THE PHYSICIAN PUSHED THE DEVICE THE ARTERY CLAMPED DOWN ON THE DELIVERY SYSTEM AND THE NOSE CONE AND THE OUTER GRAFT COVER GAP WAS LONGER ON THE FLUOROSCOPY IMAGE. THE PHYSICIAN ATTEMPTED TO PULL THE DEVICE BACK AND ENCOUNTERED INCREASED RESISTANCE AND CONTINUED TO TRY TO REMOVE THE DEVICE BUT WITH NO SUCCESS. THE PATIENT'S BLOOD PRESSURE STARTED FALLING AND THE PHYSICIAN IMMEDIATELY PLACED A RELIANT BALLOON AND CARRIED OUT A RETROPERITONEAL INCISION TO REPAIR THE LEFT EXTERNAL ILIAC ARTERY. THE PHYSICIAN IDENTIFIED THAT THE ARTERY WAS STUCK IN THE GAP BETWEEN THE NOSE CONE AND THE DELIVERY S YSTEM AND LOOKED LIKE IT INSIDE OUT STUCK IN THE GRAF

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Perforation of Vessels

  MAUDE report 19556654 ↗
• MalfunctionNov 3, 2020Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 50MM FUSIFORM THORACIC AORTIC ANEURYSM. THE AORTA WAS NOTED AS SEVERELY TORTUOUS. IT WAS REPORTED APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE A DISTAL TYPE IB ENDOLEAK WAS IDENTIFIED. PER THE INVESTIGATOR THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10777154 ↗