VALIANT® Captivia VAMC3030C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169346598), received between May 4, 2018 and Oct 4, 2022 — classified as 1 death, 1 malfunction.

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

• DeathOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED AS PART OF A 'BUFFALO TRUNK" TECHNIQUE IN THE REPAIR OF A 57MM TAA.  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PATIENT EXPERIENCED SIGNIFICANT BLOOD LOSS DUE TO AN UNKNOWN REASON. THE ARCH WAS TOTALLY REPAIRED AND SUTURED TO THE STENT GRAFT,  IMPLANTED INTO THE DESCENDING AORTA. THE SAC WAS STILL PRESSURIZED SO AN ARTERIOGRAM WAS PERFORMED WHICH  SHOWED NO LEAKS TO THE ARCH REPAIR OR STENT GRAFT.  THE VERTEBRAL ARTERY AND THE   LEFT INTERNAL MAMMARY ARTERY WERE STILL FEEDING THE SAC DUE TO LIGATION OF THE LEFT SUBCLAVIAN DISTAL TO LEFT VERTEBRAL ARTERY. THE PATIENT BECAME HEMODYNAMICALLY STABLE ON THE TABLE BEFORE THE SURGERY WAS COMPLETED. THE PATIENT THEN EXPIRED 2 DAYS LATER. IT WAS SAID THE CAUSE WAS THAT THE PATIENT DID NOT RESPOND WELL POST THE SURGERY. IT WAS CONFIRMED THE STENT GRAFT LOOKED GREAT AND THE PHYSICIAN HAD BEEN OPTIMISTIC OF A GOOD RESULT. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 15535101 ↗
• MalfunctionMay 4, 2018Break; Break

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS PLANNED TO BE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 250 MM THORACIC DISSECTION. IT WAS REPORTED THAT WHEN THE PRODUCT WAS OPENED IT THE SIDE PORT ON THE DEVICE WAS DETACHED FROM THE DELIVERY SYSTEM. THE PHYSICIAN REPORTED THAT THE DEVICE WAS BROKEN. IT WAS NOTED THAT THERE WAS NO DAMAGE TO THE STERILE PACKAGING OR BOX ON INSPECTION. A DIFFERENT VALIANT STENT GRAFT SYSTEM WAS USED AND THE EVENT WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7487506 ↗