VALIANT® Captivia VAMF3026C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169400122), received between Mar 31, 2023 and Feb 4, 2025 — classified as 1 death, 1 injury.

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

• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED TO THE EMERGENCY ROOM APPROXIMATELY 1 YEARS AN 7 MONTHS POST-INDEX PROCEDURE WITH CHEST PAIN AND WAS FOUND DOWN AFTER A SEIZURE. A CT SCAN REVEALED A TYPE A DISSECTION. THE PATIENT HAD STOPPED TAKING ALL BLOOD PRESSURE MEDI CATIONS, WHICH WAS IDENTIFIED AS A CONTRIBUTING FACTOR TO THE DISSECTION. AN OPEN ASCENDING AORTIC ARCH REPAIR WAS PERFORMED, AND UPON EXAMINATION, A MID-ASCENDING TYPE A DISSECTION WAS DETERMINED. THE PHYSICIAN NOTED THAT THE VALIANT CAPTIVIA LOOKED WELL OPPOSED TO THE AORTA WITH NO FENESTRATIONS. A SURGICAL GRAFT WAS SEWN IN THE AORTIC ROOT AND OVER SEWN AROUND THE ENDOGRAFT WITH PLEDGETS.POST-OPERATION, THE PATIENT WAS EXTUBATED, ALERT, AND FOLLOWING COMMANDS. THE EVENT WAS RESOLVED WITH THE OPEN SURGERY, AND THE PATIENT IS STILL RECOVERING.

  Patient problems: Chest Pain; Convulsion/Seizure; Vascular Dissection

  MAUDE report 21302913 ↗
• DeathMar 31, 2023Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE EMERGENT ENDOVASCULAR TREATMENT OF A RUPTURED 56MM TAA. IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT GRAFT VAMF2026C150 CAME BACK UNEXPECTEDLY WHILE DEPLOYING AND IT DIDN'T LAND IN ITS INTENDED LOCATION. THREE OTHER VALIANT CAPTIVIA'S WERE ALSO IMPLANTED DURING THE PROCEDURE. THE PATIENT THEN EXPIRED AND DIDN'T SURVIVE THE PROCEDURE. THE CAUSE OF THE INACCURATELY DELIVERY OF THE STENT GRAFT IS UNKNOWN. THE PATIENT DIED DUE TO THE RUPTURED TAA. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Ruptured Aneurysm

  MAUDE report 16655464 ↗