VALIANT® Captivia VAMF2626C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169347014), received between Apr 12, 2017 and May 23, 2022 — classified as 2 deaths, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION AND VALIANT CAPTIVIA STENT GRAFT WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT EXPIRED 37 DAYS AFTER THE INDEX PROCEDURE. IT WAS REPORTED THERE MAY HAVE BEEN AORTIC ENLARGEMENT NOTED WITH THE STENT IN PLACE. NO CAUSE OF DEATH HAS BEEN PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Aneurysm; Insufficient Information

  MAUDE report 14469298 ↗
• InjuryMar 22, 2021Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN AN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THE PATIENT WAS HAVING UNKNOWN SYMPTOMS. AN ANGIOGRAM WAS PERFORMED WHICH SHOWED NO EVIDENCE OF A LEAK AS PER THE PHYSICIAN, ALTHOUGH IT WAS STATED BY A RADIOLOGIST THERE WAS A POSSIBILITY OF A TYPE III ENDOLEAK PROXIMALLY. INTERVENTION WAS PERFORMED APPROXIMATELY 2 YEARS AND 9 MONTHS POST IMPLANT, AND AN ADDITIONAL VALIANT STENT GRAFT WAS IMPLANTED. ALTHOUGH THERE WAS NO LEAK FOUND, BUT THE PROXIMAL SEAL ZONE WAS VERY SHORT SO IT WAS DECIDED TO PLACE A GRAFT WITHIN THE EXISTING GRAFT EXTENDING THE EXISTING GRAFT BY APPROXIMATELY 20MM. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11548233 ↗
• MalfunctionAug 29, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  A VALIANT STENT GRAFT SYSTEM WAS PLANNED TO BE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 220MM LENGTH THORACIC DISSECTION. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AS THE DEVICE WAS REMOVED FROM THE PACKAGING IT WAS NOTED THAT THE REAR BLUE WHEEL OF THE DEVICE HAD DETACHED AND WAS SNAPPED IN TWO PIECES. NO DAMAGE WAS NOTED TO THE OUTER PACKAGING OF THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER VALIANT CAPTIVIA STENT GRAFT SYSTEM. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS PRODUCT RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7826020 ↗
• DeathApr 12, 2017Malposition of Device; Malposition of Device

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A RUPTURED THORACIC ULCER BLEEDING INTO THE AIRWAY . DURING THE INITIAL EMERGENT IMPLANTATION, THE VALIANT STENT GRAFT WAS UNBEKNOWNST AND INADVERTENTLY IMPLANTED COVERING BOTH SUBCLAVIAN ARTERIES. THERE WAS AN UNKNOWN ABERRANT RIGHT SUBCLAVIAN DISTAL TO THE LEFT SUBCLAVIAN ARTERY. AT THE TIME OF IMPLANT THE PATIENT WAS UNSTABLE AND COULD NOT TOLERATE A CAROTID TO SUBCLAVIAN BYPASS, BUT WOULD BE SCHEDULED FOR A LATER DATE. IT WAS REPORTED THAT THE UNBEKNOWNST COVERING OF BOTH SUBCLAVIAN ARTERIES RESULTED IN A CVA/STROKE AND THE PATIENT EXPIRED EIGHT DAYS LATER. PER THE PHYSICIAN, THE CAUSES OF THE EVENTS WERE RELATED TO THE PATIENT¿S ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death; Occlusion; Stroke/CVA

  MAUDE report 6488076 ↗