VALIANT® Captivia VAMF2222C100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169347120), received between Nov 13, 2017 and May 2, 2025 — classified as 3 deaths, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 2, 2025Material Deformation; Positioning Problem; Material Deformation; 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 EXTRA

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

  MAUDE report 21949370 ↗
• DeathNov 2, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR AND AORTIC INTRAMURAL HEMATOMA (IMH). IT WAS REPORTED DURING THE INDEX PROCEDURE THE PATIENT HAD EMERGENT TOTAL ARCH REPLACEMENT . PHYSICIAN REQUESTED THAT THE REP BRING IN A 20X20 GRAFT  THE REP INFORMED THE PHYSICIAN THAT THERE WAS A 22X22. THE REP BROUGHT IN A 22X22, A24X24 AND A26X26 GRAFT TO THE CASE. AFTER GETTING A MEASUREMENT OF 24MM THE REP SUGGESTED A 24 OR 26. THE PHYSICIAN STATED A 22  WOULD BE USED BECAUSE THE IMPLANTED GRAFT WAS SMALL SO A 22MM VALIANT WAS DELIVERED TO THE FIELD. THE REP NOTED THERE WAS NO IMAGING OR IVUS ULTRA SOUND AVAILABLE AND THE PHYSICIAN STATED THERE WAS DIRECT VISUALISATION. THE GRAFT WAS DEPLOYED WITH OUT THE REPS VISUALISATION AND AFTER DEPLOYMENT BOTH PHYSICIANS STATED THAT THE GRAFT LOOKED GOOD.  IT WAS REPORTED DURING A CT ONE DAY POST INDEX PROCEDURE THAT THE GRAFT HAD MIGRATED TO THE DISTAL SEGMENT OF THE THORACIC AORTA. THE PATIENT WAS BROUGHT TO THE OR WHERE A THORACOTOMY WAS CARRIED OUT AND THE 22X22X100 GRAFT WAS EXPLANTED. IT WAS THEN REPORTED THE PATIENT EXPIRED TWO DAYS LATER. NO CAUSE HAS BEEN REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WAS P

  Patient problems: Insufficient Information

  MAUDE report 12735267 ↗
• MalfunctionJul 21, 2020Use of Device Problem; Use of Device Problem

  VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT. IT WAS REPORTED THROUGH TECHNICAL SERVICES, THAT ACCORDING TO THE EXPIRED PRODUCT REPORT, THE DEVICE IMPLANTED IN THE PATIENT WAS EXPIRED. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10301863 ↗
• DeathNov 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE EMERGENT TREATMENT OF AN ENDOVASCULAR TRANSECTION CAUSED BY BLUNT TRAUMA. HOWEVER, IT WAS REPORTED THAT THE PATIENT DIED APPROXIMATELY 96 HOURS POST IMPLANT OF THE STENT GRAFT. THERE WAS NO EVIDENCE OF STENT GRAFT FAILURE ON THE FOLLOW UP SCAN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death

  MAUDE report 7023922 ↗