VALIANT® Captivia VAMF3838C100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169347045), received between May 8, 2018 and Jul 23, 2025 — classified as 1 death, 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2025Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT (VAMF3838C100TU, SN (B)(6))WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY 2 YEARS AND 1 MONTH POST-INDEX PROCEDURE, A TYPE IA ENDOLEAK WAS IDENTIFIED. APPROXIMATELY ONE MONTH LATER, , AN INTERVENTION WAS PERFORMED TO TREAT THE ENDOLEAK. IT WAS REPORTED THAT DURING THE PROCEDURE, WHICH INVOLVED A VALIANT CAPTIVIA STENT GRAFT OF THE SAME MODEL (SN (B)(6)), RESISTANCE WAS FELT DURING INSERTION OF THE DELIVERY SYSTEM INTO THE PATIENT. THE PHYSICIAN REPORTED DIFFICULTY ADVANCING THE DELIVERY SYSTEM INTO THE VESSEL AND DID NOT FEEL COMFORTABLE APPLYING ADDITIONAL FORCE. UPON INSPECTION, A GAP WAS OBSERVED IN THE DELIVERY SYSTEM BETWEEN THE NOSE CONE AND THE GRAFT COVER. NO DAMAGE TO THE DEVICE OR THE DEVICE'S PACKAGING WAS NOTED PRIOR TO USE. A NEW VALIANT CAPTIVIA STENT GRAFT OF THE SAME MODEL (SN (B)(6)) WAS USED AS A REPLACEMENT AND WAS SUCCESSFULLY IMPLANTED, RESOLVING THE TYPE IA ENDOLEAK. PER THE PHYSICIAN, THE CAUSE OF THE POSITIONING DIFFICULTY/GAP WAS ATTRIBUTED TO A DEFECTIVE DEVICE AND THERE WAS NO VESSEL CALCIFICATION, THROMBUS OR TORTUOSITY THAT MAY HAVE CONTRIBUTED TO THE THIS EVENT. NO CAUSE FOR THE ENDOLEA

  Patient problems: Insufficient Information

  MAUDE report 22575526 ↗
• InjuryJan 15, 2024Positioning Problem; Positioning Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A TAA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE GRAFT WAS UNABLE TO BE DELIVERED DUE TO ANATOMY. DURING AN ATTEMPT THE ILIAC WAS PERFORATED. INTERVENTION WAS PERFORMED AND STENT GRAFTS WERE PLACED ACROSS THE PERFORATED ILIAC. IT WAS REPORTED THE PATIENT SUFFERED A CVA POST THE INDEX PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE PERFORATION WAS DUE TO THE PATIENT'S ANATOMY. IT WAS NOTED THAT THE VESSEL WAS CALCIFIED AND TORTUOUS. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Perforation of Vessels; Stroke/CVA

  MAUDE report 18510390 ↗
• MalfunctionApr 25, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. IT WAS REPORTED THAT A FOLLOW-UP CT TAKEN 2 YEARS AND 9 MONTHS POST INDEX PROCEDURE SHOWED AN UNKNOWN ENDOLEAK. THE VALIANT NAVION STENT GRAFTS WERE RELINED ON THE SAME DATE WITH A VALIANT CAPTIVIA S/N: (B)(4) , BUT THE ENDOLEAK REMAINED. PER THE PHYSICIAN, THE CAUSE OF THE ENDOLEAK IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16805145 ↗
• DeathApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED UNDER FOUR YEARS LATER THE PATIENT PRESENTED EMERGENTLY. A TYPE IA ENDOLEAK AND RUPTURED 100MM INFRARENAL ABDOMINAL ANEURYSM WAS DIAGNOSED. IT WAS NOTED A PRE-EXISTING CUFF OF UNKNOWN VENDOR WAS ALSO PRESENT. INTERVENTION WAS COMPLETED WHERE THE PHYSICIAN EXPLANTED THE EXISTING BIFURCATE AND SURGICAL GRAFTS WERE SEWN IN. A 38X38X100 VALIANT CAPTIVIA STENT GRAFT WAS ALSO IMPLANTED IN THE DESCENDING THORACIC AORTA. IT WAS REPORTED THE PATIENT EXPIRED DURING THE PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE RUPTURE, TYPE IA ENDOLEAK AND DEATH ARE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 16662244 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN UNKNOWN HEART VALVE WAS INTENDED TO BE IMPLANTED IN A TAVR PROCEDURE. FOLLOWING THE FAILED TAVR ATTEMPT, THE PHYSICIAN  IMPLANTED A VALIANT CAPTIVIA TO TREAT A TAA.  IT WAS REPORTED THROUGH THE PATIENT DIRECTLY THAT THEY EXPERIENCED A HEMATOMA AT THE ACCESS SITE (GROIN) FOR A FEW DAYS FOLLOWING THE PROCEDURE. THEY WERE EXAMINED BY THEIR HCPS AND IT WAS DIAGNOSED AS A HEMATOMA AND NOT A HERNIA. THE PATIENT REPORTED HAVING BLEEDING FOR A TIME FOLLOWING THE PROCEDURE. THERE WAS ALSO AN ANGIOSEAL CLOSURE DEVICE USED AT THE ACCESS SITE. NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16581421 ↗
• InjuryMay 8, 2018Difficult To Position; Difficult To Position

  A VALIANT STENT GRAFT SYSTEM WAS PLANNED FOR IMPLANTATION IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50 MM DIAMETER A PENETRATING DESCENDING AORTIC ANEURYSM. AN ENDURANT STENT GRAFT SYSTEM WAS ALSO USED FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PATIENTS ACCESS VESSELS RANGED IN DIAMETER BETWEEN 6.2-7.2 MM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE VALIANT DEVICE WAS ATTEMPTED TO BE DELIVERED BUT WAS UNABLE TO PASS DUE TO THE NARROW AND CALCIFIED ACCESS VESSELS. THE VALIANT WAS TRIED BARE-BACK WITH NO SUCCESS. 18 AND 20F DILATORS WERE THEN USED TO ATTEMPT DELIVERY OF DEVICE AGAIN VIA AN AORTIC BIFURCATE BUT THIS WAS UNSUCCESSFUL. ANGIOGRAPHY THEN SHOWED PERFORATION OF THE EXTERNAL ILIAC AND DISTAL COMMON FEMORAL ARTERIES. THIS PERFORATION REQUIRED SURGICAL BYPASS REPAIR AND ADDITIONALLY THE ANEURYSM WAS SUCCESSFULLY TREATED. THE PAU REMAINS UNTREATED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO THE NARROW AND CALCIFIED ACCESS VESSELS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Perforation of Vessels

  MAUDE report 7494084 ↗