VALIANT® Captivia VAMF3636C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169346963), received between Feb 2, 2017 and Dec 2, 2025 — classified as 5 deaths, 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• DeathDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS SYMPTOMATIC FOR MULTIPLE PENETRATING AORTIC ULCERS AND WAS IMPLANTED WITH MULTIPLE ENDOGRAFTS, INCLUDING THREE VALIANT CAPTIVIA STENT GRAFTS ( VAMF3636C200TU, TWO VAMF3636C150TU) AND AN ENDURANT AUI STENT GRAFT SYSTEM (ETUF3614C102E, ETLW1613C146E). THE PHYSICIAN CONCLUDED THE PROCEDURE WITH A FEM-FEM BYPASS WHICH WAS NOT PLANNED PRE-OPERATIVELY. IT WAS SAID THAT THE FEM-FEM BYPASS WAS PERFORMED BECAUSE THERE WAS EXCESSIVE OVER SIZING WITH THE VAMF3636C200TU STENT GRAFT DIAMETER. THE STENT GRAFT INFOLDED AND RIGHT ILIAC VESSEL OCCLUSION OCCURRED. THE OCCLUSION WAS DESCRIBED AS NOT THROMBUS-RELATED. THE PATIENT DIED POST OPERATIVELY, BUT THE CAUSE OF DEATH AND DATE OF DEATH ARE UNKNOWN. THE PATIENT'S CONDITION IN THE IMMEDIATE POST-OPERATIVE IS UNKNOWN. THE PATIENT DEATH WAS ASSESSED BY THE PHYSICIAN AS RELATED TO THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23690807 ↗
• InjuryJun 26, 2025Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A TAA. IT WAS NOTED THAT THE PATIENT HAD A HEMOTHORAX AND A MYCOTIC ANEURYSM. THE IMPLANTATION PROCEEDED WITHOUT ISSUE, AND THE PROSTHESIS WAS BALLOONED ALONG ITS ENTIRE LENGTH. FOLLOWING THE PROCEDURE, THE PATIENT WAS INITIALLY STABLE WITH NO LEAKAGE OBSERVED. THE PATIENT SUBSEQUENTLY REPORTED PAIN, PROMPTING A REPEAT COMPUTED TOMOGRAPHY SCAN PERFORMED THREE DAYS LATER, WHICH REVEALED A TYPE III ENDOLEAK. ANOTHER PROSTHESIS WAS PLACED WHICH RESOLVED THE ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK COULD NOT BE DETERMINED.

  Patient problems: Pain

  MAUDE report 22335607 ↗
• DeathJan 29, 2025Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE . THE PATIENT HAD AN EXISTING VALIANT CAPTIVA AND ENDURANT IIS STENT GRAFT SYSTEM IMPLANTED SIX MONTHS EARLIER. IT WAS REPORTED THAT CORELAB REVIEW OF A CT TAKEN ON THE SAME DATE SHOWED A IA AND IIIA ENDOLEAKS INVOLVING THE VALIANT NAVION. THERE WAS NO FRACTURE, STENT RING ENLARGEMENT OR STENT RING MIGRATION OBSERVED. THE MAXIMUM AORTIC DIAMETER WAS 96.8MM. IT WAS NOTED THAT THE VALIANT NAVION WAS FAILING TO SEAL WITH THE OTHER DEVICES. THE SITE COULD NOT CONFIRM WHICH DEVICE THE NAVION HAS LOST SEAL AGAINST. IT IS UNKNOWN IF THERE WERE INTERVENTIONS PERFORMED TO TREAT THE ENDOLEAKS. NO CAUSE WAS PROVIDED. IT WAS REPORTED THE PATIENT EXPIRED THE SAME YEAR. NO CAUSE OF DEATH WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED

  Patient problems: Insufficient Information

  MAUDE report 21263076 ↗
• MalfunctionOct 1, 2024Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT (VNMC3731C207TU) WAS IMPLANTED DURING REINTERVENTION OF A PRIOR AORTIC REPAIR. THE PATIENT HAD A VALIANT CAPTIVIA SENT GRAFT (VAMF3636C150TU) IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A TYPE B THORACIC DISSECTING ANEURYSM ALONG WITH EMBOLIZATION OF THE LEFT SUBCLAVIAN ARTERY USING A VASCULAR PLUG APPROXIMATELY 5 YEARS PREVIOUS. IT WAS REPORTED THAT CORELAB REVIEW OF CT APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE SHOWED NEW STENT RING ENLARGEMENT OF +3.6MM ON RING 4 OF (B)(6). THERE WAS NO ENDOLEAK, NO FRACTURE, NO AORTIC ENLARGEMENT AND NO STENT RING MIGRATION OBSERVED. THE MAXIMUM AORTIC DIAMETER WAS NOTED AS 64.1MM. THE HOSPITAL ANALYSIS OF THE CT SHOWED AORTIC ENLARGEMENT WITH THE VALIANT NAVION STENT GRAFT. THE PATIENT HAD BOTH THE VALIANT CAPTIVIA STENT GRAFT AND A VASCULAR PLUG IMPLANTED PROXIMALLY. THE VALIANT NAVION STENT GRAFT WAS IMPLANTED DUE TO DISEASE PROGRESSION AND NOT A FAILURE OF THE VALIANT CAPTIVIA STENT GRAFT. PER THE SITE, CT IMAGING APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE IDENTIFIED AORTIC ENLARGEMENT. NO ENDOLEAK, STENT RING ENLARGEMENT , STENT RING MIGRATION WERE NOTED. NO SECONDARY PROCEDURE IS PLANNED IN RELATION

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20342973 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR REPAIR OF A TYPE B DISSECTION. LEFT SUBCLAVIAN ARTERY EMBOLIZATION WITH PLUGGING WAS ALSO PERFORMED WITH A VASCULAR PLUG IMPLANTED. IT WAS REPORTED THAT A VALIANT NAVION STENT GRAFT WAS IMPLANTED AS RE-INTERVENTION DUE TO THE PATIENTS PROGRESSION OF DISEASE, NOT FROM FAILURE OF THE GRAFT . PER THE PHYSICIAN THE CAUSE OF THE INTERVENTION WAS DISEASE PROGRESSION.   NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 17449165 ↗
• InjuryNov 17, 2021Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED ON AN UNKNOWN DATE A TYPE II ENDOLEAK WAS IDENTIFIED. APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE INTERVENTION WAS COMPLETED FOR A TYPE IA AND IB. 2 ADDITIONAL VALIANT NAVION STENT GRAFTS 37X37X182 MM AND 37X31X207 WERE IMPLANTED. APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE THE PATIENTS WIFE REPORTED THAT AN UNKNOWN ENDOLEAK WAS IDENTIFIED ON CT. PER THE PHYSICIAN THE CAUSE OF THE TYPE IA AND IB ENDOLEAKS WAS SUSPECTED TO BE DUE TO THE TYPE II ENDOLEAK. THE ENDOLEAK SEEN ON CT 4 YEARS POST THE INDEX PROCEDURE IS UNKNOWN AT THIS TIME AND NO FURTHER INTERVENTION HAS BEEN COMPLETED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12826359 ↗
• DeathAug 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT THORACIC STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR AN UNKNOWN ENDOVASCULAR PROCEDURE IT WAS REPORTED THE PATIENT EXPIRED ON THE SAME DATE NO CAUSE WAS PROVIDED.

  Patient problems: Cardiac Arrest; Insufficient Information

  MAUDE report 12352736 ↗
• InjuryJun 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED TO HOSPITAL WITH AN AORTO-TRACHEAL FISTULA THAT WAS AT THE LEVEL OF THE STENT GRAFT. A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE AORTIC ARCH TO COVER THE FISTULA AND A RIGHT CAROTID TO LEFT CAROTID TO SUBCLAVIAN BYPASS WAS CARRIED OUT PRIOR TO PLACEMENT OF THE GRAFT. THE PROXIMAL END OF THE GRAFT WAS PLACED AT THE LEVEL OF THE INNOMINATE AND DEPLOYED INTO THE EXISTING VALIANT CAPTIVIA GRAFT. THERE WAS STILL SLIGHT FILING OF THE FISTULA, BUT THE PHYSICIAN EXPECTS IT WILL CLOT OFF. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO THE PATIENT'S TISSUE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Fistula

  MAUDE report 8674972 ↗
• InjuryMay 21, 2019Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 2 YEARS 8 MONTHS POST INDEX PROCEDURE, A FOLLOW UP CT SHOWED A TYPE IA ENDOLEAK. PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 8627452 ↗
• DeathNov 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HELI-FX APPLIER AND ENDOANCHORS WERE USED PROPHYLACTICALLY AS AN ACCESSORY DEVICE FOR THE ENDOVASCULAR TREATMENT OF THE PATIENT WITH A VALIANT STENT GRAFT SYSTEM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN PLACED THE HELI- FX GUIDE IN THE APPROPRIATE LOCATION TO DEPLOY AN ENDOANCHOR IN THE RIGHT LATERAL WALL OF THE DESCENDING THORACIC AORTA, JUST ABOVE THE CELIAC. AFTER DEPLOYING THE ENDOANCHOR TO THE FIRST STAGE, IT WAS DETERMINED THAT IT WAS IN A GOOD POSITION. WHEN THE ENDOANCHOR WAS FULLY DEPLOYED, IT APPEARED TO "FLOAT" BEHIND THE EXISTING STENT GRAFT AND SETTLED IN THE DESCENDING ANEURYSM SAC BEHIND THE STENT GRAFT. A SECOND ENDOANCHOR WAS THEN PLACED BY THE PHYSICIAN IN A SIMILAR LOCATION AND IT ALSO APPEARED TO "FLOAT" THROUGH THE STENT GRAFT WALL TO A SIMILAR LOCATION. IT WAS NOTED THAT PLACEMENT OF THE ENDOANCHORS IN THE LEFT ASPECT OF THE STENT GRAFT WAS SUCCESSFUL. AS PER THE PHYSICIAN, THE CAUSE OF THE ENDOANCHOR EVENT WAS PRODUCT RELATED. IT WAS REPORTED THAT, 6 DAYS POST INDEX PROCEDURE, THE PATIENT HAD A CARDIAC EVENT DURING ROUTINE EXERCISE WITH THE REGISTERED NURSE AND DIED AFTER CPR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. IT WAS REPO

  Patient problems: Cardiac Arrest; Death

  MAUDE report 7056724 ↗
• DeathOct 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE TREATMENT OF A PENETRATING AORTIC ULCER NEAR THE LEFT SUBCLAVIAN ARTERY. PRIOR TO THE INDEX PROCEDURE THE PHYSICIAN PERFORMED A GREAT VESSEL DEBRANCHING BY PLACING A GRAFT OFF THE ASCENDING ARCH AND BYPASSING THE INNOMINATE ARTERY AND LEFT CAROTID ARTERY. THIS WAS ACHIEVED VIA A STERNOTOMY AND IMPLANTATION OF A NON-MEDTRONIC GRAFT. IT WAS REPORTED THAT THE PATIENT HAD A CARDIAC ARREST AND WAS RESUSCITATED. AN EMERGENCY CT PERFORMED SHOWED A RETROGRADE TYPE A DISSECTION THAT APPEARS TO HAVE ORIGINATED AT A PIECE OF PLAQUE ON THE LESSER CURVE. THE PATIENT WAS TAKEN TO OR IMMEDIATELY TO PERFORM AN ASCENDING REPAIR, HOWEVER THE PATIENT¿S CHEST WAS FULL OF BLOOD AND ARRESTED AGAIN AND EXPIRED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED AS NO AUTOPSY WAS PERFORMED THEREFORE UNABLE TO DETERMINE IF THE DISSECTION HAPPENED DUE TO THE GRAFT, SURGICAL PROCEDURE BEFORE IMPLANT OR ANYTHING OTHER CONDITION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Cardiac Arrest; Death; Vascular Dissection

  MAUDE report 6960664 ↗
• InjuryMay 25, 2017Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT THE PATIENT RETURNED FOR FOLLOW-UP AND THE CT SHOWED THE PATIENT DEVELOPED A PROXIMAL TYPE I ENDOLEAK. THE PATIENT HAS THREE STENT GRAFTS IMPLANTED FROM THE ORIGINAL PROCEDURE. THE VALIANT STENT GRAFT IS DISTAL AND TWO STENT GRAFTS ARE PROXIMAL; HOWEVER, IT IS UNKNOWN WHICH DEVICE WAS THE PROXIMAL MOST WHERE THE ENDOLEAK IS COMING FROM. THE ENDOLEAK WAS ON THE INNER CURVE OF THE ARCH. THE PHYSICIAN IMPLANTED 12 ENDOANCHORS AT THE PROXIMAL END OF THE STENT GRAFT TO TRY TO RESOLVE THE ENDOLEAK. THE ORIGINAL STENT GRAFT WAS AT THE LEVEL OF THE SUBCLAVIAN ARTERY AND THE PATIENT HAS A DIALYSIS GRAFT IN THE LEFT ARM SO A PROXIMAL EXTENSION WAS NOT AN OPTION AT THIS TIME. THE PROCEDURE WENT WELL WITH THE ENDOLEAK FILLING VERY LATE. ALTHOUGH, IT WAS NOTED THAT THE LEAK HAD APPEARED TO RESOLVE. THE PHYSICIAN DECIDED TO STOP AND NOT PERFORM ANY FURTHER INTERVENTION. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS ANATOMY RELATED (PROXIMAL NECK DEGENERATIVE DISEASE SINCE PATIENT WAS TREATED FOR DISSECTION ON ORIGINAL PROCEDURE). NO ADDITION

  Patient problems: Injury

  MAUDE report 6592728 ↗
• InjuryFeb 2, 2017Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 4.7 CM IN DIAMETER THORACIC AORTA ANEURYSM. IT WAS REPORTED THAT THE PATIENT RETURNED FOR FOLLOW UP. THE CT REVEALED THAT HERE WAS A DISTAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO THORACIC AORTIC STENT GRAFT EXTENSIONS AND THE ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO LOSS OF APPOSITION TO THE AORTIC WALL THAT MAY HAVE BEEN DUE TO AORTIC DILATATION AT THAT LOCATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6298934 ↗