VALIANT® Captivia VAMF3430C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169400146), received between Mar 21, 2017 and Jul 10, 2025 — classified as 2 deaths, 3 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 18, 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.

• MalfunctionJul 10, 2025Leak/Splash; Leak/Splash

  THREE VALIANT CAPTIVIA STENT GRAFTS (VAMF3430C150TU, VAMF3632C150TU AND VAMF3030C100TU) WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A TAA. A FOLLOW-UP CT SCAN PERFORMED APPROX. 10 YEARS POST INDEX PROCEDURE , REVEALED POST-SURGICAL CHANGES OF TEVAR. AN OUTPOUCHING FROM THE ENDOGRAFT WAS OBSERVED WITHIN THE ANEURYSM SAC, MEASURING UP TO 80MM IN DIAMETER¿AN INCREASE FROM A PREVIOUSLY MEASURED 40MM IN RETROSPECT. THIS FINDING WAS CONCERNING FOR A SUSPECTED PSEUDOANEURYSM / TYPE III ENDOLEAK, AND A TYPE IIIB ENDOLEAK WAS SUBSEQUENTLY CONFIRMED DUE TO DAMAGE OF THE GRAFT FABRIC. ADDITIONAL FINDINGS INCLUDED STABLE DILATION OF THE AORTIC SINUS (48 X 46 X 48 MM), STABLE DILATION OF THE DESCENDING AORTA UP TO 64MM, STABLE CHRONIC DISSECTION OF THE BRACHIOCEPHALIC ARTERY EXTENDING TO THE ORIGIN OF THE RIGHT SUBCLAVIAN AND COMMON CAROTID ARTERIES. THERE WAS ALSO INTERVAL REMODELING OF CHRONIC EMBOLI IN THE LEFT LOWER LOBE WITHOUT EVIDENCE OF INCREASED CLOT BURDEN. A STABLE DISSECTION AND ANEURYSMAL DILATION OF THE INFRARENAL ABDOMINAL AORTA (UP TO 34 MM) WAS NOTED, ALONG WITH AN UNCHANGED CHRONIC OCCLUSION OF THE RIGHT AXILLARY TO BILATERAL FEMORAL BYPASS GRAFT. THE STABLE CHRONIC DI

  Patient problems: Pseudoaneurysm

  MAUDE report 22466690 ↗
• InjuryJul 8, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE TO TREAT A DISSECTION, THE STENT GRAFT VAMF3430C150TU VALCAP TAPER WAS DIFFICULT TO DEPLOY DURING NOSE CONE EXTENSION, WITH TORQUE BUILD-UP AND STIFFNESS NOTED IN THE DEPLOYMENT SYSTEM WHEN DEPLOYING THE FREEFLO STENTS. IT WAS CONFIRMED THAT THE DEPLOYMENT STEPS WERE FOLLOWED PER THE INSTRUCTIONS FOR USE. THE SURGEON STATED THAT THE TIP CAPTURE RELEASE HANDLE WAS ¿STICKY¿/TOUGH TO ROTATE. RESISTANCE WAS FELT DURING THE DEPLOYMENT PROCESS. AFTER TORQUING ON THE HANDLE/DIAL IT EVENTUALLY ¿POPPED¿ OPEN DURING DEPLOYMENT. IT DID NOT DEPLOY SLOWLY AND NOT EASILY AS IT WOULD LIKELY DO SO IF THE GRAFT WAS STRAIGHT, OR STRAIGHTER THAT IT WAS IN THIS CASE. THE COVERED STENTS DEPLOYED NORMALLY WITHOUT ISSUE. THE PHYSICIAN NOTED THAT IT FELT LIKE A MECHANICAL PROBLEM WITH THE RELEASE MECHANISM OR PERHAPS SOME OF THE STRUTS WERE OVERLAPPING EACH OTHER IN THE BARE METAL SECTION AND WERE THEREFORE WEDGED INTO THE NOSE CONE. THERE WAS SOME EXTRA MANIPULATION REQUIRED IN ORDER TO RELEASE THE NOSE CONE. IMAGING CONDUCTED AFTER DEPLOYMENT SHOWED NO ISSUES WITH PLACEMENT. IT IS NOT BELIEVED THE PATIENT'S ANATOMY CONTRIBUTED TO THE DEPLOYMENT DIFFICULTY,

  Patient problems: Vascular Dissection

  MAUDE report 22433943 ↗
• InjuryOct 6, 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 TREATMENT OF A THORACIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE, A VALIANT NAVION STENT GRAFT AND AN ENDURANT STENT GRAFT SYSTEM WERE IMPLANTED TO TREAT AN EXTENSIVE TYPE II THORACOABDOMINAL ANEURYSM EXTENDING FROM ZONE 3-9 WITH PRIOR REPAIR OF THE ARCH FROM ZONE 1, 2 AND 3 WITH CAROTID TO CAROTID SUBCLAVIAN BYPASS. ENDO DEBRANCHING OF EXTENSIVE ANEURYSM USING A UNITARY GRAFT WAS PERFORMED BECAUSE OF THE SIZE OF THE SUPRACELIACAORTA FROM PREVIOUS STENTING SECONDARY TO DISSECTION AND ANEURYSMAL CHANGES. NO CAUSE WAS PROVIDED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Aneurysm; Vascular Dissection

  MAUDE report 17884819 ↗
• DeathMay 30, 2022Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. A VALIANT NAVION GRAFT WAS IMPLANTED 3 MONTHS LATER DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. A VALIANT CAPTIVIA WAS IMPLANTED 16 MONTHS LATER. THREE VALIANT NAVIONS WERE IMPLANTED AS PART OF A REINTERVENTION FOR PRIOR AORTIC REPAIR APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE FOLLOW UP CT WAS COMPLETED AFTER THE PATIENT BECAME UNWELL. A TYPE II ENDOLEAK AND MULTIPLE UNKNOWN ENDOLEAKS WERE OBSERVED. NEW ANEURYSMAL DEGENERATION OF THE TEVAR AT THE PROXIMAL PART WAS NOTED WHICH RESULTED IN AN ENDOLEAK REQUIRING PROXIMAL EXTENSION. DIFFERENTIAL DIAGNOSIS INCLUDED AORTIC RUPTURE VS. EMBOLIC INFARCT TO THE SPLEEN. IT WAS REPORTED THE PATIENT EXPIRED THE DAY AFTER THE CT. AS PER THE PHYSICIAN THE CAUSE OF DEATH WAS DUE TO MULTIPLE CAUSES - INFARCTION, INFECTION AND AORTIC RUPTURE. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Embolism/Embolus; Insufficient Information; Rupture; Unspecified Infection

  MAUDE report 14539945 ↗
• DeathMay 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A TYPE B DISSECTION EXTENDED FROM THE LEFT SUBCLAVIAN ARTERY DISTALLY TO THE ILIAC ARTERY. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A TYPE B DISSECTION THAT WAS CREATING MALPERFUSION TO THE RENAL ARTERIES, VISCERAL ARTERIES, AND LOWER EXTREMITIES. UPON ARRIVAL TO THE EMERGENCY ROOM THE PATIENT CODED. THE FINAL ANGIOGRAM REVEALED THAT THE VALIANT STENT GRAFT WAS SUCCESSFULLY IMPLANTED. WHEN THE PATIENT WAS BEING MOVED FROM THE OPERATING TABLE TO BED THE PATIENT CODED AGAIN AND EXPIRED. THE PHYSICIAN STATED THAT THE CAUSE OF THE DEATH WAS RELATED TO THE PATIENT¿S MALPERFUSION OF ALL THE RENAL ARTERIES AND VISCERAL ARTERIES. IT WAS NOTED THAT, POST IMPLANT, THE ANATOMY LOOKED GREAT AND THERE WAS BLOOD FLOW TO THE RENAL AND VISCERAL ARTERIES. THE PHYSICIAN STATED THAT THE STENT GRAFT WAS NOT THE CAUSE, THAT THE PATIENT HAD SYMPTOMS FOR A WEEK, AND THAT HE BELIEVED THE MALPERFUSION OVER AN EXTENDED TIME WAS PROBABLY THE CAUSE OF THE EVENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Multiple Organ Dysfunction Syndrome; Myocardial Infarction

  MAUDE report 6553108 ↗
• InjuryMar 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF 300 MM IN LENGTH THORACIC DISSECTION. IT WAS REPORTED THAT THE PATIENT HAD POST-OPERATIVE ISSUES. IT WAS REPORTED THAT FOUR DAYS POST INDEX PROCEDURE THE PATIENT HAD CODED AND WAS RESUSCITATED AND HAS BEEN HAVING HEART PROBLEMS, MAINTAINING THEIR HEART RATE AND CARDIAC OUTPUT. TWO OR THREE DAYS LATER THE PATIENT HAD PARALYSIS IN THEIR LEGS AND FEET. THE PHYSICIAN BELIEVES THAT WHEN THE PATIENT¿S HEART WAS UNSTABLE, THE CARDIAC OUTPUT DROPPED, WHICH INFARCTED THE SPINAL CORD, RESULTING IN THE PARALYSIS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: Ischemia; Myocardial Infarction; Paralysis

  MAUDE report 6421639 ↗