VALIANT® Captivia VAMC3632C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169346864), received between Mar 21, 2017 and Mar 18, 2025 — classified as 1 death, 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (4 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.

• InjuryMar 18, 2025Leak/Splash; Leak/Splash

  TWO VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A TAA. IT WAS REPORTED APPROXIMATELY 14 MONTHS POST INDEX PROCEDURE THAT THE PATIENT WAS HOSPITALISED AND A IA ENDOLEAK WAS OBSERVED. INTERVENTION WAS PERFORMED VIA A PROXIMAL TEVAR EXTENSION WHERE A VALIANT CAPTIVIA WAS IMPLANTED ON THE SAME DATE. DURING THE PROCEDURE THE LSA WAS REVASCULARIZED. THE REINTERVENTION WAS SUCCESSFUL AND THE PATIENT WAS DISCHARGED HOME IN A STABLE CONDITION. THE SITE ASSESSED THE ENDOLEAK AS HAVING A CAUSAL RELATIONSHIP TO THE STUDY DEVICE AND PROBABLY RELATED TO THE STUDY PROCEDURE. NO CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 21629575 ↗
• InjuryNov 20, 2020Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 60 MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 44 MONTHS POST INDEX PROCEDURE, PATIENT WAS CONTINUING TO HAVE SYMPTOMS OF THORACIC ANEURYSM. CT WAS PERFORMED, WHERE AN UNKNOWN ENDOLEAK WAS NOTED. IT WAS STATED THAT THE PHYSICIAN DECIDED TO EXPLANT THE STENT GRAFT AND REPAIR ENDOLEAK VIA OPEN SURGICAL MEANS. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS ANATOMY. IT WAS STATED THAT THE STENT GRAFT WAS PLACED IN HIGHLY ANGULATED PROXIMAL ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE

  Patient problems: Unspecified Tissue Injury

  MAUDE report 10874745 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT MONA LSA STENT GRAFT SYSTEM AND A VALIANT CAPTIVIA STENT GRAFT WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THREE DAYS LATER THE PATIENT COMPLAINED OF AN ANTERIOR HEADACHE AND MEDICATIONS WERE GIVEN. THE PATIENT¿S SYMPTOMS IMPROVED AFTER THE LUMBAR DRAIN WAS REMOVED BUT FOUR DAYS POST THE INDEX PROCEDURE EXPERIENCED SUDDEN HEADACHE WITH NAUSEA AND VOMITING. THE EVENT RESOLVED WITH MEDICATION. THE INVESTIGATOR HAS ASSESSED THE EVENT TO NOT BE RELATED TO DEVICE OR PROCEDURE. THE SPONSOR HAS ASSESSED THE EVENT TO NOT BE RELATED TO THE DEVICE BUT RELATED TO THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Headache; Nausea; Vomiting

  MAUDE report 8863823 ↗
• InjuryJun 1, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED 80MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT ON CT FOUR DAYS LATER A TYPE III SEPARATION ENDOLEAK WAS OBSERVED BETWEEN THE PROXIMAL AND DISTAL STENT GRAFT. ANOTHER VALIANT STENT GRAFT WAS PLACED OVER THE JUNCTION TO RESOLVE THE ENDOLEAK ONE WEEK LATER. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO THE DISTAL STENT GRAFT LANDING ON EXTREMELY TORTUOUS ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7560315 ↗
• DeathJan 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 260MM LENGTH THORACIC AORTIC DISSECTION. APPROXIMATELY 2 DAYS PRIOR TO THE INDEX PROCEDURE, THE PATIENT HAD AN OPEN DEBRANCHING OF THE AORTIC ARCH AND DURING THE INDEX PROCEDURE THE STENT GRAFT SYSTEM WAS IMPLANTED IN THE THORACIC AORTA, FROM THE INNOMINATE ARTERY ORIGIN TO THE DISTAL THORACIC TO TREAT A DISSECTION WITH IMH. BOTH PROCEDURES WENT WELL. THE FOLLOWING DAY, THE PATIENT HAD SUDDEN ONSET CHEST PAIN AND WAS RUSHED TO CT. THE CT SHOWED A RETROGRADE DISSECTION. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS UNKNOWN. THE PATIENT DIED SHORTLY AFTER.

  Patient problems: Death; Pain; Vascular Dissection

  MAUDE report 7192849 ↗
• MalfunctionMar 21, 2017Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 300 MM THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT THE PATIENT HAD PRESENTED 3 TIMES TO THE ER WITH BACK AND ARM PAIN. A CT REVEALED THAT THE FALSE LUMEN WAS FILLING. BECAUSE THIS WAS THE THIRD TIME THE PATIENT PRESENTED, THEIR PHYSICIAN DECIDED TO EXTEND THE VALIANT DEVICE. A 36X32X150 DEVICE WAS IMPLANTED DOWN TO THE CELIAC ARTERY. DURING THE PROCEDURE, NO ANGIOGRAMS WERE PERFORMED. IT WAS NOTED THAT THE FALSE LUMEN WAS STILL VISUALIZED USING INTRAVASCULAR ULTRASOUND. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS AND THE EVENT RESOLVED. THE PATIENT COULD MOVE THEIR LEGS AND WAS REPORTEDLY RECOVERING WELL. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6422311 ↗