VALIANT® Captivia VAMC3834C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169346727), received between Feb 16, 2018 and Jun 22, 2023 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Leak/Splash” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED APRROXIMATELY 1 YEAR POST THE INDEX PROCEDURE THE PATIENT PHONED TECHNICAL SERVICES AND REPORTED THAT THEY STARTED HAVING PAIN IN THE UPPER LEFT CHEST AND REAR SHOULDER BLADE POST IMPLANT. IT WAS NOTED THAT THE PATIENT HAD SHINGLES AT THE TIME OF IMPLANT. THE PATIENT STATED THAT THE PHYSICIAN INFORMED THEM THAT THE PAIN EXPERIENCED WAS NORMAL. THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Chest Pain; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17181898 ↗
• DeathNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 200MM THORACIC AORTIC DISSECTION . THE DIAMETER OF THE PROXIMAL THORACIC AORTA WAS 36MM. IT WAS REPORTED THAT 3 DAYS LATER THE PATIENT EXPIRED. THE CAUSE OF THE POST IMPLANT DISSECTION CANNOT BE DETERMINED.  AS PER THE PHYSICIAN THE CAUSE OF DEATH WAS DUE TO RETROGRADE DISSECTION POST IMPLANT. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Vascular Dissection

  MAUDE report 12842841 ↗
• InjuryMar 23, 2018Leak/Splash; Leak/Splash

  A VALIANT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR AN UNKNOWN THORACIC ENDOVASCULAR TREATMENT. IT WAS REPORTED THAT THE PATIENT HAD A TYPE IB ENDOLEAK. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO GROWTH OF THE ANEURYSM SAC. THE EVENT WAS TREATED BY IMPLANTING AN ADDITIONAL ENDOGRAFT ALONG WITH 6 HELI-FX ENDOANCHORS. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7365496 ↗
• InjuryFeb 20, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM DIAMETER THORACIC AORTIC ANEURYSM AND IMH. IT WAS REPORTED THAT THE PATIENT RETURNED FOR A FOLLOW UP ON AN UNKNOWN DATE WHEN A TYPE IB ENDOLEAK WAS OBSERVED, WITHOUT ANEURYSMAL SAC EXPANSION. THE PHYSICIAN TREATED THE EVENT WITH THE IMPLANTATION OF A 40X100MM VALIANT STENT GRAFT DISTAL TO THE ORIGINAL VALIANT. IT IS NOTED THAT THIS HAS RESOLVED THE EVENT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED, DUE TO PROPAGATION OF THE IMH DISEASE DISTAL TO THE ORIGINAL STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN.

  Patient problems: Injury

  MAUDE report 7281603 ↗
• InjuryFeb 16, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 72MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE GRAFT WAS ORIGINALLY PLACED AT THE LEFT COMMON CAROTID ARTERY. IT WAS NOTED THAT THE PATIENT HAD A FOLLOW UP CT AND A TYPE IA ENDOLEAK WAS OBSERVED. AS PER THE PHYSICIAN, THE CAUSE OF THE ENDOLEAK WAS DUE TO DIFFICULT PATIENT ANATOMY. INTERVENTION WAS PERFORMED ON AN UNKNOWN DATE IN WHICH A SNORKEL PROCEDURE WAS PERFORMED, AND ANOTHER MANUFACTURERS DEVICE WAS USED TO TRY AND GAIN SEAL IN THE ASCENDING ARCH. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: Injury

  MAUDE report 7276047 ↗