VALIANT® Captivia VAMC4040C100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169347151), received between Dec 14, 2021 and Oct 29, 2024 — classified as 1 death, 2 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2024Leak/Splash; Leak/Splash

  TWO VALIANT CAPTIVIA STENT GRAFTS AND ONE VALIANT NAVION STENT GRAFT WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM. SEVEN MONTHS LATER, A SECONDARY PROCEDURE WAS PERFORMED TO TREAT A TYPE IA ENDOLEAK. IT WAS REPORTED APPROXIMATELY 5 YEARS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE PHYSICIAN¿S OFFICE AND, ALTHOUGH FEELING WELL, A CT SCAN REVEALED AN INCREASE IN THE THORACOABDOMINAL AORTIC ANEURYSM (TAAA), ALONG WITH A TYPE IB ENDOLEAK AND DISEASE PROGRESSION. INTERVENTION WAS PERFORMED 21 DAYS POST FOLLOW UP, AN ADDITIONAL VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED TO RESOLVE THE TYPE IB ENDOLEAK AND TAAA PROGRESSION. THE SITE ASSESSED THE TAA PROGRESSION AND ENDOLEAK AS RELATED TO THE UNDERLYING DISEASE AND NOT RELATED TO THE STUDY DEVICE OR INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 20555229 ↗
• DeathJul 18, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM AND FOUR VALIANT NAVION (B)(6) STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A ANEURYSM ON (B)(6) 2019. A VALIANT (B)(6) STENT GRAFT WAS ALSO IMPLANTED 3 MONTHS LATER AND ANOTHER VALIANT GRAFT (B)(6) SUBSEQUENTLY IMPLANTED APPROXIMATELY 8 MONTHS POST THE INDEX PROCEDURE. IT WAS REPORTED APPROXIMATELY 9 MONTHS POST THE INDEX PROCEDURE FOLLOW UP CT IDENTIFIED A TYPE IIIA ENDOLEAK WAS NOTED AT THE ABDOMINAL AORTIC STENT WHICH EXTENDS SUPERIORLY INTO THE DISTAL THORACIC AORTA. 9.5X7.8CM. CT AT 12 MONTHS SHOWED THERE WAS A PATENT ENDOVASCULAR STENT WHICH EXTENDS FROM THE DISTAL AORTIC ARCH INTO THE INFRARENAL ABDOMINAL AORTA, THERE IS A PERSISTENT LARGE TYPE III EL OF THE ABDOMINAL AORTIC STENT WHICH EXTENDS SUPERIORLY INTO THE DISTAL THORACIC AORTA, STABLE IN SIZE COMPARED TO PREVIOUS IMAGES. 8.4X7.0CM. INTERVENTION WAS THEN PERFORMED WHERE EMBOLIZATION WITH COILING WAS PERFORMED. A CT POST INTERVENTION APPROXIMATELY 16 MONTHS POST THE INDEX PROCEDURE SHOWED A NEW TYPE I ENDOLEAK ORIGINATING AT THE LEVEL OF THE PROXIMAL THORACIC ENDOGRAFT. THE PREVIOUS TYPE III ENDOLEAK WENT FROM 8.5CM TO 9.6CM. EMBOLIZATION WAS PERFORMED AGAI

  Patient problems: Cardiac Arrest

  MAUDE report 17340462 ↗
• InjuryDec 14, 2021Migration or Expulsion of Device; Material Deformation; Migration or Expulsion of Device; Material Deformation

  AN ENDURANT II STENT GRAFT SYSTEM AND A VALIANT CAPTIVIA STENT GRAFT WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED APPROXIMATELY 6 YEARS POST THE INDEX PROCEDURE VIA TECHNICAL SERVICES THAT THE PATIENT STATED THAT THE STENT GRAFT COLLAPSED AND THE PATIENT UNDERWENT A SURGERY TO HAVE AN AORTIC REPLACEMENT. NO CAUSE OF THE EVENT WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 13001494 ↗