VALIANT® Captivia VAMF4440C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169400191), received between May 29, 2018 and Apr 19, 2024 — classified as 2 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 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.

• MalfunctionApr 19, 2024Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT (VNMF4640C185TU) AND A VALIANT CAPTIVIA STENT GRAFT (VAMF4440C150TU) WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM.THE PATIENT HAD 2 EXISTING VALIANT NAVION STENT GRAFTS AND A VALIANT CAPTIVIA STENT GRAFT IMPLANTED ONE YEAR PREVIOUS. THE PATIENT ALSO HAS NON MDT STENTS IMPLANTED. IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING TAKEN 3 YEARS POST THE NAVION IMPLANT SHOWED A NON-NAVION TYPE IB ENDOLEAK. THE IMAGING WAS NOTED AS DIFFICULT TO EVALUATE FOR FRACTURE DUETO MULTIPLE DEVICE OVERLAPS. THE MAX AORTIC DIAMETER WAS NOTED AS 80MM. THE IMAGING WAS NA FOR AORTIC ENLARGEMENT. NO ENDOLEAKS, STENT FRACTURE, STENT RING ENLARGEMENT OR STENT RING MIGRATION WERE OBSERVED. THE CAUSE OF THE TYPE IB ENDOLEAK IS UNDETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm expansion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142780 ↗
• InjuryOct 1, 2018Adverse 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 AN UNKNOWN ENDOVASCULAR TREATMENT. ON THE SAME DATE AS THE INDEX PROCEDURE, IT WAS REPORTED THAT THE PATIENT WAS FOUND SLUMPED IN A CHAIR AND TAKEN BACK TO HOSPITAL. A TYPE A RETROGRADE AORTIC DISSECTION 250MM IN LENGTH WAS OBSERVED. AORTIC REPAIR WAS CARRIED OUT OF THE ASCENDING AORTA. IT WAS REPORTED THAT THE EVENT WAS RESOLVED. AS 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: Intimal Dissection

  MAUDE report 7922625 ↗
• InjuryMay 29, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 52 MM THORACIC AORTIC ANEURYSM. APPROXIMATELY A YEAR AND A HALF LATE IT WAS REPORTED THAT ANEURYSM ENLARGEMENT AND A TYPE IA ENDOLEAK WERE IDENTIFIED ON A FOLLOW UP CT SCAN. THE ANEURYSM HAD GROWN FROM 52MM TO 93MM. IT WAS ALSO REPORTED THE PATIENT HAD A LARGE TYPE II ENDOLEAK FROM THE LEFT SUBCLAVIAN THAT WAS NOT EMBOLISED AT THE TIME OF THE IMPLANT. THE PHYSICIAN REPORTED THE CAUSE OF THE EVENT TO RELATED TO THE TYPE II ENDOLEAK WHICH CAUSED THE ANEURYSM TO GROW WHICH CAUSED THE TYPE I ENDOLEAK. AN INTERVENTION PROCEDURE WAS CARRIED OUT A VALIANT STENT GRAFT WAS IMPLANTED 50% ACROSS THE BRACHIOCEPHALIC ARTERY WITH A CATHETER IN THE PROXIMAL PORTION OF THE ANEURYSM. MULTIPLE COILS WERE THEN PLACED IN THE PROXIMAL PORTION OF THE ANEURYSM WHERE THE TYPE IA ENDOLEAK WAS. FOUR ENDOANCHORS WERE IMPLANTED AT THE PROXIMAL INFERIOR PORTION OF THE GRAFT. THE LEFT SUBCLAVIAN ALSO HAD COILS PLACED THE PREVIOUS WEEK. IT WAS REPORTED THERE WAS VERY LITTLE FLOW INTO THE ANEURYSM AFTER THE DEPLOYMENT, COILING AND ANCHORING. A FOLLOW UP CT COMPLETED TWO DAYS AFTER THE INTERVENTION PROCEDURE CONFIRMED THE T

  Patient problems: Aneurysm; Injury

  MAUDE report 7548166 ↗