VALIANT® Captivia VAMF4444C200TU (UDI 00643169346529)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169346529), received between Apr 24, 2018 and Feb 13, 2023 — classified as 2 deaths, 3 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 16, 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.

• InjuryFeb 13, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION (B)(4) STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA . ABOUT EIGHT MONTHS LATER , THE PATIENT WAS IMPLANTED WITH A 7MM NON MDT GRAFT FOR A TYPE IA ENDOLEAK. 9 DAYS LATER, 2 ADDITIONAL DEVICES WERE IMPLANTED PROXIMAL AND DISTAL TO THE ORIGINAL STENT. IT WAS BELIEVED THE TYPE 1A ENDOLEAK WAS ACTUALLY A TYPE IB AT THIS POINT, ALONGSIDE A PERSISTENT TYPE II ENDOLEAK. A STENT GRAFT VNMF4343C103TU WAS IMPLANTED PROXIMALLY AND A 36X36X170 DEVICE WAS IMPLANTED DISTALLY. THE CAUSE OF THE ENDOLEAK WAS DETERMINED TO BE PATIENTS SEVERE HYPERTENSION PRIOR TO AND DURING THE EMERGENCY ADMISSION INCITING THE INITIAL PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 16360897 ↗
• InjuryOct 13, 2022Leak/Splash; Leak/Splash

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION. IT WAS REPORTED APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE FOLLOW UP CT IDENTIFIED A SUSPECTED TYPE III ENDOLEAK. INTERVENTION WAS COMPLETED AND THE ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE TYPE III ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 15593547 ↗
• DeathMar 13, 2019Adverse 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 ENDOVASCULAR TREATMENT OF A MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT A WEEK POST SURGERY THE PATIENT HAD AN ALTERED MENTAL STATUS WITH TRANSIENT CONFUSION OVER TWO DAYS AND WAS FOUND LYING ON THE FLOOR AT HOME. THE PATIENT WAS HOSPITALIZED AND WAS REPORTED TO HAVE INFLUENZA A+ WITH A COUGH AND GENERAL WEAKNESS FOR WHICH THEY WERE MEDICATED. THE PATIENT EXPIRED THE FOLLOWING DAY. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENTS LEADING TO THE DEATH ARE PROCEDURE RELATED BUT NOT DEVICE RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Cardiac Arrest; Confusion/ Disorientation; Death; Intimal Dissection; Virus

  MAUDE report 8415848 ↗
• DeathJul 11, 2018Adverse Event Without Identified Device or Use Problem

  A VALIANT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT ON A 63MM DIAMETER THORACIC AORTIC ANEURYSM. DURING THE INDEX PROCEDURE IT WAS REPORTED THAT AS THE DEVICE WAS BEING ADVANCED THE PATIENTS ARTERIAL PRESSURE DROPPED AND THERE WAS A LOSS OF HEART RHYTHM. THE PROCEDURE WAS CONVERTED TO AN OPEN REPAIR AND IT WAS NOTED THAT THERE WAS A TEAR PRESENT IN THE AORTA DISTAL TO THE LEFT SUBCLAVIAN ARTERY. THE STENT GRAFT WAS PASSED ACROSS THE TEAR AND DEPLOYED. A DISTAL EXTENSION WAS ALSO THEN DEPLOYED. IT WAS REPORTED THAT THE PATIENT EXPIRED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO THE PATIENT HAVING A TYPE 3 AORTIC ARCH. THE PHYSICIAN ADDITIONALLY NOTED THAT NO OVERT AGGRESSIVE PRESSURE WAS EXERTED. IT WAS ALSO NOTED THAT ON OPENING THE CHEST THE AORTA FELT VERY THIN.NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED.

  Patient problems: Death; Loss Of Pulse; Perforation

  MAUDE report 7676819 ↗
• InjuryApr 24, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT ON A CT EXAM PERFORMED APPROXIMATELY 4 MONTHS POST INDEX PROCEDURE, A TYPE IA ENDOLEAK WAS OBSERVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 7454341 ↗