VALIANT® Captivia VAMC4238C150TU (UDI 00643169346703)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169346703), received between May 16, 2017 and Oct 11, 2022 — classified as 1 death, 3 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 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.

• InjuryOct 11, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 67MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE,  THE EXTERNAL ILIAC ARTERY  WAS TORN UPON INSERTION OF THE DEVICE. IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE DROPPED UNTIL THE PELVIS WAS OPENED AND THE BLEEDING WAS CONTROLLED. THE  DAMAGED VESSEL WAS  SURGICALLY REPAIRED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED TO A SMALL EXTERNAL ILIAC ARTERY. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 15576232 ↗
• DeathMay 5, 2022Adverse 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 68MM THORACIC AORTIC ANEURYSM . THE PHYSICIAN IMPLANTED A VAMF3838C150TU FOLLOWED BY VAMC4238C150TU PROXIMAL TO CELIAC. IT WAS REPORTED DURING THE INDEX PROCEDURE FOLLOWING THE IMPLANT OF THE TWO VALIANT CAPTIVIA STENT GRAFTS, BALLOONING WAS COMPLETED WITH RELIANT BALLOON AT THE OVERLAP SECTION AND DISTAL GRAFT SEAL ZONE. ON THE FINAL ANGIOGRAM A TYPE IA ENDOLEAK WAS OBSERVED. THE PHYSICIAN AT FIRST THOUGHT IT WAS AS A RESULT OF THE PATIENT ANATOMY MEASURING 33-35MM. THE PHYSICIAN BALLOONED THE TOP OF THE GRAFT WHICH IMPROVED THE ENDOLEAK. ANOTHER ANGIOGRAM WAS PERFORMED AND THE GRAFT WAS THEN EXTENDED PROXIMALLY WITH A VAMF3838C100TU. BALLOONING OF THE OVERLAP OF GRAFT WAS PERFORMED WITH RELIANT BALLOON. FINAL ANGIOGRAM SHOWED NO ENDOLEAK AND CASE WAS A TECHNICAL SUCCESS. POSTPROCEDURE, A FEW HOURS LATER, THE PHYSICIAN NOTED THE PATIENT HAD WOKEN UP AND WAS MOVING ALL EXTREMITIES, BUT THEN THE PATIENT CODED AND CPR WAS COMMENCED BUT THE PATIENT EXPIRED. AS PER THE PHYSICIAN THE CAUSE OF DEATH COULD HAVE BEEN DUE TO A TYPE A DISSECTION, BUT WITHOUT IMAGING THE PHYSICIAN WAS NOT CERT

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 14285320 ↗
• InjurySep 12, 2019Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 56 MM ABDOMINAL AORTIC ANEURYSM. A VALIANT NAVION STENT GRAFT SYSTEM WAS ALSO IMPLANTED DURING THE PROCEDURE FOR TREATMENT OF A THORACIC TYPE IIIB ENDOLEAK. A TALENT STENT GRAFT SYSTEM WAS PREVIOUSLY IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM AND A BYPASS TO THE VISCERAL VESSELS WAS ALSO REPORTED TO HAVE BEEN CARRIED OUT. A VALIANT CAPTIVIA STENT GRAFT WAS ALSO IMPLANTED IN THE PATIENT FOR TREATMENT OF A TYPE IB ENDOLEAK. THE TYPE IIIB ENDOLEAK ORIGINATED FROM THE PREVIOUSLY IMPLANTED VALIANT CAPTIVIA AND TALENT STENT GRAFT SYSTEMS. IT WAS REPORTED THE ENDURANT IIS SYSTEM WAS IMPLANTED INFRARENALLY AND THEN THE NAVION VALIANT SYSTEM WAS IMPLANTED. IT WAS REPORTED THAT THE PROCEDURE WENT WELL, HOWEVER, TWO HOURS POST-PROCEDURE IT WAS REPORTED THAT THE PATIENT WAS PARALYZED. AS PER THE PHYSICIAN, THE CAUSE OF THE PARALYSIS WAS DUE TO THE PATIENT¿S ANATOMY. IT WAS REPORTED THAT THE CSF DRAIN WAS IMPLANTED PRIOR TO THE PROCEDURE BUT DUE TO THE LENGTH OF THE COVERAGE REQUIRED (FROM THE LSA TO COMMON ILIAC ARTERIES BILATERALLY), THE PATIENT BECAME P

  Patient problems: Injury

  MAUDE report 9007379 ↗
• InjuryJul 12, 2017Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 90MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED TO ER WITH BACK PAIN. A CTA WAS DONE AND REVEALED SEPARATION OF THE PREVIOUSLY IMPLANTED THORACIC STENT GRAFTS. INTERVENTION WAS PERFORMED AND THE PHYSICIAN BRIDGED THE STENT GRAFTS SEPARATION WITH A 46/46/200 VALIANT STENT GRAFT. PER THE PHYSICIAN THE EVENT IS ANATOMY RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 6709399 ↗
• MalfunctionMay 16, 2017Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 7CM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT A RECENT CT DEMONSTRATED A DISTAL TYPE I ENDOLEAK AND THE ANEURYSM IS CURRENTLY 8.8CM IN DIAMETER. PER THE PHYSICIAN, THE CAUSE OF THE DISTAL TYPE I ENDOLEAK IS RELATED TO THE PATIENT¿S ANATOMY; DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6570939 ↗