VALIANT® Captivia VAMF3228C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169400139), received between Jan 28, 2019 and Jun 16, 2025 — classified as 1 death, 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathJun 16, 2025Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A PAU. IT WAS REPORTED THAT THE PATIENT RETURNED FIVE DAYS LATER WITH CONCERNS FOR A POSSIBLE RUPTURE. IT WAS BELIEVED AFTER A CT SCAN WAS PERFORMED, THE AORTA MAY BE MYCOTIC AND WOULD NOW BE RELINED WITH A NON-MEDTRONIC STENT GRAFT. THE PATIENT THEN PASSED AWAY ON AN UNKNOWN DATE. THE CAUSE OF DEATH IS UNKNOWN BUT IT WAS SAID THE PATIENT WAS VERY SICK WITH OTHER CO MORBIDITIES AND HAD PRE-EXISTING ADVANCED UNKNOWN TYPE OF CANCER. A POSSIBLE RUPTURE AND POSSIBLE INFECTION WERE MENTIONED AS WELL AS CONCERNS OF POSSIBLE MYCOTIC INFECTION DETERIORATING THE VALIANT CAPTIVIA GRAFT.

  Patient problems: Insufficient Information; Rupture; Unspecified Infection

  MAUDE report 22210982 ↗
• InjuryAug 10, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION .  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY TO ER WITH CHEST PAIN . A CT PERFORMED SHOWED THE PRESENCE OF A RETROGRADE TYPE A DISSECTION. THE PATIENT HAD OPEN ARCH SURGERY AS TREATMENT OF THE SAME DATE AND THE EVENT RESOLVED.  PER THE PHYSICIAN , IT APPEARED THE RTAD ORIGINATED AT A POINT OF CONTACT WHERE A  SUPRARENAL STENT OF THE STENT GRAFT MADE CONTACT WITH THE AORTIC ARCH AND MAY BE THE CAUSE.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Pain; Vascular Dissection

  MAUDE report 15202367 ↗
• InjuryMay 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 200MM THORACIC AORTIC DISSECTION.  IT WAS REPORTED ON AN UNKNOWN DATE A FEW DAYS AFTER THE INDEX PROCEDURE AND SPINE DRAIN REMOVAL THE PATIENT PRESENTED WITH PARALYSIS. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT MAY BE DUE TO A POSSIBLE HEMATOMA AT THE SPINAL DRAIN SITE. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Hematoma; Paralysis

  MAUDE report 14540007 ↗
• InjuryJan 28, 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 THORACIC ENDOVASCULAR TREATMENT OF A 300 MM ACUTE TYPE B DISSECTION THAT STARTED JUST BELOW THE LEFT SUBCLAVIAN ARTERY. DURING THE INDEX PROCEDURE VALIANT STENT GRAFT VAMF3228C150 WAS IMPLANTED AT THE PATIENTS LEFT CAROTID AFTER PERFORMING A LEFT CAROTID TO LEFT SUBCLAVIAN BYPASS. IT WAS REPORTED THE GRAFT WAS PLACED WITHOUT INCIDENCE AND AN ADDITIONAL VALIANT STENT GRAFT WAS PLACED DISTAL TO THE CELIAC TRUNK. IT WAS REPORTED THAT FINAL ANGIOGRAM SHOWED THE PATIENT HAD A TYPE A RETROGRADE DISSECTION THAT ALSO EXTENDED INTO THE INNOMINATE ARTERY. IT WAS DECIDED TO REPAIR THE ASCENDING DISSECTION. THE BARE SPRINGS OF THE VALIANT STENT GRAFT WERE REMOVED WITH WIRE CUTTERS AND A NON-MDT SYNTHETIC GRAFT WAS SEWN DIRECTLY TO THE VALIANT STENT GRAFT. THE INNOMINATE AND RIGHT CAROTID ARTERIES WERE ALSO RECONSTRUCTED. THE EVENT WAS REPORTED TO BE RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS POSSIBLY CAUSED BY THE PROXIMAL BARE STENTS OF THE STENT GRAFT. IT WAS REPORTED THE BARE SPRING WAS IN THE INNOMINATE ARTERY AND MAY HAVE CAUSED THE DISSECTION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS F

  Patient problems: Intimal Dissection

  MAUDE report 8280662 ↗