VALIANT® Captivia VAMC3434C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169346574), received between Jan 12, 2017 and Apr 23, 2024 — classified as 2 deaths, 1 injury.

The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).

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.

• DeathApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT (VNMC3434C90TU) AND AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL ANEURYSM AND AORTIC DISSECTION. THE PATIENT HAD 2 EXISTING VALAINT CAPTIVIA THORACIC STENT GRAFTS IMPLANTED APPROXIMATELY 3 YEARS PREVIOUS. IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE NAVION IMPLANT PROCEDURE, FOLLOW UP CT SHOWED AN AORTIC DISSECTION AND AORTIC RUPTURE. IT WAS REPORTED THE PATIENT EXPIRED 2 DAYS POST THE CT. PER THE PHYSICIAN THE CAUSE OF THE AORTIC DISSECTION AND RUPTURE IS UNDETERMINED. THE CAUSE OF DEATH WAS DUE TO THE AORTIC DISSECTION.

  Patient problems: Rupture; Vascular Dissection

  MAUDE report 19162019 ↗
• DeathAug 31, 2018Device Damaged by Another Device; Power Problem; Device Damaged by Another Device; Power Problem

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 100MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, IT WAS REPORTED THAT THE GUIDE WIRE WAS MIS-LOCATED. THE GUIDEWIRE WAS RE-ADVANCED AND PASSED THROUGH A SMALL SUB-INTIMAL FLAP. THE STENT GRAFT SYSTEMS WERE THEN DELIVERED AND DEPLOYED OVER THIS WIRE LEADING TO A THORACIC DISSECTION AND PARTIAL OCCLUSION. THE PATIENT RECEIVED BYPASS TREATMENT ON THE SAME DATE BUT PATIENT EXPIRED DUE TO THORACIC INJURY AND OCCLUSION. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS TORTUOUS ANATOMY AND USER ERROR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death; Injury; Intimal Dissection; Occlusion

  MAUDE report 7836936 ↗
• InjuryJan 12, 2017Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A SMALL PENETRATING ULCER THAT WAS APPROXIMATELY 3 CM LONG AND A 7 CM LONG DISTAL AORTIC DISSECTION. THE CELIAC ARTERY HAD BEEN PREVIOUSLY COILED ON AN UNKNOWN DATE PRIOR TO THE INDEX PROCEDURE. THE STENT GRAFTS WERE IMPLANTED APPROXIMATELY 3 CM PROXIMAL TO THE CELIAC ARTERY. IT WAS REPORTED THAT, APPROXIMATELY FOUR MONTHS POST INDEX PROCEDURE, A CT REVEALED THAT THERE WAS FALSE LUMEN PERFUSION AND THAT THE DISSECTION HAD CONTINUED TO INCREASE. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL VALIANT STENT GRAFT DISTAL EXTENSION TWENTY-THREE DAYS LATER. THE DISSECTION WAS SUCCESSFULLY COVERED AND THE EVENT WAS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO DISTAL AORTIC REMODELING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6247275 ↗