VALIANT® Captivia VAMC3232C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169346581), received between Dec 12, 2016 and May 17, 2018 — classified as 1 death, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult To Position” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2018Difficult To Position; Difficult To Position

  A VALIANT STENT GRAFT SYSTEM WAS PLANNED FOR IMPLANTATION IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 65MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AFTER PLACEMENT OF WIRES AND CATHETERS, THE MOST PROXIMAL 24FR VALIANT STENT GRAFT TO BE IMPLANTED WAS INSERTED; HOWEVER, WHILE TRYING TO ADVANCE, ALTHOUGH THE PHYSICIAN WAS PUSHING AS HARD AS POSSIBLE, THE DELIVERY SYSTEM COULD NOT BE ADVANCE. AFTER REMOVAL OF THE DEVICE, ANGIOGRAM SHOWED AN OCCLUSION OF THE DISTAL AORTA AND PROXIMAL COMMON ILIAC ARTERIES. THE PHYSICIAN USED A BALLOON EXPANDABLE STENT IN THE AREA AND THEN SEQUENTIAL DILATORS UP TO 22 FR TO DILATE THE VESSELS. THE PHYSICIAN THEN ATTEMPTED TO PASS THE DEVICE AGAIN, HOWEVER, IT STILL WOULD NOT ADVANCE. A 22FR VALIANT STENT GRAFT WAS THEN ATTEMPTED TO PASS AND THIS WAS SUCCESSFULLY ADVANCED PROXIMALLY TO LAND JUST BEFORE THE LEFT SUBCLAVIAN ARTERY TO TREAT THE TAA. ANOTHER VALIANT STENT GRAFT WAS PLACED JUST ABOVE THE CELIAC ARTERY MORE DISTALLY. IT WAS REPORTED THE NEXT DAY, THE PATIENT WAS PARALYZED FROM THE WAIST DOWN. ATTEMPTS TO PLACE A SPINAL DRAIN AND FLUOROSCOPY DRAIN WERE NOT SUCCESSFUL. ADDITIONALLY, A CSF DRAIN HAD

  Patient problems: Occlusion; Paralysis

  MAUDE report 7521895 ↗
• DeathJan 13, 2017Adverse 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 THE EMERGENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC TYPE A DISSECTION. THE TYPE A DISSECTION CAUSED NEAR OCCLUSION OF THE CELIAC ARTERY, SUPERIOR MESENTERIC ARTERY, RIGHT RENAL ARTERY, AND LEFT COMMON ILIAC ARTERY. THE PATIENT ENTERED SURGERY WITH END ORGAN COMPROMISE. THE DEVICES WERE DEPLOYED ANTEGRADE THROUGH DIRECT EXPOSURE OF THE DESCENDING THORACIC AORTA. IT WAS REPORTED THAT, DURING THE INDEX PROCEDURE, THE PHYSICIAN IMPLANTED THE FIRST VALIANT STENT GRAFT AND THEN ELECTED TO IMPLANT A SECOND VALIANT STENT GRAFT TO GAIN ADDITIONAL PROXIMAL COVERAGE. THE DISTAL END OF THE SECOND VALIANT STENT GRAFT WAS THEN SEWN TO THE PROXIMAL EDGE OF THE THORACIC AORTA. HOWEVER, AFTER THE AORTIC CLAMP TO THE BODY WAS REMOVED, THE PHYSICIAN OBSERVED THAT THE DESCENDING THORACIC AORTA WAS EXPOSED, THAT THE SECOND VALIANT STENT GRAFT WAS PROTRUDING FROM THE AORTA, AND THAT THERE WAS INSUFFICIENT BLOOD FLOW. THE PHYSICIAN ELECTED TO EXPLANT THE VALIANT STENT GRAFTS, IMPLANTED A DACRON GRAFT, AND COMPLETED THE PROCEDURE. HOWEVER, THE PATIENT DID NOT RECOVER AND EXPIRED ON THE OPERATING TABLE. PER THE PHYSICIAN, THE CAUSE OF THE E

  Patient problems: Death; Perforation of Vessels

  MAUDE report 6251915 ↗
• MalfunctionJan 6, 2017Inability to Irrigate; Inability to Irrigate

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS OPENED FOR THE ENDOVASCULAR TREATMENT OF A 20.0 CM THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT WHILE PREPPING THE DEVICE IT WAS NOTICED THAT SALINE WAS NOT REACHING THE STENT GRAFT INSIDE THE DELIVERY SYSTEM AND INSTEAD WAS INTRODUCING AIR INTO THE SYSTEM. A LEAK WAS THEN NOTICED COMING FROM THE SIDE PORT. THE PHYSICIAN DECIDED TO USE ANOTHER DEVICE AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS DEVICE RELATED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6229145 ↗
• MalfunctionDec 12, 2016Material Deformation; Material Deformation

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN EMERGENT THORACIC AORTIC BLUNT FORCE FOCAL TRANSACTION TRANSECTION. IT WAS REPORTED THAT A DISTAL MAIN WAS INADVERTENTLY IMPLANTED INSTEAD OF A PROXIMAL MAIN. IT WAS NOTED THAT AN ASSORTMENT OF DEVICES WERE PULLED TO TREAT THIS PATIENT. AFTER IVUS IMAGING A 32X32X150 VALIANT STENT GRAFT WAS DECIDED UPON. THE STAFF REPORTEDLY PULLED THE DISTAL MAIN DEVICE BY MISTAKE AND IT WAS NOT NOTICED UNTIL THE DEVICE WAS PARTIALLY DEPLOYED. THERE WAS SOME SLIGHT BIRD BEAKING OF THE DEVICE DUE TO THE STEEP AORTIC ANGLE OF THE AORTIC ARCH; BUT THE DEVICE ITSELF WAS PLACED PERFECTLY DISTAL TO THE LEFT SUBCLAVIAN AS PLANNED. IT WAS DECIDED TO LEAVE THE DEVICE AS IS AND NOT EXTEND PROXIMALLY ANY FURTHER; AS THE ANGIOGRAM SHOWED THAT THE TRANSECTION WAS SUCCESSFULLY EXCLUDED AND THE EVENT HAD RESOLVED. THE CAUSE OF THE EVENT WAS NOTED AS USER ERROR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6168195 ↗