VALIANT® Captivia VAMF4242C200TURecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169346536), received between Feb 22, 2017 and Oct 6, 2023 — classified as 1 death, 4 injuries, 2 malfunctions.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 6, 2023Malposition of Device; Malposition of Device

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE TREATMENT OF A 155MM TYPE B AORTIC DISSECTION.  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, FEMORAL ACCESS WAS GAINED BILATERALLY. WIRES WERE PLACED PROPERLY FOLLOWED BY A PIGTAIL MARKER ON THE RIGHT SIDE AND IVUS ON THE LEFT SIDE. THE IVUS USED SHOWED THE LOCATION WAS  IN THE TRUE LUMEN. TRUE LUMEN VERIFICATION WAS ESTABLISHED BASED OFF THE KNOWN VISCERAL VESSELS COMING OFF TRUE LUMEN AND THE AORTIC ARCH VESSELS. MEASUREMENTS WERE TAKEN USING IVUS FOR CONFIRMATION ALONG WITH THE CT SCAN FOR PROPER GRAFT SELECTION . ONCE THE TRUE LUMEN WAS ESTABLISHED A STIFF WIRE WAS ADVANCED INTO THE AORTA PROPERLY AND PROPERLY SEATED AROUND THE ARCH. ONCE THE GUIDEWIRE WAS ESTABLISHED, AN IVUS WAS USED TO MONITOR ALL THE WAY DOWN UNTIL IT EXITED THE PATIENT.  AN AORTOGRAM WITH THE PIG TAIL WAS THEN USED TO NOTE A FOCAL FENESTRATION CAUSING THE DISSECTION. THE 42X42X200 VALIANT CAPTIVIA AORTIC GRAFT WAS THEN PLACED ON THE LEFT WIRE AND  ADVANCED THROUGH THE LEFT FEMORAL ACCESS. ACCESS WAS TIGHT THEREFORE THE DEVICE WAS PULLED OUT AND THE ACCESS WAS PREDILATED WITH A  20FR SHEATH. THE SHEATH WAS REMOVED AND THE VALIANT CAPTIVIA WAS ADVANCED

  Patient problems: Perforation of Vessels

  MAUDE report 17885106 ↗
• MalfunctionApr 5, 2022Defective Component; Positioning Problem; Defective Component; Positioning Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS INTENDED TO BE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, A GAP BETWEEN THE DISTAL EDGE OF THE GRAFT COVER AND THE TAPERED TIP WAS NOTICED AND THE PROCEDURE WAS ABORTED. IT WAS CONFIRMED THE STENT GRAFT WAS INSPECTED PRIOR TO USE AND THE GAP WAS NOTED PRE ITS INSERTION INTO THE PATIENT. PER PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO THE PATIENT'S ANATOMY AND TIGHT CALCIFIED ILIAC ACCESS. IT WAS ALSO NOTED THAT THE GAP MAY HAVE CONTRIBUTED TO DEVICE NOT BEING ABLE TO PASS THROUGH THE COMMON ILIAC ARTERY TO ITS INTENDED IMPLANT SITE IN THE THORACIC AORTA BUT THE GAP WAS PRESENT OUTSIDE THE PATIENT PRIOR TO INSERTION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14011470 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 70MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED DURING INDEX PROCEDURE PRIOR TO PLACING THE VALIANT GRAFT, THE PHYSICIAN PERFORMED A LEFT CAROTID TO LEFT SUBCLAVIAN BYPASS. WHILE ATTEMPTING TO PLUG THE LEFT SUBCLAVIAN ARTERY DISTAL TO THE VERTEBRAL ARTERY THE NON-MDT OCCLUDER KEPT PULLING BACK. THE PHYSICIAN UNSUCCESSFULLY MADE SERVAL ATTEMPTS UNTIL A CLOT WAS IDENTIFIED ON THE OCCLUDER AND IT WAS NOTED THAT THE LONG 7FR. DESTINATION SHEATH HAD NO BLOOD FLOW AND ALSO CONTAINED A CLOT. THE PHYSICIAN THEN DECIDED NOT TO OCCLUDE DUE TO HAVING TO CROSS OVER THE VERTEBRAL ARTERY NUMEROUS TIMES AND ALSO DUE TO THE PRESENCE OF THE CLOT. THE PHYSICIAN THEN IMPLANTED THE VALIANT CAPTIVIA STENT GRAFT AT THE LEVEL OF THE CAROTID ARTERY. THE DAY AFTER THE INDEX PROCEDURE THE PATIENT HAD SYMPTOMS OF APHASIA AND A CT CONFIRMED A STROKE. NO ENDOLEAKS WERE IDENTIFIED. AS PER THE PHYSICIAN THE CAUSE OF THE STROKE WAS DUE TO THE PLACEMENT OF THE NON-MDT DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Dysphasia; Stroke/CVA

  MAUDE report 13017023 ↗
• InjurySep 12, 2018Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM OF UNKNOWN. APPROXIMATELY 8 YEARS PREVIOUSLY THE PATIENT HAD A TALENT ABDOMINAL STENT GRAFT IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF UNKNOWN SIZE. IT WAS REPORTED THAT TYPE IA ENDOLEAKS WERE NOTED AT PATIENT FOLLOW UP ON A UNKNOWN DATE POST THE IMPLANTATION OF THE VALIANT IMPLANT PROCEDURE FOR BOTH THE TALENT STENT GRAFT AND VALIANT STENT GRAFT . IT WAS REPORTED THAT THE PATIENT RECEIVED TREATMENT FOR THE TYPE IA ENDOLEAK OF THE TALENT STENT GRAFT. IT WAS REPORTED THE VISCERAL VESSELS WERE DEBRANCHED USING A MEDTRONIC MANIFOLD TAAA DEVICE AND THE ISSUE WAS RESOLVED. THE TYPE IA ENDOLEAK FOR THE VALIANT STENT GRAFT WAS NOT TREATED. PER THE PHYSICIAN, THE CAUSE OF THE TYPE IA ENDOLEAK ALLEGED AGAINST THE TALENT ABDOMINAL STENT GRAFT EVENT IS DUE TO DEVICE FAILURE. THE CAUSE OF THE TYPE IA ENDOLEAK ALLEGED AGAINST THE VALIANT CAPTIVIA STENT GRAFT IS CURRENTLY UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 7867998 ↗
• InjurySep 26, 2017Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.5 CM IN DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT A RECENT CT REVEALED THAT THERE WAS REMODELING OF THE THORACIC AORTA RESULTING IN A DISTAL TYPE I ENDOLEAK. THE DISTAL END OF THE VALIANT STENT GRAFT IS CURRENTLY 5 CM ABOVE THE CELIAC ARTERY, COMPARED TO A CT PERFORMED ON 7 MONTHS¿ POST IMPLANT WHICH THE DEVICE WAS AT THE CELIAC ARTERY. THE PHYSICIAN ELECTED TO PERFORM AN INTERVENTION BY EXTENDING COVERAGE TO THE LEVEL OF THE CELIAC ARTERY USING A VALIANT [VAMC4646B100TU] STENT GRAFT. THE PHYSICIAN THEN ELECTED TO IMPLANT 4 APTUS ENDOANCHORS IN ORDER TO ANCHOR IT TO THE DISTAL AORTA. THE PATIENT WAS STABLE AFTER THE PROCEDURE AND THE DISTAL TYPE I ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN, THE CAUSES OF THE EVENTS WERE RELATED TO THE PATIENT¿S ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6893711 ↗
• DeathMar 28, 2017Adverse 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 7 CM IN DIAMETER THORACIC ANEURYSM. IT WAS REPORTED THAT FOUR DAYS POST INDEX PROCEDURE THAT THE PATIENT WAS UP WALKING AND SUDDENLY COLLAPSED AND CODED. THE PHYSICIAN STATED THE PATIENT HAD A CAT SCAN THAT REVEALED NO ENDOLEAK PRESENT HOWEVER, THERE WERE BILATERAL PLEURAL EFFUSIONS. THE PHYSICIAN ALSO STATED THAT IT IS POSSIBLE THAT THERE WAS A SMALL TYPE A DISSECTION OF THE ASCENDING AORTA. THE PATIENT WAS KEPT ON LIFE SUPPORT. A BRAIN SCAN WAS PERFORMED WITH DIMINISHED BRAIN FUNCTION; THE FAMILY REQUESTED THE PATIENT BE REMOVED FROM LIFE SUPPORT. THE PATIENT EXPIRED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO PROXIMAL EXTENSION OF THE PERIAORTIC INTRAMURAL HEMATOMA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death; Pleural Effusion; Vascular Dissection

  MAUDE report 6441317 ↗
• MalfunctionFeb 22, 2017Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM ON (B)(6) 2016. IT WAS REPORTED THAT THE FINAL ANGIOGRAM AFTER THE INITIAL PROCEDURE SHOWED DIFFUSED CONTRAST IN THE ANEURYSM. A RECENT ROUTINE FOLLOW UP CT IMAGING DEMONSTRATED CONTRAST IN THE ANEURYSM. THE PHYSICIAN THOUGHT IT WAS EITHER A TYPE IA OR A TYPE III ENDOLEAK. PER THE PHYSICIAN, THE CAUSE OF THE ENDOLEAK WAS UNKNOWN. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THEIR PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6351624 ↗