VALIANT® Captivia VAMC4444C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169346819), received between Nov 28, 2017 and Nov 15, 2022 — classified as 4 deaths, 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• DeathNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM.  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY WITH CHEST AND ABDOMEN PAIN AND WAS TRANSFERRED TO ANOTHER FACILITY FOR EMERGENT INTERVENTION. A CT PERFORMED SHOWED THE  PATIENTS AORTA HAD  RUPTURED 5 CM SUPERIOR TO THE CELIAC ARTERY, IN THE DISTAL DESCENDING THORACIC AORTA, DISTAL TO EXISTING STENT GRAFT . THE PATIENT RECEIVED 5+ UNITS OF BLOOD PRIOR TO INTERVENTION AND WAS SEVERELY DECOMPENSATED DURING THE TRANSFER. TWO PHYSICIANS STATED THAT THE EXISTING TEVAR LOOKED GREAT WITH NO ENDOLEAKS EVIDENT SINCE THE INDEX PROCEDURE. THE PATIENT HAD BEEN LOST TO FOLLOW-UP.  NEITHER PHYSICIAN REPORTED A DEVICE ISSUE AND REPORTED THAT THE AORTA DEGENERATED AND RUPTURED DISTAL TO THE EXITING 46/46/150 VALIANT CAPTIVIA GRAFT.  EMERGENT INTERVENTION WAS PERFORMED AND A 46/42/150 VALIANT CAPTIVIA WAS IMPLANTED, COVERING THE CELIAC TRUNK AND LANDING SUPERIOR TO THE SMA. NO BALLOONING WAS PERFORMED.  FINAL ANGIOGRAM SHOWED THAT THE RUPTURE WAS COVERED AND THERE WAS GOOD SEAL. AFTER THE EMERGENT PROCEDURE, WHEN THE PATIENT WAS BEING TRANSFERRED TO RECOVERY, THE PATIENT DECOMPENSATED AGAIN,

  Patient problems: Cardiac Arrest; Rupture

  MAUDE report 15796584 ↗
• MalfunctionNov 8, 2021Deformation Due to Compressive Stress; Positioning Problem; Deformation Due to Compressive Stress; Positioning Problem

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS USED DURING A THORACIC ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN ENDOLEAK . IT WAS REPORTED DURING THE INDEX PROCEDURE THE HYPOTUBE OF THE DELIVERY SYSTEM KINKED WHEN IT WAS ATTEMPTING TO BE PASSED THROUGH THE ACCESS SITE. ANOTHER STENT GRAFT WAS IMPLANTED THROUGH THE OPPOSITE ACCESS SITE USING A SECOND DEVICE.  AS PER THE PHYSICIAN THE CAUSE OF THE DEVICE KINK WAS DUE TO PATIENTS ANATOMY AS A RESULT OF TORTUOUS VESSELS.  NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770701 ↗
• DeathMay 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF 75MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY FOUR MONTHS LATER WITH SEVERE CHEST PAIN AND A CT SHOWED A RETROGRADE TYPE A DISSECTION. THE PATIENT UNDERWENT EMERGENCY AORTIC ROOT REPLACEMENT WITH REIMPLANTATION OF THE RIGHT CORONARY WITH AN INSITU SAPHENOUS VEIN GRAFT. AND REPLACEMENT OF THE ASCENDING AORTA. THE EVENT IS REPORTED TO BE RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Death; Intimal Dissection; Pain

  MAUDE report 10060532 ↗
• MalfunctionDec 21, 2018Leak/Splash; Leak/Splash

  VALIANT STENT GRAFT SYSTEMS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 57MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED 3 DAYS POST THE INDEX PROCEDURE AN UNKNOWN ENDOLEAK WAS IDENTIFIED ON FOLLOW UP CT. THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8188897 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT STENT GRAFT SYSTEMS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM OF 57MM DIAMETER. THE PATIENT WAS NOTED TO HAVE MILD/MODERATE AORTIC TORTUOSITY. IT WAS REPORTED THAT APPROXIMATELY 3 WEEKS LATER THE PATIENT PRESENTED WITH A PSEUDO ANEURYSM AT THE SITE OF THE LEFT ARM BRACHIAL ACCESS AREA AND A HEMATOMA IN THE LEFT AM. THE EVENT WAS ASSESSED BY THE INVESTIGATOR TO BE PROCEDURE RELATED. IT WAS REPORTED THE PATIENT WAS HOSPITALIZED ON (B)(6) 2018 AND AN INTERVENTION PROCEDURE WAS CARRIED OUT THE NEXT DAY TO REPAIR THE LEFT BRACHIAL ARTERY ANEURYSM AND REMOVE THE HEMATOMA. THE EVENT WAS REPORTED TO BE RESOLVED WITH GOOD HEALING OF THE INCISION SITE AND A PALPABLE RADIAL PULSE TO THE LEFT WRIST. THE PATIENT WAS DISCHARGED TWO DAYS LATER. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Hematoma; Injury; Pseudoaneurysm

  MAUDE report 7845234 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT STENT GRAFT SYSTEMS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM OF 57MM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, UPON REMOVAL OF THE 26FR SHEATH FROM THE RIGHT COMMON FEMORAL ARTERY, INTIMAL STRIPPING OF THE DISTAL EXTERNAL ILIAC AND PROXIMAL COMMON FEMORAL ARTERY HAD OCCURRED. THIS WAS CONFIRMED BY AN ANGIOGRAPHY. IT WAS ALSO REPORTED THAT ON AN UNKNOWN DATE THE PATIENT HAD A RIGHT FEMORAL THROMBUS. THE PHYSICIAN PLACED A 9X5 VIABAHN COVERED STENT GRAFT AND A 9X37 EXPRESS STENT GRAFT IN THE PATIENT AND REPAIRED THE ANTERIOR SURFACE OF THE RIGHT COMMON FEMORAL ARTERY WITH A BOVINE PERICARDIAL PATCH. COMPLETION ANGIOGRAPHY REVEALED PATENT RIGHT FEMORAL ILIAC SYSTEM AND PALPABLE PULSE IN THE RIGHT FOOT. IT WAS REPORTED THE PATIENT TOLERATED THE PROCEDURE WELL AND THE EVENT WAS RESOLVED. THE INTIMAL FEMORAL STRIPPING IS ASSESSED BY THE INVESTIGATOR AS NOT RELATED TO THE DEVICE BUT RELATED TO THE PROCEDURE. THE SPONSOR HAS REPORTED THE CAUSE OF THE EVENT TO BE PROCEDURE AND DEVICE RELATED. THE THROMBUS HAS NOT BEEN ASSESSED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Intimal Dissection; Thrombus

  MAUDE report 7845225 ↗
• DeathFeb 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 72MM DIAMETER THORACIC AORTIC ANEURYSM. THE PATIENT ALSO HAD A 47MM ABDOMINAL AORTIC PSEUDO-ANEURYSM PROXIMAL AND A 24MM ABDOMINAL AORTIC PSEUDO-ANEURYSM PROXIMAL DISTAL TO PREVIOUS OPEN REPAIR GRAFT, WHICH WAS NOT TREATED. SIZING SHEETS REVEALED AN 11MM IN LENGTH SHORT CONCIAL PROXIMAL NECK WITH MODERATE THROMBUS AND CALCIFICATION OBSERVED IN THE PROXIMAL PSEUDO-ANEURYSM. SEVERE CALCIFICATION WAS ALSO NOTED IN BOTH RIGHT AND LEFT ILIAC ARTERIES. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A THORACIC RUPTURE AND LATER DIED. THE CAUSE OF THE EVENT IS CURRENTLY UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death; Rupture

  MAUDE report 7233842 ↗
• DeathNov 28, 2017Detachment Of Device Component; Difficult to Remove; Device Damaged by Another Device; Detachment Of Device Component; Difficult to Remove; Device Damaged by Another Device

  A VALIANT CAPTIVA STENT GRAFT SYSTEM WAS IMPLANTED SUCCESSFULLY IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 69 MM DIAMETER DESCENDING THORACIC AORTIC ANEURYSM ON (B)(6) 2017. THE ANEURYSM EXTENDED FROM JUST BELOW THE LEFT SUBCLAVIAN ARTERY TO THE CELIAC ARTERY. THE PATIENT HAD A PREVIOUS ABDOMINAL ANEURYSM REPAIR. THE RIGHT SIDE OF THE TALENT STENT GRAFT SYSTEM WAS OCCLUDED. THEREFORE, ONLY THE LEFT SIDE OF THE ABDOMINAL GRAFT WAS PATENT AND AVAILABLE TO USE FOR DEVICE DELIVERY OF THE THORACIC GRAFTS. IT WAS NOTED THAT ON AN UNKNOWN DATE ANOTHER MANUFACTURER¿S STENT WAS IMPLANTED AT THE PROXIMAL LOCATION OF THE TALENT ILIAC LIMB DURING A PREVIOUS SURGERY. IT WAS REPORTED THAT THE FIRST VALIANT STENT GRAFT WAS DEPLOYED, STARTING AT THE TOP OF THE ANEURYSM. THE VALIANT STENT GRAFT DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED FROM THE PATIENT. AN UNKNOWN SHEATH WAS INSERTED FOR THE IMPLANTATION OF THE NEXT VALIANT CAPTIVIA STENT GRAFT. THE PHYSICIAN ATTEMPTED TO CANNULATE THE CELIAC ARTERY, HOWEVER WAS UNSUCCESSFUL AS IT WAS OCCLUDED. THE PHYSICIAN DECIDED TO COVER THE CELIAC ARTERY AND IMPLANT THE SECOND VALIANT CAPTIVIA STENT GRAFT JUST ABOVE THE SMA. THE SECOND VALIANT CAPTIVIA (4

  Patient problems: Death; Perforation of Vessels

  MAUDE report 7062662 ↗