VALIANT® Captivia VAMF4242C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169346932), received between Apr 14, 2017 and Jul 21, 2021 — classified as 2 deaths, 6 injuries.

The most frequently reported specific device problem is “Leak/Splash” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• DeathJul 21, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM ANOTHER VALIANT STENT GRAFT WAS THEN IMPLANTED JUST OVER A MONTH LATER. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY OVER THREE YEARS LATER OUTSIDE THE HOSPITAL WITH COMPLAINTS OF EPIGASTRIC PAIN. A CT WAS THEN PERFORMED WHICH REVEALED A 90 MM RUPTURED ANEURYSM AND A TYPE III ENDOLEAK WHICH LOOKED TO BE COMING FROM THE OVERLAP BETWEEN STENTS. INTERVENTION WAS PERFORMED WHERE 2 X VALIANT STENT VAMF4242150 WERE IMPLANTED WHICH APPEARED TO SEAL THE ENDOLEAK. BUT THE PATIENT THEN WENT INTO CARDIAC ARREST, CPR WAS COMMENCED BUT THE PATIENT COULD NOT BE REVIVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNKNOWN. THE PHYSICIAN BELIEVES THE PATIENT MAY HAVE SUFFERED A MYOCARDIAL INFRACTION DURING THE PROCEDURE. THE CAUSE OF DEATH WAS ALSO STATED TO BE RELATED TO THE TYPE III ENDOLEAK AND RUPTURE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Myocardial Infarction; Pain; Rupture

  MAUDE report 12201803 ↗
• InjuryOct 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO VALIANT CAPTIVIA STENT GRAFT EXTENSIONS WERE IMPLANTED IN A PATIENT AS PART OF A CLINICAL TRIAL FOR THE VALIANT MONO LSA STENT GRAFT SYSTEM. AN ADDITIONAL VALIANT CAPTIVIA STENT GRAFT WAS ALSO IMPLANTED IN THE PATIENT APPROXIMATELY ONE YEAR LATER. A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT TWO YEARS LATER AS PART OF A TEVAR PROCEDURE. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY NINE MONTHS LATER WITH ABSENT PULSE IN THE LEFT UPPER EXTREMITY WITH COOL DUSKY FINGERS AND THE PATIENT WAS DIAGNOSED WITH A THROMBOEMBOLISM. THE THROMBUS WAS EVACUATED FROM THE PATIENT TO RESOLVE THE EVENT. THE INVESTIGATOR HAS ASSESSED THE EVENT AS RELATED TO THE PROCEDURE AND NOT RELATED TO THE DEVICE. THE SPONSOR HAS ASSESSED THE EVENT AS NOT RELATED TO THE STUDY INDEX PROCEDURE OR DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Embolism; Stroke/CVA

  MAUDE report 9144786 ↗
• DeathJun 18, 2019Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 3.5 YEARS POST IMPLANT, THE PATIENT WAS ADMITTED TO HOSPITAL FOR ABDOMINAL PAIN AND A POSSIBLE ENDOLEAK. A CT SCAN DEMONSTRATED AN ENDOLEAK. PER THE PHYSICIAN, THE ENDOLEAK APPEARS TO BE A WORSENING CONDITION FROM THE DISEASE THAT WAS TREATED VIA SURGICAL INTERVENTION SEVEN MONTHS PREVIOUSLY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Abdominal Pain; Death; Hemoptysis; Occlusion

  MAUDE report 8706933 ↗
• InjurySep 21, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 65MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 18 MONTHS LATER, A CT SCAN IDENTIFIED A TYPE IA ENDOLEAK. PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. A CAROTID-CAROTID BYPASS WAS CARRIED OUT ON (B)(6) 2018 AND AN ENDOVASCULAR INTERVENTION PROCEDURE WAS ALSO CARRIED OUT ON (B)(6) 2018. A 44X44X100 VALIANT STENT GRAFT WAS IMPLANTED PROXIMALLY TO RESOLVE THE TYPE IA ENDOLEAK. A 44X44X100 DISTAL STENT GRAFT EXTENSION WAS ALSO IMPLANTED PROPHYLACTICALLY TO INCREASE THE SEAL ZONE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7897283 ↗
• InjuryJun 20, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 2 YEARS POST INDEX PROCEDURE WITH TYPE 1B ENDOLEAK. A REINTERVENTION PROCEDURE WAS COMPLETED WHERE AN ADDITIONAL VALIANT STENT GRAFT WAS IMPLANTED TO EXTEND THE DISTAL SEAL ZONE TO JUST PROXIMAL OF THE CELIAC ARTERY. THE ENDOLEAK WAS CONFIRMED AS RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION OF DISTAL THORACIC AORTA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7618218 ↗
• InjuryMay 30, 2018Difficult To Position; Difficult To Position

  A VALIANT STENT GRAFT SYSTEM WAS PLANNED FOR IMPLANTATION IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN ATTEMPTED TO INSERT THE DEVICE BUT ONCE AT THE AORTIC ARCH IT WOULD NOT PASS OVER THE ARCH, EVEN AFTER SEVERAL ATTEMPTS. DURING THIS PROCESS THE ILIAC VEIN TORE AND THE DEVICE WAS REMOVED TO GET CONTROL OF THE ILIAC VEIN. HE THEN ATTEMPTED TO PASS THE DEVICE AGAIN BUT IT WOULD STILL NOT PASS. ANOTHER LONGER STENT GRAFT WAS THEN USED WHICH WAS SUCCESSFULLY DEPLOYED AND IMPLANTED TO COMPLETE THE PROCEDURE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Perforation of Vessels

  MAUDE report 7552087 ↗
• InjuryOct 31, 2017Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 67 MM IN DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT ON FOLLOW UP CT IMAGING THE PHYSICIAN OBSERVED A PROXIMAL TYPE 1 ENDOLEAK AT THE SEAL ZONE. THE PHYSICIAN IMPLANTED A VALIANT 42 X 42 X 200 STENT GRAFT SYSTEM EXTENDING PROXIMAL TO THE LEFT SUBCLAVIAN ARTERY, RESOLVING THE PROXIMAL TYPE 1 ENDOLEAK. THE PHYSICIAN HAS STATED THAT THE CAUSE OF THE EVENT IS RELATED TO THE PATIENT'S ANATOMY; ENLARGEMENT OF THE PROXIMAL SEAL ZONE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6990550 ↗
• InjuryApr 14, 2017Adverse 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 A 33.0 CM IN LENGTH THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH AN ENLARGING THORACIC ANEURYSM FOLLOWING THORACIC ENDOVASCULAR REPAIR (TEVAR) FOR A TYPE B AORTIC DISSECTION (TBAD). IT WAS ALSO REPORTED THAT THERE WAS A TYPE II ENDOLEAK AND AN EXPANDING TBAD FALSE LUMEN WITH MULTIPLE NEW NATIVE FENESTRATIONS IN THE INTIMA. THERE WERE MULTIPLE NATIVE FENESTRATIONS IN THE DESCENDING THORACIC AORTA INTIMA AND ABDOMINAL AORTA INTIMA. THE PHYSICIAN STATED THAT THE CAUSE APPEARED TO BE THE LEFT SUBCLAVIAN ARTERY (LSA) PERFUSING THE FALSE LUMEN AFTER THE INDEX PROCEDURE, WHERE AN LCA TO LSA BYPASS WAS PERFORMED; AS WELL AS A LARGE DISTAL FENESTRATION WHICH WAS PROVIDING DISTAL FLOW IN THE FALSE LUMEN. BOTH WERE SUSPECTED TO BE CONTRIBUTING TO THE CONTINUED GROWTH. THE LSA WAS EMBOLIZED AND A DISTAL EXTENSION WAS PLACED THAT EXTENDED COVERAGE FROM THE MID DESCENDING THORACIC ANEURYSM TO THE SUPERIOR MESENTERIC ARTERY. THIS REPORTEDLY RESOLVED THE EVENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm; Vascular Dissection

  MAUDE report 6495575 ↗