VALIANT® Captivia VAMF4040C150TU (UDI 00643169346949)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169346949), received between Apr 18, 2017 and Mar 11, 2021 — classified as 2 deaths, 5 injuries.

The most frequently reported specific device problem is “Leak/Splash” (4 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.

• InjuryMar 11, 2021Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 77 MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 21 MONTHS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL WITH CHEST PAIN AND BACK PAIN. A CT WAS PERFORMED, WHERE IT SHOWED WHAT APPEARED TO BE AN TYPE 1A ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11463713 ↗
• InjuryNov 26, 2020Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 50MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED WHEN THE PATIENT RETURNED FOR FOLLOW-UP FOUR YEARS LATER , A DISTAL TYPE IB ENDOLEAK WAS IDENTIFIED. INTERVENTION WAS PERFORMED THE NEXT DAY AND TWO VALIANT NAVION DEVICES PLUS AN ENDURANT LIMB (ETLW1620C93E) WAS IMPLANTED AS TREATMENT. IT WAS STATED IMMEDIATELY AFTER THE PROCEDURE, THE PATIENT WAS FOUND TO BE PARALYZED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Paralysis

  MAUDE report 10911001 ↗
• InjuryJan 20, 2020Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 80MM THORACIC AORTIC ANEURYSM. ANOTHER VALIANT CAPTIVA STENT GRAFT WAS ALSO IMPLANTED TEN MONTHS LATER. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY TWO YEARS AND EIGHT MONTHS POST THE LAST IMPLANT WITH SYMPTOMS OF A RUPTURED ANEURYSM. A CT WAS PERFORMED AND SHOWED AN ENDOLEAK. IT WAS REPORTED THAT THE PHYSICIAN BELIEVED THIS WAS A TYPE IIIA ENDOLEAK DUE TO AN INADEQUATE OVERLAP BETWEEN GRAFT PIECES. THIS ENDOLEAK WAS TREATED AND THE PATIENT WAS BROUGHT TO OR WHERE ANOTHER STENT GRAFT WAS IMPLANTED, THIS SUBSEQUENTLY RESOLVED THE EVENT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS INADEQUATE OVERLAP BETWEEN GRAFT PIECES. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 9606908 ↗
• InjuryJun 28, 2018Difficult To Position; Difficult To Position

  A VALIANT STENT GRAFT SYSTEM WAS PLANNED TO BE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50-60MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE THAT THE DEVICE FAILED TO TRACK THROUGH THE CALCIFIED AORTA AND THE RIGHT ILIAC SUSTAINED A TEAR. THE PHYSICIAN ELECTED NOT TO IMPLANT THE VALIANT DEVICE AND AN OPEN REPAIR OF THE EXTERNAL ILIAC WAS COMPLETED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO CALCIFIED ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Perforation of Vessels

  MAUDE report 7645279 ↗
• DeathDec 6, 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 EMERGENT ENDOVASCULAR TREATMENT OF A RUPTURED 36MM DIAMETER THORACIC AORTIC ANEURYSM. A VALIANT CAPTIVIA 36X36X200 STENT GRAFT WAS PLACED PROXIMALLY AND A 40X40X200 WAS PLACED DISTALLY. HOWEVER, IT WAS REPORTED THAT, DURING DELIVERY OF A THIRD VALIANT CAPTIVIA (40X40X150), THE PATIENT LOST A-LINE PRESSURE. THE PHYSICIAN THEN REMOVED THE 40X40X150 WITHOUT ATTEMPTING DEPLOYMENT, AND PLACED A RELIANT BALLOON IN THE THORACIC AORTA TO OCCLUDE BLOOD FLOW. DESPITE ATTEMPTS TO RESUSCITATE, THE PATIENT DIED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMICAL DUE TO THE RUPTURE OF THE TORTUOUS THORACIC AORTA. NO OTHER CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death

  MAUDE report 7085954 ↗
• InjuryJul 10, 2017Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  A VALIANT STENT GRAFT SYSTEM WAS INSERTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.2 CM IN DIAMETER ASCENDING THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE ANEURYSM IN THE ASCENDING AORTIC ANEURYSM WAS MOST LIKELY DUE TO AN ANASTAMOSIS FROM A PREVIOUS PROCEDURE OF HEART TRANSPLANT. THE PHYSICIAN WANTED TO AVOID AN OPEN REPAIR A PREVIOUS TRANSPLANT PATIENT AND CHOSE TO UTILIZE VALIANT STENT GRAFTS. THE PHYSICIAN MODIFIED THE VALIANT STENT GRAFT PRIOR TO THE INSERTION INTO THE PATIENT, SHORTENING THE VALIANT 40X40X150 GRAFT TO 80MM AND DEPLOYED IT IN A TRANSAPICAL APPROACH, TRYING TO LAND WITH THE GRAFT BETWEEN THE BRACHIOCEPHALIC ARTERY AND THE SINOTUBULAR JUNCTION. DURING DEPLOYMENT, THE VALIANT STENT GRAFT MOVED FORWARD AT THE END AND WAS 1CM DISTAL TO WHERE THE STENT GRAFT WAS INTENDED TO BE IMPLANTED. THERE WAS A PROXIMAL TYPE I ENDOLEAK AT THAT TIME. THE PHYSICIAN DECIDED TO USE A SECOND VALIANT STENT GRAFT, SHORTENING 40X36X150 TO 80 MM AND TRY TO LAND MORE PROXIMAL, RIGHT AT THE SINOTUBULAR JUNCTION. PREPARING TO DEPLOY THE SECOND VALIANT STENT GRAFT, IT WAS NOTICED THAT THE FIRST GRAFT HAD MIGRATED DISTALLY ABOUT 1CM. IT WAS NOW COVERING 85% OF THE BRACHIOCEPH

  Patient problems: Injury

  MAUDE report 6699386 ↗
• DeathApr 18, 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 TYPE B DISSECTION FROM THE LEFT SUBCLAVIAN ARTERY EXTENDING DISTALLY TO RIGHT EXTERNAL ILIAC ARTERY. IT WAS REPORTED THAT APPROXIMATELY 4 HOURS POST IMPLANT THE PATIENT¿S BLOOD PRESSURE DROPPED. AN ECHOCARDIOGRAM REVEALED THAT THE PATIENT HAD A TYPE A RETROGRADE DISSECTION WITH OCCLUSION OF RIGHT CORONARY ARTERY RESULTING IN A MASSIVE RIGHT VENTRICULAR INFARCT. THE PATIENT EXPIRED. PER THE PHYSICIAN, THE CAUSES OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death; Myocardial Infarction; Occlusion

  MAUDE report 6500440 ↗