VALIANT® Captivia VAMC4036C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169346710), received between Jan 25, 2017 and Jul 28, 2023 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2023Leak/Splash; Leak/Splash

  TWO VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN UNKNOWN TAA . IT WAS REPORTED THAT A FOLLOW-UP CT TAKEN SHOWED A LARGE TYPE IA AND IB ENDOLEAK. INTERVENTION WAS PERFORMED THE FOLLOWING DAY AND THE PROXIMAL SEAL WAS EXTENDED WITH A NON MDT GRAFT AND THE DISTAL SEAL WAS EXTENDED WITH A MEDTRONIC GRAFT AND REINFORCED WITH ENDOANCHORS. THE ENDOLEKS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAKS WAS PATIENT ANATOMY. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 17412465 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA AND VALIANT NAVION STENT GRAFT SYSTEMS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC ANEURYSMN. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH AORTIC RUPTURE SYMPTOMS. LOCATION OF THE RUPTURE WAS UNKNOWN BUT SUSPECTED TO BE DISTAL TO THE GRAFT. INTERVENTION WAS CARRIED OUT AND THE THORACIC AORTA WAS RELINED AND EXTENDED DISTALLY WITH A NON-MDT GRAFT. NO CAUSE OF THE EVENT WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 12757660 ↗
• InjuryOct 31, 2017Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 8.3 IN DIAMETER THORACOABDOMINAL AORTIC ANEURYSM (TAAA). ONLY THE THORACIC ANEURYSM COMPONENT WAS TREATED AND THE PHYSICIAN PLANNED FOR THE SECOND PART OF THE STAGED PROCEDURE WHICH WAS TO IMPLANT ANOTHER MANUFACTURER¿S BRANCH STENT GRAFT TO TREAT THE VISCERAL AND ABDOMINAL COMPONENTS. HOWEVER, IT WAS REPORTED THAT, APPROXIMATELY 7 MONTHS POST INDEX PROCEDURE, PRIOR TO THE PLANNED SECOND STAGE PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN. IT WAS REPORTED THAT THE CT REVEALED THAT THE ABDOMINAL AORTIC ANEURYSM HAD RUPTURED. THE PHYSICIANS PERFORMED A DEBRANCHING FROM THE LEFT COMMON ILIAC ARTERY (LCIA) TO THE CELIAC, SMA AND RENAL ARTERY. THREE ADDITIONAL VALIANT STENT GRAFTS WERE ALSO IMPLANTED. EXTENDING FROM THE EXISTING VALIANT THORACIC STENT GRAFT TO AORTIC BIFURCATION EFFECTIVELY EXCLUDING ENTIRE AORTA. THE RUPTURED AAA WAS EXCLUDED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO THE PATIENT¿S ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 6990414 ↗
• MalfunctionJan 25, 2017Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6 CM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE FOLLOW UP. THE CT REVEALED THAT THE 44X44X100 VALIANT STENT GRAFT HAD A DISTAL TYPE I ENDOLEAK. THE DISTAL THORACIC AORTA HAD CHANGED FROM 36 MM IN DIAMETER TO 42 MM IN DIAMETER. THE PHYSICIAN IMPLANTED A 40X36X150 VALIANT STENT GRAFT DEPLOYING IT IN THE PREVIOUSLY IMPLANTED PROXIMAL 40X40X100 VALIANT EXTENDING DOWN IN THE NATIVE ARTERY COMPLETELY COVERING THE 44X44X100 VALIANT. HOWEVER, THE DISTAL TYPE I ENDOLEAK DID NOT RESOLVE. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. THE PHYSICIAN STATED THAT THE CAUSE OF THE DISTAL TYPE I ENDOLEAK WAS DUE TO DISEASE PROGRESSION AND DISTAL ANEURYSM DILATION. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6276395 ↗