VALIANT® Captivia VAMC4440C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169346697), received between Oct 10, 2017 and Mar 8, 2024 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2024Leak/Splash; Leak/Splash

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 82MM TAA. IT WAS REPORTED THAT A FOLLOW-UP CT TAKEN ONE WEEK AFTER THE INDEX PROCEDURE SHOWED A POTENTIAL DELAYED ENDOLEAK, HOWEVER DUE TO THE CONTRAST TIMING DELAY AND SEPARATION OF CHEST AND ABDOMEN SCANS, THE CAUSE AND LOCATION OF THE LEAK WAS UNABLE TO BE PROPERLY IDENTIFIED. IT WAS NOTED THAT THE MINIMUM OVERLAP OF THE DISTAL TAPERED 44X40X150 STENT GRAFT INTO THE DISTAL STRAIGHT 34X34X150 STENT GRAFT WAS DEMONSTRATED ON THE CT TAKEN ON THAT DATE. THE PATIENT WAS SCHEDULED FOR SURGERY AND AN ANGIOGRAM WAS PERFORMED 11 DAYS AFTER THE INDEX PROCEDURE, WHICH IDENTIFIED A TYPE IIIA ENDOLEAK BETWEEN THE 2 VALIANT CAPTIVIA STENT GRAFTS. ANOTHER VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED TO BRIDGE THE TYPE IIIA ENDOLEAK. THE FINAL ANGIOGRAM SHOWED NO ENDOLEAK. PER THE PHYSICIAN, THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. IT WAS NOTED THAT THE ENDOLEAK APPEARED IN SPITE OF APPROPRIATE OVERSIZING IN AN UNSUPPORTED JUNCTION AS WELL AS ACHIEVING MINIMUM OVERLAP. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 18865244 ↗
• InjuryOct 8, 2020Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TYPE 1 ENDOLEAK. IT WAS REPORTED THAT APPROXIMATELY 16 MONTHS POST INDEX PROCEDURE, PATIENT PRESENTED TO THE HOSPITAL WITH A BACK PAIN, A CT WAS PERFORMED WHERE A ENDOLEAK TYPE 1B WAS NOTED. EVENT WAS TREATED WITH A VALIANT NAVION COVERED SEAL. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury; Pain

  MAUDE report 10647826 ↗
• InjuryOct 10, 2017Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF 250MM LENGTH THORACIC AORTIC DISSECTION. THE DISSECTION HAD SPREAD DISTAL TO THE SUPERIOR MESENTERIC ARTERY PRIOR TO THE PROCEDURE. THE DISTAL AORTA MEASURED 36MM IN DIAMETER. IT WAS REPORTED THAT THE THORACIC DISSECTION APPEARED TO BE SEALED BOTH PROXIMAL AND DISTAL AFTER THE FINAL ANGIO AT THE TIME OF THE INDEX PROCEDURE. THE PATIENT RETURNED TO THE HOSPITAL AND THE PHYSICIANS FOUND THE DISTAL SEAL ABOVE THE CELIAC ARTERY TO BE COMPROMISED ALLOWING DYE TO FLOW RETROGRADE INTO ANEURYSM SAC. THE PHYSICIAN MADE MULTIPLE INFLATIONS WITH AN AORTIC BALLOON DISTALLY NOT OBTAINING A SEAL. NO FURTHER INTERVENTION WAS PERFORMED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN. .

  Patient problems: Injury

  MAUDE report 6933743 ↗