VALIANT® Captivia VAMF4444C100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169347335), received between Jul 5, 2017 and Nov 20, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (2 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.

• InjuryNov 20, 2019Adverse 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 THORACIC AORTIC ANEURYSM. A HELI-FX APPLIER AND GUIDE WERE ALSO USED DURING THE PROCEDURE. TWO NON-MEDTRONIC STENTS WERE ALSO IMPLANTED. IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS POST PROCEDURE, A GROIN INFECTION OCCURRED. THE PATIENT'S LEFT GROIN WAS DEHISCED AS TREATMENT AND MEDICATION WAS ADMINISTERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE STUDY DEVICE OR INDEX PROCEDURE. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE STUDY DEVICE, RELATED TO THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Unspecified Infection

  MAUDE report 9346563 ↗
• MalfunctionMay 29, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT ON CT EXAM APPROXIMATELY 4 MONTHS LATER A TYPE IA ENDOLEAK WAS OBSERVED. INTERVENTION WAS PERFORMED TO ADDRESS THE TYPE IA ENDOLEAK WITH THE IMPLANTATION OF A 44X44X100 VALIANT STENT GRAFT PROXIMALLY. IT WAS REPORTED THAT THE STENT GRAFT WAS PLACED PERFECTLY, BUT THERE WAS AN ENDOLEAK PROXIMALLY EITHER TYPE IA OR TYPE II ENDOLEAK. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7548221 ↗
• InjuryJul 5, 2017Leak/Splash; Leak/Splash

  AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN. THERE WAS STENT GRAFT MIGRATION WITH SAC ENLARGEMENT, BUT NO EVIDENCE OF AN ENDOLEAK. AT THAT TIME, THE PHYSICIAN ELECTED TO MONITOR THE PATIENT, AS THE PATIENT HAD NON-STENT GRAFT RELATED ISSUES, THAT WERE MEDICALLY A HIGHER PRIORITY. IT WAS REPORTED THAT THE PATIENT RETURNED EMERGENTLY WITH ABDOMINAL PAIN. THE CT REVEALED THAT THE ANEURX STENT GRAFT CONTINUED TO MIGRATE DISTALLY WITH TYPE I ENDOLEAK. AN ENDURANT AORTIC CUFF, AND TWO VALIANT STENT GRAFTS WERE IMPLANTED INTENTIONALLY COVERING THE RENAL ARTERIES AS THE PATIENT WAS ALREADY RECEIVING DIALYSIS, AND SNORKELING OF THE SMA WAS PERFORMED. THE MIGRATION AND PROXIMAL TYPE I ENDOLEAK WERE RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE MIGRATION AND PROXIMAL TYPE I ENDOLEAK WERE DUE TO PATIENT ANATOMY. THE PATIENT PRESENTED FOR FOLLOW UP. THE CT REVEALED A PROXIMAL TYPE I ENDOLEAK OF THE VALIANT STENT GRAFT, AND WAS REFERRED TO ANOTHER FACILITY. ANOTHER PHYSICIAN PERFORMED AM OPEN REPAIR. THE OPEN REPAIR CONSISTED OF REMOVAL OF THE ENDURANT AORTIC CUFF, THE TWO

  Patient problems: Pain

  MAUDE report 6688387 ↗