VALIANT® Captivia VAMF2828C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169347007), received between Mar 9, 2017 and Aug 4, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2022Device Damaged by Another Device; Device Damaged by Another Device

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION. THE PATIENT HAS AN EXISTING NON MDT DACRON GRAFT. IT WAS REPORTED THE PATIENT RETURNED FOR A FOLLOW-UP APPROXIMATELY 8 WEEKS POST THE INDEX PROCEDURE . CT IDENTIFIED A PROXIMAL PEAK IRREGULARITY. IT WAS NOTED THAT THE PROXIMAL CROWN OF THE FREE FLO VALIANT CAPTIVIA SEEMED TO PROTRUDE SLIGHTLY THROUGH THE PATIENTS EXISTING DACRON GRAFT PRESENT IN THE ARCH. IT WAS REPORTED ONE DAY LATER THE PATIENT PRESENTED TO ER WITH CHEST PAIN. CT THEN REVEALED GREATER PROTRUSION OF THE VALIANT GRAFT'S PROXIMAL PEAK THROUGH THE EXISTING DACRON GRAFT AND EXTRAVASATION OF CONTRAST. NO TYPE IA ENDOLEAK WAS FOUND. THE NEXT DAY THE PATIENT WAS TAKEN TO OR FOR AN OPEN REPAIR. PATIENT IS CURRENTLY IN ICU. PER THE PHYSICIAN THE CAUSE OF THE PROTRUSION IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Chest Pain

  MAUDE report 15162072 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A DISSECTION .  IT WAS REPORTED THAT A CT REVEALED A SINE AT THE DISTAL PORTION OF THE STENT. THE DISSECTION WAS NOTED TO BE EXTENDING DOWN THE AORTA WITH A 66MM AAA. PER THE PHYSICIAN, THE CAUSE OF THE DISSECTION CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Vascular Dissection

  MAUDE report 13651270 ↗
• InjuryJan 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR A THORACIC ENDOVASCULAR TREATMENT ON (B)(6) 2016. APPROXIMATELY TWO YEARS LATER IT WAS REPORTED BY THE PATIENT VIA TECHNICAL SERVICES THAT THE PATIENT'S STENT GRAFT WAS REMOVED APPROXIMATELY TWO MONTHS PREVIOUSLY BECAUSE IT DIDN'T WORK AND THERE WAS A LARGE RUPTURE. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 8281244 ↗
• InjuryAug 29, 2017Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 25.0 CM THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT THE LEFT COMMON CAROTID ARTERY WAS UNINTENTIONALLY COVERED DURING THE INITIAL PROCEDURE. AN INTRA-OPERATIVE RETROGRADE TYPE A DISSECTION ALSO OCCURRED; WHICH CAUSED MALPERFUSION TO THE CELIAC ARTERY, RENAL ARTERIES, SUPERIOR MESENTERIC ARTERY, AND RIGHT LEG. A CAROTID-CAROTID BYPASS AND ASCENDING AORTIC OPEN REPAIR WERE PERFORMED. THE METAL STRUTS HAD PUNCTURED THROUGH THE AORTA CIRCUMFERENTIALLY. THE PHYSICIAN HAD TO BYPASS THE INNOMINATE ARTERY AND REPLACE THE ASCENDING AORTA BY SEWING TO THE FABRIC OF THE STENT GRAFT AND STENT STRUTS. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE PATIENT IS ALIVE AND STILL IN THE HOSPITAL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED BY THEIR PHYSICIAN.

  Patient problems: Ischemia; Occlusion; Perforation of Vessels; Vascular Dissection

  MAUDE report 6827064 ↗
• InjuryMar 9, 2017Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS SELECTED FOR THE ENDOVASCULAR TREATMENT OF A 250 MM DESCENDING DISSECTION. IT WAS REPORTED THAT A RECENT CT REVEALED A PROXIMAL TYPE I ENDOLEAK THAT WAS FILLING THE FALSE LUMEN. THE PHYSICIAN ELECTED TO IMPLANT 6 APTUS ENDOANCHORS AND USED A RELIANT BALLOON AND THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN THE EXACT CAUSE OF THE PROXIMAL TYPE I ENDOLEAK IS UNKNOWN HOWEVER IT MAY BE RELATED TO THE PATIENT¿S ANATOMY OF PROXIMAL NECK DILATATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6393910 ↗