VALIANT® Captivia VAMC2828C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169346604), received between Jun 30, 2023 and Aug 10, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE EMERGENT ENDOVASCULAR TREATMENT OF A TYPE B AORTIC DISSECTION.  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE DEVICE DEPLOYED AND A IVUS PERFORMED SHOWED A DISSECTION (PROXIMAL TO THE GRAFT) WHICH WAS CONFIRMED ON TEE ( TRANSESOPHAGEAL ECHOCARDIOGRAPHY) .THE PROCEDURE WAS THEN COMPLETED. IT WAS REPORTED THAT DURING THE DEPLOYMENT OF THE PROXIMAL STENT GRAFT, THE WIRE SLIPPED BACK AND THE DEVICE ADVANCED INTO THE INNOMINATE ARTERY. THE DEVICE WAS THEN PULLED BACK INTO THE DESIRED LOCATION IN THE ARCH- THE WIRE WAS PLACED AT THE ROOT OF THE AORTA AND THE DEVICE PROPERLY DEPLOYED IN THE ARCH OF THE AORTA IN THE DESIRED LOCATION. THE FOLLOWING DAY, THE PATIENT UNDERWENT A HEMI ARCH REPAIR AS TREATMENT.  PERT HE PHYSICIAN, THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Vascular Dissection

  MAUDE report 17497347 ↗
• MalfunctionJun 30, 2023Leak/Splash; Leak/Splash

  TWO VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN THORACIC ENDOVASCULAR PROCEDURE AS PART OF THE APV STUDY. IT WAS REPORTED THAT A CT TAKEN APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE SHOWED AN UNDETERMINED ENDOLEAK ALONG THE INFERIOR THORACIC AORTA AND HAD DECREASED SLIGHTLY SINCE THE PREVIOUS EXAM. THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237742 ↗