Valiant Navion™ VNMC4343C218TU (UDI 00763000260941)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000260941), received between Jul 27, 2023 and Jul 27, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 71X85MM TAA . AN OPEN SURGICAL DEBRANCHING PROCEDURE WAS PERFORMED PRIOR TO THE IMPLANT OF THE NAVION STENT GRAFTS. THE VNMC3737C223TU WAS IMPLANTED PROXIMALLY AND VNMC4343C218TU IMPLANTED DISTALLY.  IT WAS REPORTED THROUGH THE SITE THAT CT IMAGING WAS PERFORMED OVER TWO YEARS LATER , WHERE CONTRAST WITHIN THE ANEURYSM SAC WAS NOTED AND A TYPE III ENDOLEAK WAS SEEN.  CORELAB HAVE REVIEWED THE SAME IMAGING AND NOTED THERE IS A IIIB ENDOLEAK IN THE STENT GRAFT VNMC3737C223TU ((B)(6)). NO FRACTURE WAS NOTED. STENT RING ENLARGEMENT  + 1.8MM  WAS NOTED ON RING 8 ON THE STENT GRAFT VNMC4343C218TU ((B)(6)).  NO STENT RING MIGRATION WAS NOTED. THE MAXIMUM DIAMETER MEASURED 81.1MM. AORTIC ENLARGEMENT + 10.6MM WAS OBSERVED. THIS IMAGING WAS COMPARED TO PREVIOUS IMAGING DATED FIVE MONTHS POST THE INDEX PROCEDURE.  THE CAUSE COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm expansion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17404429 ↗