Valiant Navion™ VNMF2222C96TURecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000100537), received between Jul 22, 2020 and Sep 23, 2021 — classified as 1 death, 2 malfunctions.

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 18, 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.

• MalfunctionSep 23, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR AN ENDOVASCULAR TREATMENT. IT WAS REPORTED THE CORELAB OBSERVED AN UNKNOWN ENDOLEAK ON REVIEW OF FOLLOW UP CTS TAKEN APPROXIMATELY 14 MONTHS POST INDEX PROCEDURE. NO CAUSE OF THE EVENT WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12518056 ↗
• MalfunctionSep 7, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION WAS IMPLANTED IN THE PATIENT FOR A TEVAR TREATMENT . APPROXIMATELY 14 MONTHS POST INDEX PROCEDURE, IT WAS REPORTED THE CORELAB OBSERVED AN UNKNOWN ENDOLEAK ON CT. IT WAS ADDITIONALLY REPORTED THERE WAS NO STENT RING ENLARGEMENT OR FRACTURES OBSERVED. NO CAUSE OF THE EVENT HAS BEEN REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12432854 ↗
• DeathJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN OPEN SURGICAL GRAFT THAT HAD BEGUN TO DEGENERATE. IT WAS REPORTED THAT DURING THE DELIVERY OF THE STENT GRAFT VNMF2222C96TU, THE PATIENTS BLOOD PRESSURE SUDDENLY DROPPED. IT WAS INDICATED THAT THE PATIENT'S AORTA RUPTURED DURING THE PROCEDURE. IT WAS STATED THAT THE VALIANT NAVION VNMC2222C94TU WAS ATTEMPTED TO BE IMPLANTED BUT WASN'T, DUE TO AN UNKNOWN REASON. ANOTHER VALIANT NAVION WAS SUCCESSFULLY IMPLANTED TO TREAT THE RUPTURED AORTA. IT WAS REPORTED THAT THE PATIENT EXPIRED THE NEXT DAY. IT WAS REPORTED THERE WASN'T A RELATIONSHIP BETWEEN THE RUPTURE OCCURRING AND ANY SPECIFIC DEVICE USED DURING THE PROCEDURE NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Death; Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 10306812 ↗