Valiant Navion™ VNMF4343C183TU (UDI 00763000100766)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000100766), received between May 22, 2023 and Jul 17, 2023 — classified as 1 death, 1 injury.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 12, 2021Class IOpen, Classified

   Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.

   Z-1201-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• DeathJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ULCER. IT WAS REPORTED THAT A FOLLOW-UP CT TAKEN APPROXIMATELY 5 MONTHS POST THE INDEX PROCEDURE SHOWED THE SACCULAR ANEURYSM OF THE DISTAL THORACIC AORTA MEASURING UP TO 40MM. IT WAS REPORTED THE PATIENT EXPIRED APPROXIMATELY 15 MONTHS POST THE INDEX PROCEDURE. THE CAUSE OF THE ANEURYSM ENLARGEMENT AND DEATH ARE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Aneurysm

  MAUDE report 17331315 ↗
• InjuryMay 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE TREATMENT OF A TYPE IB ENDOLEAK IN AN EXISTING VALIANT NAVION STENT GRAFT ON (B)(6)2020. THE ANEURYSM SAC DIAMETER WAS NOTED TO MEASURE 95MM AND THE PATIENT WAS ASYMPTOMATIC. AN EXISTING VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM ON (B)(6)2019. ENDOANCHORS WERE ALSO IMPLANTED ON AN UNKNOWN DATE. IT WAS REPORTED ON AN UNKNOW DATE IN 2021, A REVISION OF THE THORACOABDOMINAL ENDOGRAFT REPAIR WAS PERFORMED IN 2021 WITH REVISION OF THE ANEURYSM SAC, DRAINAGE OF FLUID AND REMOVAL OF THROMBUS. IT WAS REPORTED THAT THE PATIENT HAD A LEFT THORACOABDOMINAL WOUND POST THE 2021 ANEURYSM SAC REVISION. NO CAUSE WAS PROVIDED. NO ADDITIONAL SEQUALAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 16972603 ↗