Valiant Navion™ VNMF3737C229TU (UDI 00763000260484)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000260484), received between Jan 5, 2021 and Feb 17, 2021 — classified as 1 death, 1 injury.

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

• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TYPE B AORTIC DISSECTION. THE PATIENT HAD PRESENTED TWO DAYS PRIOR WITH THE DISSECTION AND RIGHT LEG ISCHEMIA. IT WAS REPORTED ON THE DATE OF THE CT, THE PATIENT WAS DIAGNOSED WITH A TYPE A AORTIC DISSECTION. THE PATIENT HAD COMPLAINTS OF BACK PAIN FOR A COUPLE OF WEEKS AND HAD SEVERE CHEST PAIN ON THE DAY OF THE CT. THE PATIENT WAS TAKEN TO OPERATING ROOM WHERE A SURGICAL REPAIR OF THE DISSECTION WAS PERFORMED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Pain; Vascular Dissection

  MAUDE report 11337001 ↗
• DeathJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS AND AN ENDURANT AORTIC EXTENSION CUFF WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 305MM THORACIC AORTIC ANEURYSM. A DAY LATER, THE PATIENT HAD A RETROGRADE TYPE A AORTIC DISSECTION AND EXPIRED BEFORE REACHING THEATRE. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Vascular Dissection

  MAUDE report 11116173 ↗