Valiant Navion™ VNMF2828C174TU (UDI 00763000100582)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000100582), received between Nov 22, 2022 and Jan 23, 2023 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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.

• DeathJan 23, 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 A SACCULAR THORACIC AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 8 MONTHS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH AMS. ON EVALUATION SEPSIS WAS SUSPECTED DUE TO A GRAFT INFECTION. THE PATIENT WAS NOTED TO BE A VERY POOR SURGICAL CANDIDATE AND INSTEAD A COURSE OF ANTIBIOTICS WAS CONSIDERED HOWEVER THE PATIENT EXPIRED BEFORE PROGRESSION OF TREATMENT. PER THE PHYSICIAN THE CAUSE OF THE INFECTION AND DEATH ARE UNDETERMINED.

  Patient problems: Cognitive Changes; Sepsis; Unspecified Infection

  MAUDE report 16223487 ↗
• InjuryNov 22, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR PROCEDURE OF A THORACIC DISSECTION .  IT WAS REPORTED THAT FOLLOW UP CT  THE FOLLOWING MONTH IDENTIFIED A TYPE IA ENDOLEAK. THERE WAS NO STENT FRACTURE , STENT RING ENLARGEMENT OR STENT RING DISPLACEMENT OBSERVED.  INTERVENTION WAS CARRIED OUT WHERE A SECOND VALIANT NAVION WAS IMPLANTED LESS THAN 2 WEEKS LATER TO TREAT THE ENDOLEAK. NO CAUSE PROVIDED. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 15841724 ↗