Valiant Navion™ VNMC4646C55TU (UDI 00763000101169)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000101169), received between Nov 24, 2020 and Jan 13, 2023 — classified as 2 deaths.

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 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT THORACIC STENT GRAFTS WERE IMPLANTED DURING THE TREATMENT OF A UNKNOWN LENGTH DISSECTION.   IT WAS REPORTED THAT THE PATIENT EXPIRED 5 DAYS POST-INDEX PROCEDURE FROM AORTIC DISSECTION. A INTERVENTION WAS SCHEDULED FOR A REPAIR PROCEDURE BUT THE PATIENT EXPIRED ONE DAY BEFORE.   PER THE PHYSICIAN, THE CAUSE OF THE DISSECTION IS UNKNOWN. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Vascular Dissection

  MAUDE report 16155851 ↗
• DeathNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM AND VALIANT STENT GRAFT WAS IMPLANTED IN A PATIENT DURING AN UNKNOWN AORTIC ENDOVASCULAR PROCEDURE. IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM. A CT SCAN IDENTIFIED A TYPE IA ENDOLEAK AND RUPTURED AAA. THE PATIENT EXPIRED ON THE DAY OF THE RUPTURE. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK RUPTURE AND DEATH IS UNDETERMINED.

  Patient problems: Ruptured Aneurysm

  MAUDE report 10894861 ↗