Valiant Navion™ VNMF2822C173TURecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000100834), received between Jan 11, 2019 and Jan 25, 2023 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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

• DeathJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION WAS IMPLANTED FOR THE TREATMENT OF A THORACIC ANEURYSM ON (B)(6) 2019. IT WAS REPORTED 7 DAYS POST THE INDEX PROCEDURE FOLLOW UP IMAGING IDENTIFIED AN ESOPHAGEAL AORTIC FISTULA. IT WAS REPORT THAT THE PATIENT EXPIRED APPROXIMATELY 3 MONTHS LATER DUE TO GRAFT INFECTION. PERT HE PHYSICIAN, THE CAUSE OF DEATH WAS A MYCOTIC ANEURYSM AND ESOPHAGEAL AORTIC FISTULA. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Fistula; Unspecified Infection

  MAUDE report 16239295 ↗
• InjuryJan 11, 2019Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF THORACIC AORTA CLOTS. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE NAVION DEVICE WAS DEPLOYED, HOWEVER THE NOSE CONE AND DELIVERY SYSTEM WERE PULLED DOWN AND CAUGHT ON THE DISTAL END OF THE STENT GRAFT. DURING REMOVAL OF THE DELIVERY SYSTEM, THE STENT GRAFT WAS PULLED DOWN FROM THE THORACIC AORTA TO THE ABDOMINAL AORTA. THE STENT GRAFT WAS EXPLANTED AND THE EVENT WAS RESOLVED. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS USER ERROR. IT WAS REPORTED THAT THE RECAPTURE OF TIP TO SHEATH WAS NOT PERFORMED UNDER FLUOROSCOPY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8239192 ↗