Valiant Navion™ VNMC2822C207TURecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000101213), received between Jan 15, 2019 and Mar 13, 2025 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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.

• InjuryMar 13, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT WHO WAS TREATED FOR A 45-MILLIMETER ANEURYSM WITH A VALIANT NAVION STENT GRAFT EXPERIENCED A PROXIMAL AND DISTAL ENDOLEAK. THE EVENT WAS DISCOVERED ON THE DATE OF A CT SCAN PERFORMED APPROXIMATELY 4 YEARS AND 9 MONTHS POST-INDEX PROCEDURE. DEGENERATION OF THE AORTA AT THE PROXIMAL AND DISTAL EDGE OF THE GRAFT WAS ALSO NOTED. THE PATIENT UNDERWENT TREATMENT WITH THE ADDITION OF PROXIMAL AND DISTAL EXTENSIONS USING A STENT GRAFT, RESOLVING THE ENDOLEAK. THE CAUSE OF THE ENDOLEAKS COULD NOT BEDETERMINED BY THE HEALTHCARE PROFESSIONAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21596227 ↗
• DeathJan 15, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AN ATTEMPT WAS MADE TO IMPLANT A VALIANT NAVION STENT GRAFT IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A PAU. THE MINIMUM DIAMETERS OF THE LEFT AND RIGHT ILIAC ARTERIES WERE 4 MM AND 5.4 MM, RESPECTIVELY. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN DILATED THE RIGHT ILIAC ARTERY WITH A BALLOON AND ADVANCED AN 18 FR AND A 20 FR NON-MEDTRONIC SHEATH. THE PHYSICIAN THEN ATTEMPTED TO DELIVER THE NAVION DEVICE, HOWEVER IT COULD NOT PASS THROUGH THE ILIAC ARTERY. AFTER RETRIEVING THE NAVION DEVICE FROM THE ILIAC, THE PHYSICIAN NOTICED EXTRAVASATION IN THE ILIAC, INDICATING THERE WAS A TEAR IN THE ARTERY. THE PHYSICIAN REPAIRED THIS WITH A NON-MEDTRONIC STENT. IT WAS ALSO NOTED THAT THE ILIAC WAS LEAKING DISTAL TO THIS TEAR AND THE PHYSICIAN CARRIED OUT A SURGICAL REPAIR. AFTER REPAIRING THE DISTAL TEAR, THE PHYSICIAN ATTEMPTED TO ADVANCE THE NON-MEDTRONIC (GORE) 20 FR DRY SEAL SHEATH AND IT TORE THE ARTERY IN HALF. THE PHYSICIAN THEN REPAIRED THIS TEAR SURGICALLY AND ALSO PERFORMED A BI-FEMORAL BYPASS DUE TO THE FRAGILE NATURE OF THE PATIENT'S AORTA AND THE DIFFICULTY IN REPAIRING THE TEAR. THE PATIENT LOST A LARGE AMOUNT OF BLOOD DURING THE SURGICAL OPERATION AND

  Patient problems: Blood Loss; Death; Perforation of Vessels

  MAUDE report 8247452 ↗