Valiant Navion™ VNMC4646C218TU (UDI 00763000260989)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000260989), received between Dec 15, 2020 and Mar 7, 2022 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENTS OF A THORACIC AORTIC DISSECTION . IT WAS REPORTED THE PATIENT RETURNED FOR FOLLOW-UP AND CT IMAGING REVEALED THE PRESENCE OF A TYPE IA ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK CANNOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENTS STATUS IS UNKNOWN. THE PATIENT WAS REPORTEDLY LOST TO FOLLOW-UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13685226 ↗
• DeathDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 65.4MM RUPTURED THORACIC AORTIC ANEURYSM. IT WAS REPORTED OVER 7 YEARS LATER, THE PATIENT PRESENTED TO ER. A CT REVEALED AN INCREASE IN ANEURYSM SIZE LIKELY DUE TO A TYPE III ENDOLEAK. TWO DAYS LATER AN URGENT TEVAR PROCEDURE WAS PERFORMED. THE PHYSICIAN STATED IT WAS BELIEVED THE BARE STENT OF THE VAMF3636C200TJ HAD ERODED THROUGH THE FABRIC OF THE VAMF4444C200TU STENT GRAFT CAUSING THE SUSPECTED TYPE III ENDOLEAK. DURING THE INTERVENTION A VALIANT NAVION WAS IMPLANTED TO COVER THE TEAR AND ENDOLEAK WAS RESOLVED FOLLOWING ITS DEPLOYMENT. THE PATIENT SURVIVED THE PROCEDURE, BUT POST-OPERATIVELY DEVELOPED A CLOT IN THE RIGHT LUNG WHICH A TEST TUBE WAS UNABLE TO CLEAR. THE PATIENT BECAME ACIDOTIC AND EXPIRED ON AN UNKNOWN DATE. IT WAS SAID THE PHYSICIAN IN CONSULTATION WITH THE PATIENTS FAMILY DECIDED TO FORGO ROUTINE FOLLOW-UP SCANS FOR THIS PATIENT 3 YEARS PREVIOUSLY AS THERE WAS NO FURTHER ENDOVASCULAR TESTAMENT OPTIONS AVAILABLE AND IT WAS KNOWN THE PATIENT WAS UNLIKELY TO SURVIVE AN OPEN REPAIR. AS PER THE PHYSICIAN THE CAUSE OF THE IIIB ENDOLEAK WAS THE BARE STENT OF THE DISTAL DEVICE ERODING THE FABR

  Patient problems: Embolism/Embolus; Rupture

  MAUDE report 11018178 ↗
• MalfunctionDec 15, 2020Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 46MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, DUE TO THE EXTREME TORTUOSITY OF THE VESSELS THERE WAS DIFFICULTY DEPLOYING THE DEVICE AND THE DELIVERY SYSTEM BEGAN TO COME APART AS A RESULT. THE STENT GRAFT WAS ABLE TO BE SUCCESSFULLY IMPLANTED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND EXTREME TORTUOSITY. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11010686 ↗