Valiant Navion™ VNMC4646C218TU (UDI 00763000101190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000101190), received between Feb 22, 2019 and Apr 1, 2025 — classified as 1 death, 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2025Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING FROM APPROX. 48 MONTHS POST INDEX PROCEDURE, NOTED A NEW STENT RING ENLARGEMENT OF + 1.5MM WAS NOTED ON RING 4 OF (B)(6) AND +1.6MM ON RING 6 OF(B)(6). A NEW TYPE IIIB ENDOLEAK OBSERVED ON STENT GRAFT (B)(6). NO FRACTURE OR STENT RING MIGRATION WERE NOTED. THE MAXIMUM AORTIC DIAMETER MEASURED 58.5MM. NO AORTIC ENLARGEMENT WAS REPORTED. NO STENT RING MIGRATION OR STENT FRACTURES WERE OBSERVED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm expansion; No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 21738599 ↗
• MalfunctionMar 8, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A RUPTURED THORACIC AORTIC ANEURYSM .  IT WAS REPORTED A CT SCAN REVEALED A POSSIBLE TYPE I ENDOLEAK.  AS PER THE PHYSICIAN THE CAUSE CANNOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13688639 ↗
• InjuryApr 23, 2021Fracture; Leak/Splash; Material Deformation; Fracture; Leak/Splash; Material Deformation

  VALIANT CAPTIVIA AND NAVION STENT GRAFTS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 67.8MM X 78.5MM THORACIC ANEURYSM. APPROX. 1 YEAR 8 MONTHS POST INDEX, AN ADDITIONAL 2 VALIANT NAVION DEVICES WERE IMPLANTED FOR AN UNKNOWN PROCEDURE IT WAS REPORTED THE CORE LAB OBSERVED THE FOLLOWING AFTER ANALYSIS OF THE 12M, INTERIM <(>&<)> 24M CTS: TYPE IIIB ENDOLEAK OF V07404460 VALIANT CAPTIVIA DEVICE <(>&<)> TYPE IIIA ENDOLEAK BETWEEN V08146953 AND V08097833 NAVION DEVICES. MOREOVER, 7 STENT FRACTURES (6 FRACTURES IN MOST DISTAL STENT AND 1 FRACTURE IN SECOND MOST DISTAL STENT) <(>&<)> STENT ENLARGEMENT IN SECOND STENT RING OF V08097833 NAVION DEVICE. NO CAUSE OF THE EVENT WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 11714961 ↗
• MalfunctionSep 11, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A VALIANT NAVION STENT GRAFT WAS PLANNED TO BE IMPLANTED IN A PATIENT FOR A THORACIC AORTIC ENDOVASCULAR REPAIR. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE DEVICE WAS ADVANCED INTO THE PROXIMAL DESCENDING THORACIC AORTA SUCCESSFULLY. HOWEVER, WITH RELEASE OF THE PROXIMAL CONSTRAINING MECHANISM OF THE COVERED SEAL PORTION OF THE DEVICE THE DEVICE WAS NOT SUCCESSFULLY RELEASED. THEREFORE, THE BACK PORTION OF THE DELIVERY SYSTEM WAS MANUALLY EXPOSED AND WITH MULTIPLE MOVEMENTS FORWARD AND BACKWARD OF THE INNER CANNULA OF THE DELIVERY SYSTEM ULTIMATELY THE PROXIMAL COVERED SEAL PORTION OF THE DEVICE WAS ABLE TO BE SUCCESSFULLY DEPLOYED. THE ENTIRE DELIVERY SYSTEM WAS THEN SUCCESSFULLY REMOVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8988811 ↗
• MalfunctionAug 27, 2019Mechanical Problem

  DURING TEVAR PROCEDURE MEDTRONIC VALIANT NAVION DEVICE MALFUNCTIONED DURING DEPLOYMENT. PORTION OF HANDLE DISASSEMBLED, DEPLOYMENT WAS SUCCESSFUL. FROM THE OPERATIVE NOTE: NEXT, THE PROXIMAL DEVICE A MEDTRONIC NEVI ON A 46 X 46 X 218 MM, WAS ADVANCED FROM THE LEFT FEMORAL ACCESS OVER THE DOUBLE CURVE LUNDERQUIST WIRE INTO THE PROXIMAL DESCENDING THORACIC AORTA AND ON SHEATH SUCCESSFULLY. HOWEVER, WITH RELEASE OF THE PROXIMAL CONSTRAINING MECHANISM OF THE COVERED SEAL PORTION OF THE DEVICE THE DEVICE WAS NOT SUCCESSFULLY RELEASED. THEREFORE, THE BACK PORTION OF THE DELIVERY SYSTEM WAS MANUALLY EXPOSED AND WITH MULTIPLE MOVEMENTS FORWARD AND BACKWARD OF THE INNER CANNULA OF THE DELIVERY SYSTEM ULTIMATELY THE PROXIMAL COVERED SEAL PORTION OF THE DEVICE WAS ABLE TO BE SUCCESSFULLY DEPLOYED. THE ENTIRE DELIVERY SYSTEM WAS THEN SUCCESSFULLY REMOVED OVER THE LUNDERQUIST WIRE AND A 20 FRENCH SHEATH WAS ADVANCED OVER THE LUNDERQUIST WIRE INTO THE LEFT COMMON FEMORAL ARTERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8935021 ↗
• DeathFeb 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 370 MM THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT TWO DAYS POST THE INDEX PROCEDURE THE PATIENT HAD A SUDDEN CARDIAC ARREST AND DIED. THE CAUSE OF THE CARDIAC ARREST IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT HAS EXPIRED.

  Patient problems: Cardiac Arrest; Death

  MAUDE report 8361601 ↗