Valiant Navion™ VNMC4040C95TU (UDI 00763000101091)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000101091), received between Jun 19, 2020 and Apr 7, 2026 — classified as 3 deaths, 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2026Fracture; Leak/Splash

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 297MM THORACIC DISSECTION. IT WAS REPORTED ON AN UNKNOWN DATE, A POSSIBLE TYPE III ENDOLEAK IN THE DISTAL AREA OF THE GRAFT, STENT FRACTURE AND DISEASE PROGRESSION WERE IDENTIFIED. INTERVENTION WAS COMPLETED WHERE A NON MDT STENT WAS IMPLANTED HOWEVER THE ENDOLEAK REMAINED. PER THE PHYSICIAN THE CAUSE IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 24798634 ↗
• MalfunctionMar 20, 2024Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT (VNMC4040C95TU) WAS IMPLANTED DURING THE RE-INTERVENTION OF A THORACIC AORTIC REPAIR. THE PATIENT HAD 4 EXISTING VALIANT CAPTIVIA STENT GRAFTS IMPLANTED 3 MONTHS APART APPROXIMATELY 2 YEARS PREVIOUS. IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING TAKEN APPROXIMATELY 5 MONTHS POST THE IMPLANT OF THE NAVION GRAFT SHOWED A NEW UNDETERMINED ENDOLEAK. THE MAX AORTIC DIAMETER WAS NOTED AS 72.9MM. THE IMAGING WAS NA FOR AORTIC ENLARGEMENT. NO STENT FRACTURE, STENT RING ENLARGEMENT OR STENT RING MIGRATION WAS OBSERVED. THE CAUSE OF THE ENDOLEAK IS UNDETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941247 ↗
• DeathMay 29, 2023Leak/Splash; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS (X2) WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM/DISSECTION. AN ENDURANT IIS STENT GRAFT SYSTEMA AND 3 ADDITIONAL VALIANT NAVION STENTS WERE IMPLANTED 2 MONTHS POST THE INDEX PROCEDURE. AN ADDITIONAL ENDURANT LIMB WAS IMPLANTED 21 MONTHS POST THE INDEX PROCEDURE. CORE LAB REVIEW OF CT IMAGING FROM (B)(6) 2020 IDENTIFIED A NEW TYPE II ENDOLEAK ASSOCIATED WITH THE NAVION DEVICES VNMC4040C95TU ((B)(6)) AND VNMC4646C55TU ((B)(6)). THE MAX AORTIC DIAMETER WAS NOTED AS 61.5MM. THE IMAGING WAS NOTED AS NE FOR FRACTURES ON VNMC4646C55TU ((B)(6)) DUE TO DEVICE OVERLAPS. IT WAS REPORTED THE PATIENT EXPIRED ON AN UNKNOWN DATE. THE CAUSE OF DEATH WAS NOT PROVIDED.

  Patient problems: Aneurysm; Insufficient Information

  MAUDE report 17016949 ↗
• DeathJul 15, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AORTIC INTRAMURAL HEMATOMA (IMH). IT WAS REPORTED THAT ON ROUTINE FOLLOW-UP APPROXIMATELY 10 MONTHS POST THE INDEX PROCEDURE, A CT PERFORMED SHOWED THAT GRAFT SEPARATION HAD OCCURRED BETWEEN THE (B)(4) COMPONENTS. INTERVENTION WAS COMPLETED WHERE THE PHYSICIAN PLACED ANOTHER VALIANT NAVION STENT GRAFT ((B)(4)) TO RECONNECT THE GRAFTS. THE PATIENT WAS DISCHARGED TWO DAYS POST INTERVENTION. IT WAS REPORTED THE PATIENT EXPIRED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE DUE TO CARDIAC ARREST. THE PATIENT HAD IMAGING DONE THAT REVEALED STENT DISSECTION AND THROMBUS. AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IIIA ENDOLEAK AND STENT DISSECTION, THROMBUS AND DEATH CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Cardiac Arrest; Insufficient Information; Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 15026011 ↗
• MalfunctionMar 28, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT CORELAB REVIEWED CT IMAGING DATED ABOUT A YEAR LATER, AND A TYPE IB ENDOLEAK WAS NOTED. NO FRACTURE, STENT RING ENLARGEMENT WERE SEEN. THE CAUSE OF THE TYPE IB ENDOLEAK WAS NOT PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE NOTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13927949 ↗
• MalfunctionJan 4, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC ANEURYSM OF AN UNKNOWN SIZE. IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE FOLLOW-UP CT SHOWED THE ANEURYSM EXTRANEOUS TO THE GRAFT APPEARS THROMBOSED. THERE WAS A SMALL AMOUNT OF CONTRAST OPACIFICATION WITHIN THE ANEURYSM EXTRANEOUS TO THE GRAFT SUGGESTING A TYPE I ENDOLEAK AT THE DISTAL ASPECT OF THE THORACIC GRAFT. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MO NITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13150894 ↗
• InjuryOct 1, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 85MM THORACIC AORTIC ANEURYSM.  IT WAS REPORTED APPROXIMATELY 6 MONTHS POST THE INDEX PROCEDURE, FOLLOW CT SHOWED A PROBABLE TYPE III ENDOLEAK. INTERVENTION WAS PERFORMED 2 DAYS LATER, WHERE THE STENT GRAFT WAS RELINED, THIS RESOLVED THE EVENT.  AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS A NAVION FAILURE.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12559891 ↗
• DeathJul 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED 38 MM THORACIC AORTIC ANEURYSM WITH INTRAMURAL HEMATOMA. IT WAS NOTED THAT THERE WAS 3X90-180 DEGREE TURNS IN THE EXTREMELY ANGULATED DESCENDING AORTA. IT WAS NOTED THAT SOME OTHER VESSELS WERE TORTUOUS AND CALCIFIED. IT WAS REPORTED THAT THE INDEX PROCEDURE WAS COMPLETED WITHOUT ISSUES AFTER USE OF MULTIPLE DEVICES TO REPAIR THE PATIENTS ANEURYSM. IT WAS REPORTED THAT THE DAY AFTER THE INDEX PROCEDURE, THE PHYSICIAN STATED THAT THERE WAS AN ENTRY TEAR OF AN RTAD ON THE LESSER CURVE NEAR THE PROXIMAL EDGE OF THE PROXIMAL GRAFT. THE PHYSICIAN NOTED THAT THE PATIENT WAS HIGH RISK FOR RTAD DUE TO THE IMH IN THE ARCH, THE CHALLENGING ANATOMY AND THE DILATED ASCENDING AORTA. IT WAS REPORTED THAT THE PATIENT DEVELOPED CEREBRAL MALPERFUSION AS A RESULT OF THE RTAD. THE PATIENT'S FAMILY WITHDREW LIFE SUPPORT TWO DAYS LATER AND THE PATIENT DIED. THE CAUSE OF THE RTAD EVENT WAS ANATOMY RELATED AS PER THE PHYSICIAN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death; Vascular Dissection

  MAUDE report 10217889 ↗
• InjuryJun 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 70MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THERE WERE NO ISSUES ENCOUNTERED DURING THIS PROCEDURE. IN ADDITION, THE DAY PRIOR TO THE TEVAR PROCEDURE, THE PATIENT UNDERWENT A CAROTID SUBCLAVIAN BYPASS AS PART OF THE TREATMENT PLAN FOR THE THORACIC AORTIC ANEURYSM. THE FOLLOWING DAY AFTER THE INDEX PROCEDURE, IT WAS REPORTED THE PATIENT SUFFERED A STOKE AND HAD A CEREBRAL INFRACT WHICH WAS RELATED TO THE PROCEDURE. IT WAS THEN DECIDED TO WITHDRAW CARE AND THE PATIENT WAS THEN RECEIVING PALLIATIVE CARE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Stroke/CVA

  MAUDE report 10173950 ↗