Valiant Navion™ VNMC3737C90TU (UDI 00763000260842)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000260842), received between Feb 15, 2022 and Sep 18, 2025 — classified as 3 deaths, 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• DeathSep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZED TAA AND DISSECTION. IT WAS REPORTED THAT CORELAB HAVE REVIEWED CT IMAGING AND HAVE IDENTIFIED A TYPE IA ENDOLEAK ON THE STENT GRAFT WITH SN (B)(6). NO FRACTURE, STENT RING ENLARGEMENT/MIGRATION WERE NOTED. THE MAXIMUM AORTIC DIAMETER WAS 54.6MM. IT WAS REPORTED THE PATIENT PRESENTED WITH A CONTAINED RUPTURE OF TYPE A AORTIC DISSECTION APPROXIMATELY 4 YEARS AND 8 MONTHS AFTER THE INDEX PROCEDURE. THE PATIENT UNDERWENT SURGERY BUT SUFFERED A PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST IN THE INTENSE CARE UNIT (ICU). FOLLOWING THE ARREST, COMFORT CARE WAS INITIATED AT THE FAMILY'S REQUEST. THE PATIENT EXPIRED ON THE SAME DATE. THE CAUSE OF DEATH WAS ASSESSED AS AORTIC-RELATED DUE TO THE DISSECTION. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 23081689 ↗
• InjurySep 25, 2023Adverse 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 ULCER . IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED THORACIC PAU. A PROXIMAL EXTENSION WAS IMPLANTED SUCCESSFULLY AS T REATMENT.  PER THE PHYSICIAN THE CAUSE OF THE RUPTURE WAS ANATOMY AND DISEASE PROGRESSION.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 17806112 ↗
• MalfunctionMay 10, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION . IT IS NOTED THIS PATIENT HAS ADDITIONAL DEVICES - (LEFT CAROTID SUBCLAVIAN BYPASS 8MM NON MDT GRAFT AND LSCA EMBOLIZATION COILS. IT WAS REPORTED POST THE INDEX PROCEDURE A TYPE IB ENDOELAK WAS OBSERVED. FOLLOW UP CT ABOUT 13 MONTHS LATER DEMONSTRATED AORTIC ENL ARGEMENT. REINTERVENTION WAS COMPLETED WHERE AN ADDITIONAL VALIANT NAVION GRAFT WAS IMPLANTED. IT WAS REPORTED THE PATIENT UNDERWENT ANOTHER CT CHEST/ABDOMEN/PELVIS WITH/WITHOUT CONTRAST OVER TWO YEARS POST THE RE INTERVENTION WHICH SHOWED PERSISTENT TYPE IB ENDOLEAK AND AORTIC ENLARGEMENT. BOTH FINDINGS WHICH WERE FIRST NOTED . IT WAS CONFIRMED THE STENT GRAFT THAT CONTAINED THE INITIAL IB ENDOLEAK WASVNMC3434C182TU (B)(6) . NO CAUSE OF THE IB ENDOLEAK WAS PROVIDED BY THE PHYSICIAN. IT WAS CONFIRMED THE IB ENDOLEAK SEEN ON CT LAST MONTH IS PRESENT ON THE DISTAL DEVICE VNMC3737C90TU (B)(6) WHICH HAS BEEN IMPLANTED AS INTERVENTION FOR THE PREVIOUS IB ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE TYPE IB ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 16900966 ↗
• DeathNov 18, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA.  IT WAS REPORTED ON 28 DAYS LATER, A CT IDENTIFIED AN UNDETERMINED ENDOLEAK. THE PATIENT DIED ON THE SAME DATE POSSIBLY DUE TO AN AORTIC RUPTURE.  PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNKNOWN.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Hematoma; Rupture

  MAUDE report 15825320 ↗
• MalfunctionNov 15, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR TREATMENT.  IT WAS REPORTED THAT THROUGH A CORELAB REVIEW, OF A CT TAKEN 15 MONTHS POST INDEX PROCEDURE, A TYPE IB ENDOLEAK WAS NOTED ON STENT G RAFT V29989341. NO FRACTURE, STENT RING ENLARGEMENT OR STENT RING MIGRATION WERE OBSERVED.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15796392 ↗
• DeathFeb 16, 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 THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC FUSIFORM ANEURYSM. IT WAS REPORTED APPROXIMATELY 2 MONTHS POST THE INDEX PROCEDURE FOLLOW-UP CT IDENTIFIED A TYPE II ENDOLEAK. THE PATIENT WAS HEMODYNAMICALLY UNSTABLE AND WAS ADMITTED WITH A POSSIBLE GRAFT INFECTION AND ANEMIA. AN MRA DEMONSTRATED AN INCREASED SIZE OF THE ANEURYSM SAC AND A TYPE IIIA ENDOLEAK AT THE SMA . THE IMAGE SHOWED A DISCONNECTION FROM THE MANIFOLD. THE INFECTION LED TO SEPSIS AND MULTI -ORGAN FAILURE AND EVENTUAL DEATH APPROXIMATELY 11 WEEKS POST THE INDEX PROCEDURE. AS PER THE PHYSICIAN THE CAUSE OF THE TYPE II AND IIIA ENDOLEAK ARE UNDETERMINED. THE CAUSE OF DEATH WAS DUE TO HEMODYNAMIC INSTABILITY WITH SEPSIS LEADING TO MULTI-ORGAN FAILURE AND DEATH. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Anemia; Sepsis; Unspecified Infection

  MAUDE report 13542321 ↗
• MalfunctionFeb 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 DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC ANEURYSM. TWO FURTHER VALIANT NAVION STENT GRAFTS WERE IMPLANTED MONTHS LATER. IT WAS REPORTED THAT THE PATIENT RETURNED FOR A FOLLOW-UP CT FIVE MONTHS LATER AND A TYPE IA ENDOLEAK WAS OBSERVED. ANOTHER CT WAS TAKEN AND THE TYPE IA ENDOLEAK WAS STILL PRESENT.  NO CAUSE AS PER THE PHYSICIAN WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13533635 ↗