Valiant Navion™ VNMF4646C223TURecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000100810), received between Oct 14, 2021 and Jun 17, 2025 — classified as 1 death, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2025Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  TWO VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED APPROX. 5 YEARS, 11 MONTHS POST INDEX PROCEDURE, A SECONDARY PROCEDURE WAS PERFORMED. THIS INVOLVED DEBRANCHING OF THE LEFT SUBCLAVIAN AND VERTEBRAL ARTERY WITH TRANSPOSITION. THE PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF 500CC BUT REMAINED STABLE AND DID NOT REQUIRE TRANSFUSION. GOOD FLOW WAS ACHIEVED IN THE SUBCLAVIAN, CAROTID AND LEFT VERTEBRAL ARTERIES FOLLOWING THE TRANSPOSITION. TWO DAYS LATER, A FOLLOW UP PROCEDURE WAS CONDUCTED ADDRESS PROXIMAL DEGENERATION / GRAFT MIGRATION WHICH HAD RESULTED IN A TYPE IA ENDOLEAK. A PROXIMAL EXTENSION WAS PLACED AS PART OF AN ENDOVASCULAR AORTIC REPAIR. ADDITIONAL DISTAL COMPONENTS WERE PLACED TO TREAT EXPANDING PARA VISCERAL AND DISTAL DESCENDING OF TAA, WHICH DEVELOPED ABOVE THE PREVIOUSLY PLACED ABDOMINAL FENESTRATED GRAFT. THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS NOTED TO BE DIFFUSELY DISEASED WITH TWO REGIONS OF SEVERE STENOSIS. DURING THIS PROCEDURE, THREE NON-MEDTRONIC GRAFTS WERE SUCCESSFULLY IMPLANTED IN THE THORACIC AORTA, ACHIEVING EXCELLENT FLOW THROUGH THE GRAFTS AND EFFECTIVE COVERAGE OF THE DISEASED AORTA. THE PRO

  Patient problems: Aneurysm expansion; Insufficient Information

  MAUDE report 22227031 ↗
• MalfunctionFeb 9, 2024Leak/Splash; Leak/Splash

  TWO VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A TAA. IT WAS REPORTED THAT CORELAB REVIEW OF NON CONTRAST CT IMAGES FROM (B)(6) 2023 SHOWED A TYPE III ENDOLEAK (SUB TYPE NOT SPECIFIED) ALONG THE INFERIOR ASPECT OF THE AORTIC ARCH. SPECIFICALLY, "INTERVAL DEVELOPMENT OF CONTRAST DEMONSTRATED BENEATH/INFERIOR TO THE STENT GRAFT ALONG THE AORTIC ARCH MEASURING 4.1 CM (AP) X 1.8 CM (TV) X 1.3 CM (CC). THE CAUSE OF THE TYPE III ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676201 ↗
• DeathNov 24, 2021Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE PATIENT IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RUPTURE AND ENDOLEAK POST IMPLANTATION. IT WAS REPORTED THE PATIENT EXPIRED APPROXIMATELY 14 MONTHS POST THE INDEX PROCEDURE. AS PER THE PHYSICIAN, THE CAUSE OF THE RUPTURE, ENDOLEAK AND DEATH CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 12867331 ↗
• InjuryOct 14, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED  FOR THE  ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. IT WAS REPORTED ON AN UNKNOWN DATE AROUND 2 YEARS LATER, A REINTERVENTION PROCEDURE WAS COMPLETED. THERE IS NO INFORMATION AT THIS TIME ON WHAT LED TO THE INTERVENTION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 12631795 ↗