Valiant Navion™ VNMC2828C90TU (UDI 00763000100957)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000100957), received between Nov 9, 2021 and Sep 23, 2024 — classified as 2 deaths, 2 injuries, 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.

• MalfunctionSep 23, 2024Leak/Splash; Leak/Splash

  TWO VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. IT WAS REPORTED COREL LAB REVIEW OF CT IMAGING FROM APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE IDENTIFIED A NEW TYPE IA ENDOLEAK IN VNMC2828C90TU S/N (B)(6). NO FRACTURE, STENT RING ENLARGEMENT, STENT RING MIGRATION OR STENT RING DETACHMENT WAS OBSERVED. THE MAX AORTIC DIAMETER WAS 46.8MM. NO AORTIC ENLARGEMENT WAS OBSERVED. THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279702 ↗
• MalfunctionJun 26, 2024Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN TAA. THE PATIENT HAD 4 EXISTING VALIANT CAPTIVIA GRAFTS IMPLANTED 6 YEARS PREVIOUS. IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING FROM APPROXIMATELY 3 YEARS POST THE NAVION IMPLANT, SHOWED A IB ENDOLEAK ON VNMC2828C90TU ((B)(6)). NO STENT FRACTURE, STENT RING ENLARGEMENT OR STENT RING MIGRATION WAS OBSERVED. THE MAXIMUM AORTIC DIAMETER WAS NOTED AS 59.5MM. DEVICE ORDER ON IMAGING WAS NOT CONFIRMED. A NON NAVION TYPE IA ENDOLEAK WAS OBSERVED PROXIMALLY. THE CAUSE OF THE ENDOEAKS ARE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19615579 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION THORACIC STENT GRAFTS WERE IMPLANTED FOR THE TREATMENT OF  AN UNKNOWN SIZE  ANEURYSM ON (B)(6) 2020. IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE, ON (B)(6) 2021 SHOWED AORTIC ENLARGEMENT (42MM COMPARED TO 39MM PREVIOUS). A SECONDARY PROCEDURE TO REPAIR THE DILATED DESCENDING AORTA WHERE A NON MDT GRAFT AND A THORACIC ABDOMINAL GRAFT WAS COMPLETED. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE, CT SHOWED AN INCREASE IN AORTIC DIMENSION IN DISTAL ARCH AND DESCENDING THORACIC AORTA, WHICH NOW MEASURES 47MM, WAS NOTED. CORELAB REVIEW OF CT IMAGING FROM ON (B)(6) 2022 IDENTIFIED A TYPE IA ENDOLEAK INVOLVING VNMC3434C90TU (V29531128). THERE WAS NO STENT FRACTURE, STENT RING ENLARGEMENT OR STENT RING DETACHMENT OBSERVED. NO CAUSE OF ENDOLEAK PROVIDED. THE CAUSE OF THE EVENT IS UNKNOWN.  NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm

  MAUDE report 16291227 ↗
• InjuryJan 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A LEFT ABERRANT SUBCLAVIAN ARTERY. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE FOLLOW UP CT SHOWED COMPLETE OCCLUSION OF THE STENTED RIGHT EXTERNAL ILIAC AND COMMON FEMORAL ARTERIES. PER THE PHYSICIAN THE CAUSE OF THE OCCLUSION WAS DUE TO FURTHER PROGRESSION OF PAD. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16173032 ↗
• MalfunctionJan 13, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFT WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA.  IT WAS REPORTED ON THE DATE OF THE CT, AN UNDETERMINED SMALL TYPE I ENDOLEAK WAS 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 16155727 ↗
• DeathNov 18, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A DISSECTION.  IT WAS REPORTED ABOUT 18 MONTHS LATER, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH HEMOPTYSIS. A CT PERFORMED REVEALED A LARGE PSEUDOANEURYSM AND TYPE I ENDOLEAK.  THE PATIENT THEN EXPIRED. APLASTIC ANEMIA WAS ALSO NOTED.  THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Anemia; Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding; Pneumothorax; Pseudoaneurysm; Respiratory Failure; Rupture; Thrombocytopenia; Unspecified Infection; Vascular Dissection

  MAUDE report 15825603 ↗
• DeathNov 9, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED DURING AN UNKNOWN THORACIC ENDOVASCULAR PROCEDURE. IT WAS REPORTED 15 DAYS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY. A CT SCAN PERFORMED SHOWED EXTRAVASATION FROM THE GRAFT AND THE PATIENT HAD HEMATEMESIS. IT WAS REPORTED THAT THE PATIENT EXPIRED ON THE DAY THEY PRESENTED. AS PER THE PHYSICIAN THE CAUSE OF HEMATEMESIS AND EXTRAVASATION IS UNDETERMINED. THE CAUSE OF DEATH WAS A RESULT OF  HEMATEMESIS AND EXTRAVASATION. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Abdominal Pain; Fistula; Hematemesis; Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 12777849 ↗