Valiant Navion™ VNMC3131C223TU (UDI 00763000100995)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000100995), received between Jun 19, 2020 and Jun 7, 2024 — classified as 1 death, 2 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathJun 7, 2024Adverse 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 THORACIC AORTIC DISSECTION. IT WAS REPORTED APPROXIMATLEY 3 YEARS POST THE INDEX PROCEDURE, THE PATIENT SUFFERED A LIFE-THREATENING ILLNESS OR INJURY AND EXPIRED. IT WAS NOTED THAT THE PATIENT MISSED FOLLOW UP VISITS AND THE DEATH WAS DISCOVERED ON AN ONLINE SEARCH. THE SITE ASSESSED THE DEATH AS UNLIKELY RELATED TO THE STUDY DEVICE, PROCEDURE AND UNDERLYING DISSECTION. THE MEDICAL MONITOR ASSESSED THE DEATH AS UNRELATED TO THE STUDY DEVICE, PROCEDURE AND UNDERLYING DISSECTION.

  Patient problems: Insufficient Information

  MAUDE report 19483794 ↗
• InjuryApr 17, 2023Fracture; Leak/Splash; Detachment of Device or Device Component; Fracture; Leak/Splash; Detachment of Device or Device Component

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE TREATMENT ON A TAA. IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE, FOLLOW-UP CT SHOWED A TYPE IIIB ENDOLEAK IN THE NAVION STENT GRAFT. THE STENT GRAFT WAS RELINED USING A VALIANT CAPTIVIA STENT GRAFT AND THE ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS STENT GRAFT FAILURE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 16750398 ↗
• MalfunctionJan 24, 2023Leak/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 THORACIC AORTIC DISSECTION.  IT WAS REPORTED ON THE DATE OF THE CT A TYPE IB ENDOLEAK AND AORTIC ENLARGEMENT WAS NOTED.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 16231731 ↗
• InjuryJun 19, 2020Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AORTIC INTRAMURAL HEMATOMA (IMH). IT WAS REPORTED THAT ON THE DATE OF THE CT, JUST UNDER A YEAR POST THE INDEX PROCEDURE, A TYPE IA ENDOLEAK WAS OBSERVED WITH AORTIC DILATION. IT WAS NOTED THERE WAS 25MM OF PROXIMAL SEAL ZONE AVAILABLE TO EXTEND COVERAGE TO THE LEFT COMMON CAROTID. INTERVENTION WAS PERFORMED ON THE SAME DATE, AND A VNMF 37X37X174MM STENT GRAFT WAS IMPLANTED AS TREATMENT IN A GOOD PROXIMAL POSITION TO THE LEFT COMMON CAROTID ARTERY. FINAL ANGIOGRAM SHOWED THE ENDOLEAK HAD RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND NOTED THERE TO BE SIGNIFICANT AORTIC REMODELING. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 10173299 ↗