Valiant Navion™ VNMC2525C180TU (UDI 00763000100940)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000100940), received between Mar 11, 2022 and Jan 23, 2023 — classified as 1 death, 3 injuries.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Feb 12, 2021Class IOpen, Classified

   Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.

   Z-1201-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• DeathJan 23, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION ON THE (B)(6) 2020. ADDITIONAL NON MDT DEVICES WERE ALSO IMPLANTED (ADDITIONAL DEVICES DISTAL TO NAVION: RIGHT ILIAC 25X25X180, RIGHT ILIAC 8X59, INTO SMA 7X22). IT WAS REPORTED ON THE DAY OF THE INDEX PROCEDURE A CT OBSERVED AN UNKNOWN TYPE ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. IT WAS NOTED THE PATIENT EXPIRED ON (B)(6) 2020. THIS WAS CONFIRMED AS NON AORTIC RELATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223713 ↗
• InjuryNov 17, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 81MM THORACIC ANEURYSM THAT HAD PRERUPTURED WITH A DISSECTION. THE PATIENT HAD 3 EXISTING VALIANT NAVION GRAFTS IMPLANTED 6 MONTHS PREVIOUSLY DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED 2 DAYS POST THE PROCEDURE, CT IDENTIFIED A TYPE I ENDOLEAK INVOLVING THE DISTAL ASPECT OF THE ENDOGRAFT WITHIN THE S UPRARENAL ABDOMINAL AORTA. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 15814042 ↗
• InjuryMay 18, 2022Material Deformation; Material Deformation

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED TO REPAIR AN IVC ON (B)(6) 2019. THE NAVION STENTS WERE PLACED OFF LABEL IN THE INFERIOR VENA CAVA. IT WAS REPORTED THAT ON THE (B)(6) 2019, THE STENT GRAFTS WERE RELINED WITH A NON MDT STENT GRAFT DUE TO A COLLAPSED STENT. THE CAUSE OF THE STENT COLLAPSE WAS NOT PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 14433135 ↗
• InjuryMar 11, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM ON (B)(6) 2018. IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE FOLLOW UP CT IDENTIFIED AN IN STENT DISSECTION AND A TYPE II ENDOLEAK. THE PATIENT HAD NO KNOWN SYMPTOMS OR COMPLICATIONS. AN INTERVENTION WAS PERFORMED ON (B)(6) 2021 WHERE 3 NON MDT STENT GRAFTS WERE IMPLANTED TO RELINE.  PER THE PHYSICIAN THE CAUSE OF THE DISSECTION WAS IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Vascular Dissection

  MAUDE report 13734287 ↗