Valiant Navion™ VNMC3434C223TU (UDI 00763000260828)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000260828), received between Jul 15, 2020 and Jan 23, 2023 — classified as 4 injuries.

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.

• InjuryJan 23, 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 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 ONE MONTH POST THE INDEX PROCEDURE DEMONSTRATED AORTIC ENLARGEMENT. REINTERVENTION WAS COMPLETED WHERE AN ADDITIONAL VALIANT NAVION GRAFT WAS IMPLANTED. 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

  MAUDE report 16223076 ↗
• InjuryFeb 24, 2022Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. IT WAS REPORTED FROM A CT TAKEN UNDER A MONTH LATER THAT THE THERE WAS EVIDENCE OF PERFUSION FROM PROXIMAL ENTRY TEAR, A TYPE IA ENDOLEAK. THE MAXIMUM AORTIC DIAMETER MEASURED 60MM. NO RELATED ASSESSMENT HAS BEEN PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 13590534 ↗
• InjuryJan 21, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZE RUPTURED THORACIC AORTIC ANEURYSM. IT WAS REPORTED 5 DAYS LATER, THE PATIENT WAS EXPERIENCING RECURRENT BACK PAIN. A CT SCAN WAS PERFORMED WHICH SHOWED A POSSIBLE IA ENDOLEAK OR IIIB ENDOLEAK. THE PATIENT WAS BROUGHT TO OR AND ALTHOUGH AN ENDOLEAK COULD NOT BE ANGIOGRAPHICALLY RECONFIRMED, THE STENT GRAFT WAS RELINED WITH ANOTHER VALIANT NAVION DEVICE. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 11207216 ↗
• InjuryJul 15, 2020Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED FOR A 30-40 MM THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT APPROXIMATELY 3 DAYS LATER, A CT WAS PERFORMED AND A TYPE IA ENDOLEAK WAS OBSERVED. BALLOONING WAS THEN PERFORMED PROXIMALLY WHICH RESOLVED THE ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS THAT THE PIGTAIL CATHETER DURING THE INDEX PROCEDURE WAS NOT PLACED IN THE PROXIMAL ASPECT OF THE GRAFT AND AS A RESULT THE LEAK WAS NOT SEEN THEN. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 10275354 ↗