Valiant Navion™ VNMF4646C62TU (UDI 00763000100780)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000100780), received between Apr 24, 2019 and Jun 17, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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 18, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION WAS IMPLANTED FOR THE TREATMENT OF A FUSIFORM ANEURYSM OF AN UNKNOWN SIZE. IT WAS REPORTED THE PATIENT RETURNED FOR A FOLLOW-UP CT APPROXIMATELY 1 YEAR LATER AND A TYPE IA ENDOLEAK AND AORTIC ENLARGEMENT WERE IDENTIFIED. THE PATIENT EXPIRED ON THE FOLLOWING DAY . NO CAUSE OF THE ENDOLEAK AS PER THE PHYSICIAN WAS PROVIDED.  AS PER THE PHYSICIAN THE CAUSE OF DEATH WAS NOT AORTIC-RELATED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14729957 ↗
• InjuryJan 16, 2020Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 6 WEEKS LATER WHEN THE PATIENT RETURNED FOR FOLLOW-UP A CT SHOWED A TYPE IA ENDOLEAK. A SECONDARY PROCEDURE WAS CARRIED OUT ON THE SAME DATE AND A VALIANT NAVION (VNMF4646C62TU) WAS PLACED BELOW THE RENAL ARTERY ALONG WITH APTUSENDOANCHORS. ON FINAL ANGIOGRAM THE ENDOLEAK HAD RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9595479 ↗
• MalfunctionApr 24, 2019Malposition of Device; Malposition of Device

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 53MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS NOTED THAT THE PATIENT HAD PREVIOUSLY HAD A GORE STENT GRAFT IMPLANTED WHICH HAD MIGRATED DUE TO DISEASE PROGRESSION. IT WAS OBSERVED THAT THE AORTA MEASURED 41MM JUST BELOW THE RENALS. MILD VESSEL CALCIFICATION WAS NOTED. IT WAS REPORTED THAT DURING DEPLOYMENT OF THE CUFF, THE GRAFT MIGRATED PROXIMALLY ABOUT 2CM COVERING BOTH RENAL ARTERIES. AT THIS POINT THE BARE STENTS HAD NOT BEEN DEPLOYED AND SO THE GRAFT WAS ABLE TO BE PULLED DOWN TO BELOW THE RENALS TO ALLOW RENAL PERFUSION. A SECOND VALIANT NAVION COVERED SEAL 46MM GRAFT WAS PLACED BELOW THE RENAL ARTERIES TO BRIDGE THE GAP BETWEEN THE FIRST NAVION AND THE ORIGINAL GORE GRAFT. 6 HELI-FX ENDOANCHORS WERE PLACED TO PREVENT THE STENT GRAFT FROM RIDING UP. ON FINAL ANGIOGRAM, BOTH RENAL ARTERIES WERE PERFUSED AND NO ENDOLEAK WAS SEEN. POST OP DAY ONE THE PATIENT HAS GOOD KIDNEY FUNCTION AND DOING WELL PER THE PHYSICIAN. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS UNKNOWN BUT COMMENTED THE CUFF PERFORMED DIFFERENTLY THAN EXPECTED BY JUMPING UP TO 2CM WITH DOWNWARD PRESSURE. NO ADD

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8543381 ↗