Valiant Navion™ VNMC2828C182TU (UDI 00763000260750)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000260750), received between Nov 12, 2021 and Oct 11, 2022 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFTS WERE IMPLANTED  FOR AN UNKNOWN ENDOVASCULAR PROCEDURE . IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT INTERVENTION INVOLVING AN ELEPHANT TRUNK TECHNIQUE. IT IS UNKNOWN IF THE PROCEDURE WAS RELATED TO THE VALIANT NAVION IMPLANTS. NO CAUSE WAS REPORTED. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 15579498 ↗
• InjuryNov 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN AN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THE PATIENT WAS HAVING UNKNOWN SYMPTOMS. AN ANGIOGRAM WAS PERFORMED WHICH SHOWED NO EVIDENCE OF A LEAK AS PER THE PHYSICIAN, ALTHOUGH IT WAS STATED BY A RADIOLOGIST THERE WAS A POSSIBILITY OF A TYPE III ENDOLEAK PROXIMALLY. INTERVENTION WAS PERFORMED APPROXIMATELY 33 MONTHS POST IMPLANT, AND AN ADDITIONAL VALIANT STENT GRAFT WAS IMPLANTED. ALTHOUGH THERE WAS NO LEAK FOUND, BUT THE PROXIMAL SEAL ZONE WAS VERY SHORT SO IT WAS DECIDED TO PLACE A GRAFT WITHIN THE EXISTING GRAFT EXTENDING THE EXISTING GRAFT BY APPROXIMATELY 20MM. IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED A DISTAL EXTENSION APPROXIMATELY 10 MONTHS LATER. REPLACED A VAMF 2828C150TU DOWN TO THE CELIAC AND IT WAS PLACED PERFECTLY. IT WAS REPORTED THE DISTAL EXTENSION WAS PLACED TO COVER AN ANEURYSMAL SECTION FROM THE DISTAL MARGIN IN THE EXISTING GRAFT TO THE CELIAC ARTERY. 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: Aneurysm

  MAUDE report 12801992 ↗