Valiant Navion™ VNMC4337C200TU (UDI 00763000261054)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000261054), received between Feb 16, 2021 and Feb 16, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2021Malposition of Device; Material Deformation; Malposition of Device; Material Deformation

  A VALIANT NAVION STENT GRAFT WAS ATTEMPTED TO BE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 30 MM THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, A VNMC4337C200TU TO TREAT A TBAD. THE PROXIMAL TEAR WAS 7CM FROM THE LSA, AND THE PROXIMAL LANDING ZONE WAS AT THE LSA. THE DEVICE WAS DEPLOYED ACCORDING TO IFU, BUT THE BLOOD PRESSURE REMAINED AT 114 MM/HG. IT WAS STATED THAT THE DEPLOYMENT OF THE GRAFT AND THE NOSE CONE WERE COMPLETED WITHOUT INCIDENT, AND THE DELIVERY SYSTEM WAS REMOVED UNDER FLURO WITHOUT NOTICEABLY GETTING CAUGHT ON THE GRAFT. AN ANGIOGRAM WAS PERFORMED, WHERE IT WAS NOTED THAT PROXIMAL END OF GRAFT APPEARING TO BE MISALIGNED AND SEVERAL STENT SEGMENTS BUNCHES UP AND TWISTED ALONG THE INNER CURVE. INSTEAD OF THE 3 PROXIMAL RO MARKETS ALIGNING, ONE OF THE RO MARKETS APPEARED SIGNIFICANT LH FURTHER BACK FROM THE OTHER 2, DESPITE THE GRAFT BEING DEPLOYED WITH PARALLAX ELIMINATED. THE PHYSICIAN THEN DECIDED TO IMPLANT A SECOND VNMC4337C200TU TO RELINE THE FIRST GRAFT TO ENSURE THE AORTA WAS WIDELY PATENT AND THE FALSE LUMEN WAS CLOSED OFF. THE SECOND DEVICE WAS DEPLOYED WITHOUT INCIDENT AND THE FINAL ANGIE SHOWED SUCCESSFUL EX

  Patient problems: Insufficient Information

  MAUDE report 11332231 ↗