Valiant Navion™ VNMF2020C96TU (UDI 00763000100520)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000100520), received between Jul 9, 2021 and Jul 14, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.

Recalls naming this device

1. Feb 12, 2021Open, 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.

• MalfunctionJul 14, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT A CT WAS PERFORMED APPROXIMATELY 1 YEAR LATER, WHERE A TYPE 1B ENDOLEAK WAS OBSERVED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS PATIENT'S ANATOMY DUE TO A NARROW AND CALCIFIED DISTAL SEAL ZONE. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12166656 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED FOR A 30 MM THORACIC AORTIC DISSECTION. APPROXIMATELY 16 MONTHS POST PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF CHEST PAIN, WHERE WHAT APPEARS TO BE THROMBUS IN THE DISTAL ASPECT OF THE GRAFT WAS OBSERVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 12142354 ↗