Valiant Navion™ VNMF4343C223TU (UDI 00763000260569)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000260569), received between Nov 12, 2020 and Nov 12, 2020 — classified as 1 injury.

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

• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 55MM ABDOMINAL AORTIC ANEURYSM. A CT PERFORMED JUST OVER 7 YEARS LATER REVEALED A TYPE IA AND TYPE II ENDOLEAK FROM LUMBAR ARTERIES AND A SAC DIAMETER OF 65MM. DURING THE SAME CT, IT WAS FOUND THE PATIENT HAD A NEW THORACIC PAU (PENETRATING ATHEROSCLEROTIC ULCER (PAU). THE PHYSICIAN DECIDED TO TREAT THE PAU 3 DAYS LATER. TWO VALIANT NAVION STENT GRAFTS WERE IMPLANTED AS TREATMENT. IT WAS REPORTED THAT SHORTLY AFTER THIS PROCEDURE, THE PATIENT SUFFERED A CEREBRAL VASCULAR ACCIDENT (CVA) AND WAS RECOVERING IN HOSPITAL. AS PER THE PHYSICIAN, THE CAUSE OF THE CVA WAS UNCONTROLLABLE HIGH BLOOD PRESSURE. THE CAUSE OF THE IA ENDOLEAK WAS ANATOMY AND A HOSTILE ANGLED AORTIC NECK WITH CONTINUED DILATION OF THE AORTA. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: High Blood Pressure/ Hypertension; Stroke/CVA

  MAUDE report 10828469 ↗