Valiant Navion™ VNMF3131C229TURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000100612), received between Dec 13, 2019 and Dec 13, 2019 — classified as 1 death.

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.

• DeathDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 200MM DIAMETER THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND A TYPE A DISSECTION WHICH EXTENDED TO THE DESCENDING THORACIC AORTA WAS DIAGNOSED. THE PATIENT WAS PREPPED FOR REPAIR AND DURING CT SCAN, IT WAS NOTED THAT THE VISCERAL VESSELS WERE NOT PATENT. IT WAS DECIDED TO PLACE A STENT GRAFT IN THE DESCENDING AORTA TO RE-ESTABLISH FLOW TO THE VISCERAL VESSELSAND IVUS WAS USED TO OBTAIN THE TRUE LUMEN. THE VALIANT NAVION WAS PLACED DISTAL TO THE SUBCLAVIAN ARTERY AND POST ANGIOGRAM STILL SHOWED NO FLOW TO THE VISCERAL VESSELS. STENTS WERE THEN PLACED IN THE CELIAC AND SMA TO SUCCESSFULLY RE-ESTABLISH FLOW. LACTATE LEVELS WERE ELEVATED POST-OP BUT BEGAN TO DECREASE TWO DAYS LATER AND SO THE PATIENT WAS EXTUBATED AND SEEMED ALERT AND ORIENTATED. THE NEXT DAY, THE PATIENT BECAME SHORT OF BREATH WHILE SITTING AND DIED. THE PHYSICIAN SAID THAT THE ASCENDING AORTA HAD RUPTURED AND THAT IT HAD BEEN PLANNED TO REPAIR THIS THE NEXT DAY AFTER THE PATIENT DIED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO THE COMPLEX THOR

  Patient problems: Death; Dyspnea

  MAUDE report 9465604 ↗