Valiant Navion™ VNMF3731C173TU (UDI 00763000260651)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000260651), received between Sep 15, 2022 and Jun 18, 2024 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. (B)(6) WERE IMPLANTED INTO ZONES 3 <(>&<)> 4. TECHNICAL SUCCESS WAS ACHIEVED.  IT WAS REPORTED THAT ABOUT 18 MONTHS LATER, THE PATIENT EXPIRED DUE TO AN UNKNOWN CAUSE. THE PATIENT HAD PREVIOUSLY NOT BEEN RESPONDING TO CONTACT ATTEMPTS.  THE SITE ASSESSED THE DEATH AS POSSIBLY RELATED TO THE DEVICE, NOT RELATED TO THE STUDY PROCEDURE AS POSSIBLY RELATED TO THE DISSECTION UNDER STUDY. THE MEDICAL MONITOR ASSESSED THE DEATH AS NOT RELATED TO THE STUDY DEVICE, STUDY PROCEDURE OR DISSECTION UNDER STUDY. THE CEC ASSESSED THE DEATH AS NOT RELATED TO STUDY DEVICE OR PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19555722 ↗
• MalfunctionDec 5, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION .  IT WAS REPORTED THAT CT IMAGING TAKEN 6 MONTHS LATER NOTED EXPANSION IN THE OUTER DIMENSIONS OF THE THORACIC AORTA RELATED TO CONTINUED EXPANSION OF FALSE LUMEN 59MM X 57MM AT ITS WIDEST. THERE WAS MILD PROGRESSIVE ENLARGEMENT OF SUPRA CELIAC ABDOMINAL AORTA DISTAL TO ILIAC. THERE WAS NO SECONDARY PROCEDURE PERFORMED. IT IS UNKNOWN IF THE CONTINUED FALSE LUMEN EXPANSION WAS IN AN AREA THAT WAS COVERED BY A STENT GRAFT. IT WAS REPORTED THAT THE PATIENT EXPIRED A FURTHER 6 MONTHS LATER. THE CAUSE OF DEATH WAS REPORTED AS A CARDIAC ARREST. THE PHYSICIAN HAS ASSESSED THE DEATH AS NOT RELATED TO THE DEVICE OR PROCEDURE. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15914057 ↗
• MalfunctionSep 15, 2022Leak/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 CORE LAB REVIEW OF CT IMAGING PERFORMED APPROXIMATELY 2 MONTHS POST THE INDEX PROCEDURE IDENTIFIED A TYPE IIIB ENDOLEAK. NO CAUSE OF THE ENDOLEAK WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15426236 ↗