Valiant Navion™ VNMC4343C55TU (UDI 00763000260910)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000260910), received between Aug 26, 2020 and Jan 13, 2023 — classified as 2 deaths.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathJan 13, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 6 WEEKS POST THE INDEX PROCEDURE, FOLLOW UP CT IDENTIFIED A STENT INDUCED NEW ENTRY TEAR ARISING FROM THE RIGHT LATERAL PROXIMAL END OF THE ENDOGRAFT, LEADING TO A DISSECTION FLAP EXTENDING CAUDALLY INTO THE AORTIC ROOT + AORTIC ENLARGEMENT OF THE ASCENDING THORACIC AORTA FROM 41MM TO 48MM. INTERVENTION WAS PLANNED HOWEVER THE PATIENT EXPIRED ON THIS DATE PRIOR TO THE INTERVENTION. PER THE PHYSICIAN THE CAUSE OF DEATH WAS DUE TO THE ENDOLEAK. THE CAUSE OF THE ENDOLEAK IS UNDETERMINED.

  Patient problems: Insufficient Information; Myocardial Infarction; Vascular Dissection

  MAUDE report 16156485 ↗
• DeathAug 26, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 60MM IN LENGTH THORACIC DISSECTION. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER THE STENT WAS DEPLOYED THE TIP CAPTURE COULD NOT BE RECAPTURED RESULTING IN RETROGRADE DISSECTION. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Death; Intimal Dissection

  MAUDE report 10453172 ↗