Valiant Navion™ VNMF3125C173TU (UDI 00763000260637)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000260637), received between Sep 13, 2023 and Jul 18, 2024 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2024Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A IMH AND PAU. IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT SHOWED THAT AN INCREASED ENDOLEAK AT THE LEVEL OF THE DISTAL ENDOGRAFT WAS NOTED. SPECIFICALLY, "BROAD-BASED CONTRAST OPACIFICATION EXTERNAL TO THE MEDIAL ASPECT OF THE DISTAL GRAFT PERSISTS AND IS SIMILAR IN APPEARANCE". PER THE PHYSICIAN THE CT "DEMONSTRATED EVIDENCE OF DSINE VERSUS TYPE IB ENDOLEAK". THIS ENDOLEAK WAS THOUGHT TO BE A TYPE II ENDOLEAK ON CT A YEAR PREVIOUSLY AND IS NOW DEEMED TO BE IB ENDOLEAK. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Vascular Dissection

  MAUDE report 19771203 ↗
• InjurySep 13, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT (B)(6) WAS IMPLANTED IN A ENDOVASCULAR TREATMENT OF A TYPE A AORTIC DISSECTION ON THE (B)(6) 2020 .A HEMI ARCH REPAIR WAS ALSO PERFORMED. FOUR MORE VALIANT NAVION STENT GRAFTS (B)(6) WERE IMPLANTED 2 MONTHS LATER FOR THE TREATMENT OF A TYPE A AORTIC DISSECTION WITH DISTAL EXTENSION AND A SYMPTOMATIC DISTAL THORACIC AORTIC ANEURYSM. DURING THE SECOND PROCEDURE, AN AORTOGRAPHY AND INTRAOPERATIVE VASCULAR ULTRASOUND REVEALED A WELL POSITIONED PREVIOUS TVAR IN THE TRUE LUMEN COVERING THE ORIFICE OF THE LEFT SUBCLAVIAN ARTERY, WHICH WAS COILED PREVIOUSLY. A TYPE I ENDOLEAK WITH FALSE LUMEN MEASURING 31 X 34MM WAS ALSO NOTED. USING A NON MDT SHEATH, THE 37 X 31 X 207MM VALIANT NAVION WAS DEPLOYED FIRSTLY IN THE TRUE LUMEN FOLLOWED BY THE 31 X 25 X 173MM STENT GRAFT WHICH WAS EXTENDED DOWN TO THE CELIAC ARTERY. SUBSEQUENTLY, INTRAVASCULAR ULTRASOUND SHOWED EXCELLENT PLACEMENT OF THE STENT GRAFTS WITH WIDELY OPENED CELIAC ARTERY. COMPLETION ANGIOGRAM REVEALED GOOD FLOW IN THE TRUE LUMEN. THERE WAS STILL FLOW AND PROXIMAL LEAK OBSERVED AT THE LEVEL OF THE PROXIMAL DESCENDING THORACIC AORTA. THEREFORE, THE FALSE LUMEN WAS STENTED WITH A 34 X 28 X 207MM STENT GRAF

  Patient problems: Insufficient Information

  MAUDE report 17736089 ↗