Valiant Navion™ VNMC3731C207TU (UDI 00763000261030)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000261030), received between May 24, 2021 and Sep 13, 2023 — 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.

• InjurySep 13, 2023Fracture; Leak/Splash; Fracture; 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 GR

  Patient problems: Insufficient Information

  MAUDE report 17736055 ↗
• InjuryMay 24, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A PAU. THREE MONTHS POST INDEX, THE PATIENT EXPERIENCED SEVERE CHEST PAINS AND FAINTED. A TYPE IA ENDOLEAK WAS OBSERVED FROM DISEASE PROGRESSION. THE FOLLOWING DAY, A SECONDARY PROCEDURE WAS PERFORMED TO EXTEND THE ENDOGRAFT TO THE LCC. A J-WIRE WAS PLACED FROM THE LEFT GROIN IN PREPARATION WHILE A SECOND SURGEON PERFORMED LCC-LSA BYPASS. AFTER THE BYPASS WAS COMPLETED, AN IVUS WAS TAKEN TO CONFIRM THE AORTIC DIAMETER AT THE LCC. A PIGTAIL CATHETER WAS INTRODUCED FROM THE LEFT RADIAL FOR AN INITIAL RUN WHICH THEN REVEALED A RETROGRADE TYPE A DISSECTION. IT WAS ALSO REPORTED, THE PATIENT SUFFERED AORTIC INSUFFICIENCY AND A PLURAL EFFUSION. THE ENDOVASCULAR TEVAR PROCEDURE WAS CANCELLED AND THE SURGEON PROCEEDED WITH OPEN REPAIR WITH ARCH SEWING ELEPHANT TRUNK TO THE PROXIMAL SEGMENT OF THE EXISTING NAVION GRAFT WAS PERFORMED. THE TYPE IA WAS REPORTED TO BE CAUSED BY DISEASE PROGRESSION. NO CAUSE OF THE DISSECTION WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain; Pleural Effusion; Syncope/Fainting; Valvular Insufficiency/ Regurgitation; Vascular Dissection

  MAUDE report 11869467 ↗