Valiant Navion™ VNMC3737C182TU (UDI 00763000260859)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000260859), received between Dec 8, 2021 and Oct 15, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A DISSECTION. CORELAB REVIEWED CT IMAGING WHICH WAS TAKEN 6.5 YEARS LATER. NO ENDOLEAK, FRACTURE OR STENT RING MIGRATION WERE NOTED. A NEW STENT RING ENLARGEMENT OF + 1.4MM WAS OBSERVED ON RING 5 OF (B)(6). THE MAXIMUM AORTIC DIAMETER MEASURED 63MM. NO AORTIC ENLARGEMENT WAS OBSERVED. NOADDITIONAL CLINICAL SEQUALAE WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23276673 ↗
• 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 GR

  Patient problems: Vascular Dissection

  MAUDE report 17736064 ↗
• MalfunctionJul 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THREE VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION AS PART OF THE DISSECT-N STUDY. THE SITES REVIEW OF THE IMAGING APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE SHOWED NO SIGNIFICANT INTERVAL CHANGE. STABLE APPEARANCE OF THORACOABDOMINAL AORTA WITH ENDOVASCULAR STENT REPAIR OF DISTAL ARCH AND DESCENDING THORACIC AORTA. THE FALSE LUMEN IS THROMBOSED. THE MAX AORTIC DIAMETER WAS NOTED AS 49.8MM. CORE LAB REVIEW OF IMAGING FROM THE SAME IMAGING IDENTIFIED NEW STENT RING ENLARGEMENT ON RING 2 OF VNMC3737C182TU (+2.4MM). THE CAUSE OF THE STENT RING ENLARGEMENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 17257821 ↗
• MalfunctionJun 29, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE IT WAS REPORTED THAT A CT IMAGING WAS PERFORMED ONE MONTH LATER AND A FURTHER 6 MONTHS LATER . FROM THE FIRST IMAGING , CORELAB HAVE REVIEWED AND IDENTIFIED A IB (NEW) ENDOLEAK. NO STENT RING ENLARGEMENT WAS NOTED. A FRACTURE AND STENT RING MIGRATION WERE NOT EXAMINABLE DUE TO OVERLAP. THE MAXIMUM AORTIC DIAMETER WAS NOTED AS 57.6MM. AT THE NEXT CT IMAGING CORELAB OBSERVED THE PERSISTENT TYPE IB ENDOLEAK. NO STENT RING ENLARGEMENT WAS NOTED. A FRACTURE AND STENT RING MIGRATION WERE NOT EXAMINABLE DUE TO OVERLAP. MAXIMUM AORTIC ENLARGEMENT WAS NOTED AS 62MM. NO AORTIC ENLARGEMENT WAS NOTED. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17224207 ↗
• MalfunctionFeb 11, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN ANEURYSM AND DISSECTION.  IT WAS REPORTED APPROXIMATELY 10 MONTHS POST THE INDEX PROCEDURE FOLLOW-UP CT IDENTIFIED A TYPE IA ENDOLEAK AND AORTIC ENLARGEMENT.  PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK AND ENLARGEMENT ARE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13512403 ↗
• InjuryDec 8, 2021Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 55MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT RETURNED FOR A FOLLOW-UP OVER A YEAR LATER, WHERE AN UNKNOWN ENDOLEAK WAS OBSERVED. AS PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12961164 ↗