Valiant Navion™ VNMC4040C218TU (UDI 00763000260903)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000260903), received between Jun 17, 2021 and Jun 21, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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.

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.

• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED TO TREAT A THORACIC DISSECTION. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE VIA THE DISSECT-N STUDY THAT THE PATIENT WAS ADMITTED WITH ABDOMINAL AND BACK PAIN AND IT WAS DISCOVERED VIA A CT THAT THE PATIENT HAD A TYPE-B DISSECTION EXTENDING FROM THE DISTAL END OF THE THORACIC STENT INTO THE LEFT COMMON ILIAC ARTERY. THE CAUSE OF THE EVENT IS UNDETERMINED. IT WAS NOTED THAT THE SITE ASSESSED THE EVENT AS RELATED TO THE DEVICE, NOT RELATED TO THE INDEX PROCEDURE AND RELATED TO THE DISSECTION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Abdominal Pain; Aneurysm; Pain; Vascular Dissection

  MAUDE report 17171439 ↗
• InjuryJun 17, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  2 VALIANT NAVION THORACIC STENT GRAFTS AND 2 INVESTIGATIONAL DEVICE-VISCERAL MANIFOLD STENT GRAFTS WERE IMPLANTED FOR AN EMERGENT ENDOVASCULAR TREATMENT OF A RUPTURED ANEURYSM AS WELL AS TREATMENT OF VISCERAL VESSELS. COMPLETION ANGIOGRAM DEMONSTRATED GOOD FLOW TO THE CELIAC, SMA, RENALS, AS WELL AS FLOW TO THE INFRARENAL SEGMENT AND BILATERAL ILIAC ARTERIES. THE PATIENT WAS DISCHARGED HOME ON POST-OPERATIVE DAY 5. IT WAS REPORTED THE PATIENT WAS NON COMPLIANT WITH FOLLOW-UP VISITS. 167 DAYS POST IMPLANT IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY AT A LOCAL EMERGENCY ROOM WITH ACUTE ONSET OF CHEST DISCOMFORT AND HIGH BLOOD PRESSURE. A CTA PERFORMED SHOWED A RETROGRADE AORTIC DISSECTION EXTENDING FROM THE NAVION GRAFTS USED AS A PROXIMAL EXTENSION AS WELL AS A TYPE IIIB ENDOLEAK AT THE INVESTIGATIONAL DEVICE MANIFOLD JUNCTION OF THE NON MDT STENT AND CELIAC LIMB. DUE TO THE PATIENTS HISTORY OF DRUG ABUSE, A URINE ANALYSIS CAME BACK POSITIVE FOR METHAMPHETAMINES, OPIATES (LIKELY FROMPAIN MEDICATION ADMINISTERED WHILE IN HOSPITAL), AND AMPHETAMINES. THE NEXT DAY, THE PATIENT UNDERWENT A LEFT CAROTID TO SUBCLAVIAN BY PASS WITH A PROXIMAL EXTENSION USING NON-MDT STENT GRAFTS AND M

  Patient problems: High Blood Pressure/ Hypertension; Vascular Dissection

  MAUDE report 12015289 ↗