Valiant Navion™ VNMF4640C185TU (UDI 00763000100896)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000100896), received between Feb 22, 2019 and Jul 16, 2025 — classified as 2 deaths, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2025Leak/Splash; Leak/Splash

  CORELAB REVIEW OF CTS TAKEN APPROXIMATELY 2 YEARS AND 2 MONTHS POST-INDEX PROCEDURE IDENTIFIED A NEW TYPE IB ENDOLEAK INVOLVING THE DEVICE VNMF4640C185TU (SN (B)(6)) . THE MAXIMUM AORTIC DIAMETER MEASURED 78MM. NO AORTIC ENLARGEMENT, STENT RING ENLARGEMENT OR STENT RING MIGRATION WAS OBSERVED. THE IMAGE WAS NO EVALUABLE FOR FRACTURE DUE TO DEVICE OVERLAPS. CORELAB REVIEW OF CTS TAKEN 10 MONTHS LATER CONFIRMED A PERSISTENT TYPE IB ENDOLEAK IN THE SAME VALIANT NAVION STENT GRAFT. THE MAXIMUM AORTIC DIAMETER MEASURED 80MM. NO AORTIC ENLARGEMENT, STENT RING ENLARGEMENT OR STENT RING MIGRATION WAS OBSERVED. IT WAS NOTED THAT FRACTURE EVALUATION WAS DIFFICULT DUE TO MULTIPLE DEVICE OVERLAPS. THE CAUSE OF THE TYPE IB ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22517651 ↗
• DeathDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT ONE WEEK LATER, THE PATIENT HAD A HEMORRHAGE. THE PATIENT DID THEN NOT ATTEND THEIR 1 MONTH FOLLOW-UP APPOINTMENT. IT WAS REPORTED THAT THE PATIENT'S WIFE CALLED SIX WEEKS POST THE PROCEDURE INFORMING THAT HER HUSBAND HAD DIED TWO DAYS FOLLOWING DISCHARGE AND THE PHYSICIAN AT THE ER NOTED THE ABDOMEN WAS FULL OF BLOOD AND THE PATIENT SUBSEQUENTLY EXPIRED. THE SPONSOR ASSESSED THE EVENT AS RELATED TO DEVICE AND PROCEDURE. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Atrial Fibrillation; Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10958310 ↗
• DeathMar 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 70 MM DIAMETER THORACIC AORTIC ANEURYSM. THE PATIENT HAD A SURGICAL ABDOMINAL REPAIR IN THE PAST. A SPINAL DRAIN WAS PLACED.   IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, DUE TO SEVERE VESSEL TORTUOSITY, THE FIRST VALIANT NAVION DEVICE (VNMC4040C175TU) WAS INSERTED VIA THE LEFT FEMORAL ARTERY. THE DEVICE COULD NOT TRAVERSE THE TORTUOUS ANATOMY IN THE DESCENDING THORACIC AORTA, DESPITE SEVERAL ATTEMPTS. THE DEVICE WAS THEN REMOVED FROM THE PATIENT, WITHOUT BEING IMPLANTED. IT WAS REPORTED THAT THE PHYSICIAN THEN OPTED FOR THE "BODYFLOSS" TECHNIQUE, WITH A GUIDEWIRE FROM THE LEFT BRACHIAL AND THE LEFT FEMORAL. A SECOND VALIANT NAVION (VNMF4040C183TU) WAS INSERTED AND DEPLOYED WITHOUT ISSUE. TWO ADDITIONAL VALIANT NAVION STENT GRAFTS WERE SUBSEQUENTLY IMPLANTED (VNMF4640C185TU AND VNMF4640C185TU) SUCCESSFULLY TO COMPLETE THE PROCEDURE. BALLOONING WAS PERFORMED WITH A RELIANT BALLOON. IT WAS REPORTED THAT AFTER THE PROCEDURE, THE PATIENT DEVELOPED PARAPLEGIA. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED. THE PHYSICIAN STATED THAT "DUE TO THE ABDOMINAL SURGICAL AAA RE

  Patient problems: Death; Paralysis

  MAUDE report 8443232 ↗
• InjuryFeb 22, 2019Activation, Positioning or Separation Problem; Device Damaged by Another Device; Material Deformation; Activation, Positioning or Separation Problem; Device Damaged by Another Device; Material Deformation

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 65MM THORACIC ANEURYSM. IT WAS NOTED THE PATIENT HAD A PREVIOUS OPEN AORTIC BI FEMORAL REPAIR AND THERE WERE STENTS PLACED IN THE LIMBS OF THE OPEN REPAIR GRAFT. IT WAS REPORTED DURING THE INDEX PROCEDURE SEVERAL ATTEMPTS WERE MADE TO ADVANCE THE DEVICE THROUGH THE PATIENTS LEFT LIMB DUE TO RESISTANCE. A 22FR SHEATH WAS THEN ADVANCED AS FAR AS POSSIBLE THROUGH THE LIMB AND THE DEVICE WAS REINSERTED THROUGH THE SHEATH INTO THE AORTA. THE DEVICE WAS DEPLOYED WITHOUT DIFFICULTY BUT THE MIDDLE OF THE STENT GRAFT FAILED TO OPEN. THE DELIVERY SYSTEM WAS REMOVED AND THE PHYSICIAN ATTEMPTED TO BALLOON THE DEVICE TO GET IT TO OPEN BUT THERE APPEARED TO BE A 5MM SECTION THAT WAS CONSTRAINED TO ABOUT 16MM. UNDER FLUOROSCOPY A SECTION OF THE ILIAC STENT WAS OBSERVED TO BE STUCK ON THE STENT GRAFT LEADING TO THE GRAFT BEING CONSTRAINED. SEVERAL ATTEMPTS WERE MADE TO BALLOON OUT THE STENT TO BREAK IT AWAY FROM THE GRAFT BUT THEY WERE UNSUCCESSFUL . DUE TO THE STENT CONSTRAINING THE GRAFT, THE DISTAL END OF THE GRAFT DID NOT LAND IN THE INTENDED PLACE. THE PHYSICIAN ELECTED TO IMPLANT A 43X55 NAVION STENT TO EXT

  Patient problems: Injury

  MAUDE report 8361101 ↗