Valiant Navion™ VNMF4040C183TU (UDI 00763000100728)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000100728), received between Jul 4, 2019 and Jun 25, 2024 — classified as 1 death, 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2024Fracture; Leak/Splash; Detachment of Device or Device Component; Fracture; Leak/Splash; Detachment of Device or Device Component

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION ON (B)(6) 2019. A CT ANGIO CHEST W/WO CONTRAST 7 DAYS POST THE INDEX PROCEDURE IDENTIFIED CONTRAST ENHANCEMENT IN THE PROXIMAL DESCENDING AORTA JUST DISTAL TO THE ARCH. ACCORDING TO THE IMPRESSION, THIS WAS MOST LIKELY DUE TO THE PATENCY OF THE EXCLUDED FALSE LUMEN RATHER THAN AN ENDOLEAK, THOUGH AN ENDOLEAK COULD NOT BE ENTIRELY EXCLUDED.  IT WAS REPORTED APPROXIMATELY 2 MONTHS POST THE INDEX PROCEDURE, FOLLOW UP CT SHOWED AORTIC ENLARGEMENT DUE TO AN INCREASE IN THE MURAL THROMBUS WITHIN THE FALSE LUMEN. NO FURTHER ACTION WAS TAKEN BASED ON THIS FINDING, AND THE SIZE OF THE ANEURYSM REMAINED RELATIVELY STABLE ON SUBSEQUENT SCANS 3 MONTHS AND 11 MONTHS POST THE INDEX PROCEDURE. IT WAS REPORTED APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE, FOLLOW-UP CT ANGIO CHEST W/WO CONTRAST SHOWED ANEURYSM ENLARGEMENT FROM 87MM TO 90MM, AND A TYPE IB ENDOLEAK AT INFERIOR MARGIN OF STENT GRAFT AT THE LEVEL OF THE DIAPHRAGM. THE PATIENT WAS SEEN BY THE PHYSICIAN WHO REVIEWED THE CT AND ALSO NOTED THERE IS A POSSIBLE ENDOLEAK AT THE SUPERIOR ASPECT OF THE GRAFT. PER THE PHYSICIAN THE CAUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19606355 ↗
• MalfunctionFeb 4, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED TYPE B AORTIC DISSECTION. IT WAS REPORTED WHEN THE PATIENT RETURNED FOR FOLLOW-UP 6 WEEKS LATER, A CT WAS PERFORMED WHICH REVEALED FALSE LUMEN FILLING. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11279217 ↗
• DeathOct 29, 2020Difficult or Delayed Positioning; Malposition of Device; Activation, Positioning or Separation Problem; Difficult or Delayed Positioning; Malposition of Device; Activation, Positioning or Separation Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE EMERGENT ENDOVASCULAR TREATMENT OF A 80MM RUPTURED THORACIC AORTIC ANEURYSM. THE PATIENT WAS HYPOTENSIVE AND WAS TAKEN DIRECTLY TO OR. THE PATIENT HAD EXTREMELY CALCIFIED ACCESS BILATERALLY, WHICH INCLUDED A TOTAL OCCLUSION OF THE LEFT PROXIMAL FEMORAL AND A FOCAL STENOSIS OF THE RIGHT EXTERNAL ILIAC. THE ANEURYSM BEGAN APPROXIMATELY 2.5CM FROM THE LEFT SUBCLAVIAN WITH THE DISTAL LANDING ZONE BEGINNING APPROXIMATELY 175MM FROM THE LEFT SUBCLAVIAN. THE PROXIMAL AND DISTAL LANDING ZONES MEASURED 35MM. DURING THE INDEX PROCEDURE, OPEN CUTDOWN WAS PERFORMED IN THE RIGHT FEMORAL ARTERY TO AID DELIVERY OF THE VALIANT NAVION'S DELIVERY SYSTEM. PRIOR TO ITS INSERTION, THE RIGHT EXTERNAL ILIAC ARTERY WAS PREDILATED WITH AN 8MMX 40MM NON MDT BALLOON AND A 16FR SHEATH. THE VALIANT NAVION DEVICE WAS THEN INTRODUCED OVER A STIFF WIRE. AFTER MULTIPLE ATTEMPTS THE DEVICE WOULD NOT TRACK THROUGH THE NATIVE FEMORAL ARTERY. A NON MDT BALLOON EXPANDABLE STENT WAS THEN IMPLANTED IN THE AREA OF THE RIGHT FEMORAL STENOSIS. THE DEVICE THEN TRACKED THROUGH THE NON- MDT STENT AND WAS ADVANCED TO THE INTENDED TARGET. THERE WAS HIGH RESISTANCE ON THE DELIVERY

  Patient problems: Death; Ruptured Aneurysm

  MAUDE report 10755651 ↗
• InjurySep 18, 2020Malposition of Device; Malposition of Device

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT APPROXIMATELY 6 MONTHS POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL WITH CHEST PAIN AND WEAKNESS. IT WAS STATED THAT A NEW DISSECTION WAS FOUND PROXIMALLY TO THE PROXIMAL GRAFT. THE EVENT WAS TREATED WITH A LEFT CAROTID TO LEFT SUBCLAVIAN BYPASS TWO DAYS LATER AND A TEVAR FOUR DAYS LATER WHERE A VNMF4040C183TU WAS IMPLANTED AS TREATMENT ALTHOUGH THE DEVICE DID NOT LAND AS CLOSE TO THE CAROTID ARTERY AS HAD BEEN PLANNED, A VNMF4040C103TU WAS THEN IMPLANTED ADDITIONALLY AS A PROXIMAL EXTENSION TO COMPLETE THE PROCEDURE. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS ANATOMY. THE PATIENT HAS HAD THREE SEPARATE DISSECTIONS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury; Insufficient Information

  MAUDE report 10552743 ↗
• MalfunctionJul 4, 2019Malposition of Device; Malposition of Device

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 180MM DISSECTION AND 58 MM THORACIC AORTIC ANEURYSM . IT WAS REPORTED THAT DURING THE PROCEDURE WHILE DEPLOYING THE STENT GRAFT VNMF4040C223TU THE DEVICE ¿SLIPPED¿ 15-20MM DISTALLY OF THE INTENDED LANDING ZONE. THE STENT GRAFT WAS 25% DEPLOYED AT THIS POINT. IT WAS REPORTED THAT THE STENT GRAFT WAS DEPLOYED ACCORDING TO THE IFU WITH FORWARD PRESSURE MAINTAINED ON THE STIFF WIRE AND THE DELIVERY SYSTEM. THE MEAN BLOOD PRESSURE WAS ALSO DROPPED TO 45MHG. THE FREEFLOW STENT WAS ALSO RELEASED AFTER THE REST OF THE STENT GRAFT HAD BEEN DEPLOYED. A SECOND VALIANT NAVION STENT GRAFT VNMF4040C183TU WAS THEN PLACED PROXIMALLY. IT WAS REPORTED THAT THIS STENT GRAFT WAS ALSO DEPLOYED IN THE SAME MANNER AS THE FIRST STENT GRAFT, BUT THIS ALSO DEPLOYED 5MM LOWER THAN INTENDED. IT WAS REPORTED THAT THE PHYSICIAN PUSHED FORWARD QUITE A BIT BUT STILL COULD NOT KEEP THE DEVICE FROM MIGRATING DURING DEPLOYMENT. POST DEPLOYMENT ANGIOGRAM SHOWED NO ENDOLEAK. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS LIKELY DUE TO THE LOCATION OF THE ANEURYSM ON THE GREATER CURVE OF THE AORTIC ARCH. THE PHYSICIAN A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8762241 ↗