Valiant Navion™ VNMF4040C223TURecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000100735), received between Jul 4, 2019 and Dec 19, 2023 — classified as 3 deaths, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• DeathDec 19, 2023Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN 81MM THORACIC AORTIC ANEURYSM ON THE (B)(6) 2020. VALIANT NAVION STENT GRAFT (VNMF4040C103TU) WAS IMPLANTED DISTAL TO LSCA, FOLLOWED CLOSELY BY (B)(6), STENT GRAPH (B)(6) WAS IMPLANTED JUST PROXIMAL TO CELIAC TAKEOFF. IT WAS REPORTED APPROXIMATELY 7 MONTHS POST THE INDEX PROCEDURE, FOLLOW UP CT IMAGING REVEALED A PERSISTENT TYPE II ENDOLEAK ALONG THE PROXIMAL DESCENDING THORACIC AORTA, SPECIFICALLY ALONG THE UNDERSURFACE OF THE AORTIC ARCH AND ANTERIOR TO THE PROXIMAL DESCENDING THORACIC AORTA. THERE WAS A SLIGHT INCREASE IN THE SIZE OF THE ACTIVE CONTRAST FLOW WITHIN THE EXCLUDED ANEURYSM SAC (26 X 16 MM, COMPARED TO 11 X 8 MM PREVIOUSLY) IN THE ARTERIAL PHASE, BUT THE OVERALL SIZE OF THE THORACIC AORTIC ANEURYSM DIAMETERS REMAINED STABLE. THE TWO PROXIMAL VALIANT NAVION DEVICES WERE MOST IMPLICATED BY THE TYPE II ENDOLEAK WHICH APPEARED TO BE SUPPLIED BY AN INTERCOSTAL ARTERY. IT WAS ALSO NOTED THAT (B)(6) HAD SLIGHTLY MIGRATED. APPROXIMATELY 12 MONTHS POST THE INDEX PROCEDURE, IT WAS REPORTED THAT THE PATIENT HAD EXPIRED. PER THE PHYSICIAN THE CAUSE OF THE TYPE II ENDOLEAK AND SUB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356467 ↗
• DeathJun 13, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE . IT WAS REPORTED THAT A IB ENDOLEAK WAS IDENTIFIED. TWO DAYS LATER, THE PATIENT SUBSEQUENTLY EXPIRED. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS DISEASE PROGRESSION DISTAL ENLARGEMENT. THE CAUSE OF THE PATIENTS DEATH WAS A MYOCARDIAL INFRACTION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Myocardial Infarction

  MAUDE report 17118034 ↗
• MalfunctionMay 26, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALAINT NAVION STENT GRAFTS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION.  IT WAS REPORTED THAT AN UNKNOWN ENDOLEAK WAS OBSERVED ON  A CT TAKEN 10 DAYS LATER. NO CAUSE FOR THE UNKNOWN ENDOLEAK AS PER THE PHYSICIAN WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14511288 ↗
• InjuryJul 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 223MM THORACIC AORTIC DISSECTION. IT WAS NOTED THAT THE DEVICE WAS IMPLANTED FROM THE LSA TO THE MID DESCENDING THORACIC AORTA. IT WAS REPORTED THAT POST-OPERATIVELY, AFTER CSF DRAINAGE WAS REMOVED A WEEK LATER, THE PHYSICIAN STATED THAT THEY RE-ESTABLISHED ANOTHER CSF DRAIN BUT THE PATIENT HAD PARAPLEGIA SYMPTOMS. IT WAS NOTED THAT THE INDEX PROCEDURE WAS PERFORMED WITHOUT ISSUE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED BUT THAT THE PATIENT HAD AN EXISTING AUI AND FEM-FEM AND THE PHYSICIAN THOUGHT THAT HAVING THE PREVIOUS AAA REPAIR MAY HAVE CONTRIBUTED TO THE PARAPLEGIA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Paraplegia

  MAUDE report 10218218 ↗
• DeathNov 6, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN HAD TO PUSH THE DELIVERY SYSTEM TO DELIVER IT TO THE LANDING ZONE, DUE TO THE PATIENT'S SEVERE TORTUOSITY DISTAL TO A PREVIOUSLY PLACED STENT GRAFT. AFTER SUCCESSFUL DELIVERY AND PLACEMENT OF THE NAVION STENT GRAFT, THE PATIENT'S BLOOD PRESSURE DROPPED. ANGIOGRAPHY DISTAL TO THE STENT GRAFT SHOWED A THORACIC RUPTURE. THE PATIENT EXPIRED DURING THE PROCEDURE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO THE PATIENT'S TORTUOUS ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Death; Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 9283703 ↗
• InjuryJul 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 AL

  Patient problems: Injury

  MAUDE report 8762242 ↗