Valiant Navion™ VNMC2828C182TU (UDI 00763000100964)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000100964), received between Jan 15, 2019 and Jul 4, 2024 — classified as 2 deaths, 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A DISSECTION. IT WAS REPORTED APPROXIMATELY 3 YEARS FOLLOW-UP CT SHOWED POST-SURGICAL CHANGES OF THE TEVAR WITH UNCHANGED EXTENT OF THE RESIDUAL DISSECTION EXTENDING TO THE RIGHT EXTERNAL AND LEFT INTERNAL ILIAC ARTERIES AND A SLIGHTLY INCREASED SIZE OF THE PROXIMAL ABDOMINAL AORTA JUST DISTAL TO THE STENT GRAFT MEASURING 32X30MM COMPARED TO 31X29MM PREVIOUSLY. NO CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm; Vascular Dissection

  MAUDE report 19674759 ↗
• MalfunctionOct 10, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED TAA ON THE (B)(6) 2020.  IT WAS REPORTED CT IMAGING WAS PERFORMED ON (B)(6) 2020. THE MAXIMUM AORTIC DIAMETER MEASURED 63.3MM. NO STENT RING ENLARGEMENT OR ANY ENDOLEAK WERE NOTED. FRACTURES AND STENT RING MIGRATION WERE NOT EXAMINABLE DUE TO CALCIFICATION. FURTHER CT IMAGING ON (B)(6) 2020 REVEALED A NEW TYPE II ENDOLEAK.  THE MAXIMUM AORTIC DIAMETER MEASURED 59.3MM. NO STENT RING ENLARGEMENT OR AORTIC ENLARGEMENT WERE OBSERVED. STENT RING MIGRATION AND FRACTURE WERE NOT EXAMINABLE DUE TO CALCIFICATION. ON (B)(6) 2022, A NEW IIIB ENDOLEAK WAS NOTED ON STENT GRAFT (B)(6). NO STENT RING ENLARGEMENT OR AORTIC ENLARGEMENT. STENT RING MIGRATION AND FRACTURE WERE NOT EXAMINABLE. MAXIMUM AORTIC DIAMETER MEASURED 64.3MM. FURTHER CT IMAGING ON (B)(6) 2022, DID NOT IDENTIFY ANY ENDOLEAK OR STENT RING ENLARGEMENT. FRACTURE AND STENT RING MIGRATION WERE NOT EXAMINABLE. THE AORTIC DIAMETERS MEASURED 64.9MM AND 54.9MM RESPECTIVELY. ON (B)(6) 2022, CT IMAGING SHOWED THE PERSISTANT TYPE IIIB ENDOLEAK ON (B)(6). NO STENT RING ENLARGEMENT OR AORTIC ENLARGEMENT WERE OBSERVED. STENT RING MIGRATION AND FRACTURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17903454 ↗
• MalfunctionJan 25, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION. IT WAS REPORTED ONE MONTH POST THE INDEX PROCEDURE FOLLOW UP CT IDENTIFIED AN UNDETERMINED ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16240371 ↗
• MalfunctionJun 20, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. TWO FURTHER VALIANT NAVION STENT GRAFTS WERE IM PLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE.  IT WAS REPORTED APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY. CT SHOWED THE PRESENCE OF A TYPE III ENDOLEAK.  AS PER THE PHYSICIAN THE CAUSE OF THE TYPE III ENDOLEAK IS UNKNOWN.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14742434 ↗
• DeathMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 11 MONTHS POST THE INDEX PROCEDURE A POST SURGERY CT SHOWED A PATENT STENT GRAFT. THERE WAS INTERVAL ENLARGEMENT OF THE DESCENDING THORACIC AORTA WHICH MEASURED 44 X 42MM WITH A NORMAL ABDOMINAL AORTA OBSERVED. IT WAS NOTED THE DISTAL AORTA HAD INCREASED BY 14MM. THE PATIENT EXPIRED 12 MONTHS POST THE INDEX PROCEDURE. AS PER THE PHYSICIAN THE CAUSE OF THE ANEURYSM ENLARGEMENT AND DEATH IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Aneurysm; Insufficient Information

  MAUDE report 14545844 ↗
• InjuryMar 20, 2019Malposition of Device; Malposition of Device

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION. STENT OVERSIZING WAS BETWEEN 0-5%. IT WAS REPORTED DURING THE INDEX PROCEDURE THE PHYSICIAN HAD PLANNED TO IMPLANT THE DEVICE IN ZONE 2, HOWEVER NOTED THE PATIENT HAD A SEVERELY ANGULATED ARCH. THE DEVICE WAS NOT DEPLOYED USING RAPID PACING HOWEVER GOOD BLOOD PRESSURE CONTROL WAS MAINTAINED. (MEAN ARTERIAL PRESSURE OF 55 (90/40 WITH A HEART RATE OF 60BPM). THE PHYSICIAN ALIGNED THE DEVICE IMMEDIATELY ADJACENT TO THE LEFT COMMON CAROTID AND THE STENT GRAFT WAS DEPLOYED SUCCESSFULLY BUT DURING RELEASE OF THE TIP CAPTURE, THE DEVICE APPEARED TO JUMP DISTALLY. THE PHYSICIAN STATED THAT THE DEVICE ALSO APPEARED TO ACCORDION WITH OVERLAP OF THE ADJACENT STENTS ON THE INNER CURVE OF THE ANATOMY. HELI-FX ENDOANCHORS WERE THEN ALSO IMPLANTED DURING THE PROCEDURE TO PREVENT ANY FURTHER DISTAL MIGRATION IN LIEU OF PLACING AN ADDITIONAL PROXIMAL EXTENSION.. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS RELATED TO A LACK OF RADIAL STRENGTH IN THE STENT GRAFT RESULTING IN "STACKING" OF THE STENTS ALONG THE GREATER CURVATURE OF THE ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE

  Patient problems: Injury

  MAUDE report 8435602 ↗
• DeathJan 15, 2019Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 70MM DIAMETER THORACIC AORTIC ANEURYSM. THERE WAS A PRE-OPERATIVE ANEURYSM RUPTURE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, IT WAS INTENDED TO IMPLANT THE DEVICE FROM THE DISTAL EDGE OF LEFT COMMON CAROTID TO THE MID DESCENDING THORACIC AORTA. THE DEVICE WAS INTRODUCED AND DEPLOYED PRECISELY AT THE LOCATION IDENTIFIED. NO ADDITIONAL RUNS WERE DONE PRIOR TO DEPLOYMENT. THE GRAFT APPEARED TO BE PERFECTLY PLACED, HOWEVER A POST IMPLANT RUN WAS INITIATED AND IT WAS DISCOVERED THAT THE LEFT COMMON CAROTID HAD BEEN COVERED BY THE STENT GRAFT. LEFT ARM ACCESS WAS MADE AND A WIRE WAS PLACED TO CROSS THE COVERED PORTION OF THE LEFT COMMON CAROTID. IT WAS REPORTED THAT THE WIRE CAUSED A DISSECTION PLANE NECESSITATING EMERGENT CAROTID/CAROTID-CAROTID/SUBCLAVIAN BYPASS. THE PHYSICIAN COMMENTED THAT THE COVERAGE OF THE LEFT COMMON CAROTID WAS LIKELY DUE TO THE PATIENT ANATOMY AND NOT A DEVICE ISSUE. THE PROBLEM WAS CAUSED BY THE INADVERTENT WIRE PLACEMENT CREATING A DISSECTION PLANE PROXIMAL TO THE LEFT COMMON CAROTID. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL IN THE ICU THREE HOURS POST-O

  Patient problems: Blood Loss; Death; Intimal Dissection; Occlusion; Rupture

  MAUDE report 8247439 ↗