Valiant Navion™ VNMC4034C200TU (UDI 00763000101251)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000101251), received between Jul 1, 2021 and Oct 15, 2025 — classified as 2 deaths, 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (13 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE . IT WAS REPORTED THAT CORELAB REVIEWED CTS DATED OVER FIVE YEAR LATER AND IDENTIFIED STENT RING ENLARGEMENT OF +2.9MM ON RING 5 OF THE STENT GRAFT. THE MAXIMUM AORTIC DIAMETER IS 50.4MM. NO ENDOLEAK, FRACTURE OR STENT RING DISPLACEMENT WAS OBSERVED. NO CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300474 ↗
• MalfunctionJul 3, 2024Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR REPAIR OF A TAA. IT WAS REPORTED A FOLLOW UP CT REVIEWED BY THE PHYSICIAN SHOWED A SUSPECTED TYPE III ENDOLEAK. CORE LAB REVIEW OF THE SAME IMAGING ( APPROXIMATELY 4 YEARS AND 9 MONTHS AFTER THE INDEX PROCEDURE) IDENTIFIED A NEW TYPE IA ENDOLEAK WITH A MAXIMUM AORTIC DIAMETER OF 73.8MM AND PERSISTENT AORTIC ENLARGEMENT OF +19.7MM WHEN COMPARED TO CT IMAGING (APPROXIMATELY 3.5 WEEKS AFTER THE INDEX PROCEDURE). NO STENT RING ENLARGEMENT, STENT RING MIGRATION OR STENT FRACTURE WERE OBSERVED. THE CAUSE OF THE ENDOLEAK AND ANEURYSM ENLARGEMENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19664452 ↗
• InjuryMay 27, 2024Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION. 2 MONTHS LATER, A RESECTION AND PATCH ANGIOPLASTY WAS COMPLETED FOR A RIGHT CFA PSEUDOANEURYSM. IT WAS REPORTED APPROXIMATLEY 13 MONTHS POST THE INDEX PROCEDURE, FOLLOW UP CT SHOWED A TYPE IA ENDOLEAK AND ANEURYSM ENLARGEMENT. APPROXIMATELY 15 MONTHS LATER FOLLOW UP CT SHOWED A TYPE IA ENDOLEAK AND ANEURYSM ENLARGEMENT. A SECONDARY PROCEDURE WAS PERFORMED. THORACIC ENDOVASCULAR AORTIC REPAIR BY RELINING OF THE ENTIRE PRIOR TEVAR DISTAL TO THE LSA WITH A NON MDT GRAFT DUE TO WITH PROXIMAL EXTENSION OF THE PRIOR TEVAR WITH THORACIC BRANCHED ENDOGRAFT (TBE) DEPLOYED DISTAL TO LEFT CAROTID ARTERY (ZONE 2) WITH COVERAGE OF LSA, STENT-GRAFT DEPLOYMENT IN LEFT SUBCLAVIAN ARTERY INTO THORACIC BRANCHED DEVICE, RELINING/STENTING OF LEFT RENAL ARTERY STENT WITH SELF-EXPANDING STENT WAS COMPLETED. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 19400586 ↗
• InjuryApr 23, 2024Fracture; Leak/Splash; Detachment of Device or Device Component; Material Deformation; Adverse Event Without Identified Device or Use Problem; Fracture; Leak/Splash; Detachment of Device or Device Component; Material Deformation; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT (VNMC4034C200TU) WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION 2 ADDITIONAL VALIANT NAVION STENT GRAFTS (VNMC4337C200TU & VNMC4034C200TU) WERE IMPLANTED 18 MONTHS LATER. IT WAS REPORTED UNDER FOUR YEARS LATER, A FOLLOW UP CT SHOWED A SEAM SEPARATION(S) IN THE VALIANT NAVION STENT GRAFTS. IT IS UNKNOWN WHICH NAVION GRAFT IS AFFECTED. INTERVENTION WAS PERFORMED WHERE THE GRAFTS WERE RELINED WITH NON-MDT STENT GRAFTS. THE PATIENT IS REPORTED AS DOING FINE POST INTERVENTION. PER THE PHYSICIAN THE CAUSE OF THE STENT GRAFT SEPARATION IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 19161845 ↗
• InjuryDec 8, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFT (VNMC4034C200TU) WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED ON UNKNOWN DATE, A FOLLOW UP CT REVEALED A TYPE B DISSECTION WITH A RAPIDLY ENLARGING FALSE LUMEN AND ANEURYSMAL FORMATION IN THE DISTAL THORACIC AORTA, WITH PRESERVED VISCERAL AND LOWER EXTREMITY FLOW. APPROXIMATELY 6 MONTHS POST THE INDEX PROCEDURE, A TEVAR INTERVENTION WAS PREFORMED TO TREAT THE TYPE B AORTIC DISSECTION AND THE RAPIDLY EXPANDING FALSE LUMEN. A DISTAL EXTENSION USING A VALIANT NAVION STENT GRAFT (VNMC3434C182TU) AND 2 TALENT OCCLUDERS WERE SUCCESSFULLY IMPLANTED TO RESOLVE THE DISSECTION. PER THE PHYSICIAN THE CAUSE OF THE TYPE B DISSECTION AND FALSE LUMEN ENLARGEMENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Vascular Dissection

  MAUDE report 18290012 ↗
• DeathJul 18, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM AND FOUR VALIANT NAVION ((B)(6)) STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A ANEURYSM ON (B)(6) 2019. A VALIANT ((B)(6)) STENT GRAFT WAS ALSO IMPLANTED 3 MONTHS LATER AND ANOTHER VALIANT GRAFT (B)(6) SUBSEQUENTLY IMPLANTED APPROXIMATELY 8 MONTHS POST THE INDEX PROCEDURE. IT WAS REPORTED APPROXIMATELY 9 MONTHS POST THE INDEX PROCEDURE FOLLOW UP CT IDENTIFIED A TYPE IIIA ENDOLEAK WAS NOTED AT THE ABDOMINAL AORTIC STENT WHICH EXTENDS SUPERIORLY INTO THE DISTAL THORACIC AORTA. 9.5X7.8CM. CT AT 12 MONTHS SHOWED THERE WAS A PATENT ENDOVASCULAR STENT WHICH EXTENDS FROM THE DISTAL AORTIC ARCH INTO THE INFRARENAL ABDOMINAL AORTA, THERE IS A PERSISTENT LARGE TYPE III EL OF THE ABDOMINAL AORTIC STENT WHICH EXTENDS SUPERIORLY INTO THE DISTAL THORACIC AORTA, STABLE IN SIZE COMPARED TO PREVIOUS IMAGES. 8.4X7.0CM. INTERVENTION WAS THEN PERFORMED WHERE EMBOLIZATION WITH COILING WAS PERFORMED. A CT POST INTERVENTION APPROXIMATELY 16 MONTHS POST THE INDEX PROCEDURE SHOWED A NEW TYPE I ENDOLEAK ORIGINATING AT THE LEVEL OF THE PROXIMAL THORACIC ENDOGRAFT. THE PREVIOUS TYPE III ENDOLEAK WENT FROM 8.5CM TO 9.6CM. EMBOLIZATION WAS PERFORMED

  Patient problems: Cardiac Arrest

  MAUDE report 17340460 ↗
• MalfunctionJun 30, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION AS PART OF THE DISSECT-N STUDY. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE, FOLLOW-UP CT SHOWED A TYPE IB ENDOLEAK AND A MAXIMUM AORTIC DIAMETER OF 42MM. CORELAB REVIEW OF IMAGES DATED (B)(6) 2022 SHOWED NO ENDOLEAK, NO FRACTURE AND NEW AORTIC ENLARGEMENT ALONG THE ENDOGRAFT OF +6.2MM WAS IDENTIFIED. THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm

  MAUDE report 17238925 ↗
• InjuryOct 17, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 66.8MM TAA. IT WAS REPORTED THAT ON A FOLLOW-UP CTA , THERE IS A 11MM ANEURYSM GROWTH IN THE MID DESCENDING THORACIC AORTA OVER A 12 MONTH PERIOD. A PROXIMAL LEAK THAT WAS ALSO IDENTIFIED AND IS THOUGHT TO BE CONTRIBUTING TO THE ANEURYSM GROWTH. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY. THE STENT GRAFT  WAS PLACED IN ACUTE ARCH DISTAL TO THE LEFT SUBCLAVIAN ARTERY. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15613727 ↗
• MalfunctionApr 28, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED TO TREAT A DISSECTION. IT WAS REPORTED THAT, DURING A FOLLOW UP CT, A TYPE IB ENDOLEAK WAS FOUND. PER PHYSICIAN, THE CAUSE OF THE TYPE IB ENDOLEAK IN UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14239065 ↗
• InjuryFeb 23, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC ANEURYSM .  IT WAS REPORTED THE PATIENT RETURNED FOR A FOLLOW-UP CT WHERE A TYPE IA ENDOLEAK WITH DISEASE PROGRESSION WAS OBSERVED. THE PHYSICIAN IMPLANTED PROXIMAL AND DISTAL EXTENSIONS THE NEXT DAY AND THE ENDOLEAK WAS RESOLVED.  AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK CANNOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 13583109 ↗
• InjuryNov 15, 2021Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN THORACIC ENDOVASCULAR PROCEDURE. IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE DURING A REINTERVENTION TO FIX A TYPE IB ENDOLEAK AND TREAT A NEW A SMA ANEURYSM THE PHYSICIAN NOTED THAT THE DISTAL PORTION OF THE NAVION STENTGRAFT APPEARED TO HAVE A STENT RING DETACHED FROM THE FABRIC THE DISTAL PORTION OF THE NAVION STENT GRAFT APPEARED TO HAVE A STENT RING DETACHED FROM THE FABRIC. IT WAS REPORTED THAT THE IB WAS RESOLVED THROUGH DISTAL EXTENSION OF THE NAVION GRAFT.  AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IB ENDOLEAK AND STENT RING DETACHMENT CANNOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm; Insufficient Information

  MAUDE report 12812079 ↗
• InjuryNov 9, 2021Leak/Splash; Leak/Splash

  2 VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE PATIENT DURING AN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SEVERE BACK PAIN . A CT SCAN WAS PERFORMED AND A TYPE 1B ENDOLEAK WAS IDENTIFIED. IT WAS STATED THAT THE PATIENT HAD ACUTE AORTIC SYNDROME. INTERVENTION WAS PERFORMED WHEN THE PATIENT UNDERWENT A 13H LONG PROCEDURE. A NON-MEDTRONIC STENT GRAFT  WAS USED TO RELINE THE STENT. THE ENDOLEAK IS REPORTED TO HAVE RESOLVED. NO CAUSE OF THE ENDOLEAK WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 12778904 ↗
• DeathNov 2, 2021Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A TYPE A DISSECTION. IT WAS REPORTED THAT THE DISSECTION WAS COMPLICATED BY TAMPONADE STATUS POST EMERGENT PERICARDIAL WINDOW. LEFT CAROTID-CAROTID BYPASS, LEFT CAROTID-SUBCLAVIAN BYPASS, THORACIC ENDOVASCULAR AORTIC REPAIR AND FEMORAL-FEMORAL BYPASS WERE PREVIOUSLY PERFORMED ON (B)(6) 2019 TO TREAT ALL FOR COMPLICATIONS OF THE DISSECTION. COMPLETION ANGIOGRAPHY DEMONSTRATING RETAINED PATENCY OF THE RIGHT BRACHIOCEPHALIC ARTERY, AS WELL AS GRAFT ANASTOMOSED LEFT SUBCLAVIAN AND LEFT COMMON CAROTID ARTERIES. THERE IS PERSISTENT, ALBEIT MUCH MORE DELAYED, FILLING OF THE FALSE LUMEN OF THE THORACIC AORTA BOTH PROXIMALLY AND DISTALLY FOLLOWING ENDOVASCULAR REPAIR, WHICH WILL SUBSEQUENTLY BE FOLLOWED WITH SERIAL IMAGING. IT WAS FURTHER REPORTED THAT AN ENDOLEAK TYPE 1A WAS OBSERVED ON A CT SCAN PERFORMED APPROXIMATELY 5 DAYS POST IMPLANT. THE PHYSICIAN REPORTED THAT THE ORIGIN OF HIS PROBLEM IS LIKELY HIS DISTAL ANASTOMOSIS OF HIS ASCENDING AORTIC GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT DIED APPROXIMATELY 13 DAYS POST INDEX PROCEDURE. IT WAS REPORTED PER THE PHYSICIAN

  Patient problems: Insufficient Information

  MAUDE report 12736157 ↗
• InjuryJul 1, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  TWO VALIANT NAVION STENT GRAFT WERE IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY 25 MONTHS POST PROCEDURE, A DISTAL AORTIC DILATATION, GETTING PROGRESSIVELY LARGER WAS OBSERVED. A CT PERFORMED AND A SUSPECTED ENDOLEAK TYPE 1B WAS NOTED. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12098781 ↗