Valiant Navion™ VNMF3737C97TURecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000100674), received between Feb 21, 2019 and Jul 19, 2023 — classified as 4 deaths, 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• DeathJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT CORELAB REVIEW OF CT DATED (B)(6) 2020 SHOWED A NEW TYPE IB ENDOLEAK IN VNMC3737C223TU ((B)(6)). THERE WAS NO FRACTURE, NO STENT RING ENLARGEMENT AND NO STENT RING MIGRATION OBSERVED. THE MAXIMUM AORTIC DIAMETER WAS 62.1MM. VNMF3737C97TU ((B)(6)) WAS NON-EVALUABLE FOR FRACTURE DUE TO DEVICE OVERLAPS AND A SIGNIFICANT AMOUNT OF CALCIFICATION. IT WAS REPORTED THE PATIENT EXPIRED APPROXIMATELY ONE MONTH POST THE INDEX PROCEDURE DUE TO AN UNKNOWN CAUSE. THE CAUSE OF THE ENDOLEAK AND DEATH IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17349557 ↗
• MalfunctionFeb 28, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED TAA .  IT WAS REPORTED THAT FROM A CT, CORELAB OBSERVED STENT RING MIGRATION OF + 2.8MM. NO STENT RING ENLARGEMENT, ENDOLEAKS OR FRACTURES WERE NOTED. THE MAXIMUM AORTIC DIAMETER WAS 49.5MM.  THE PATIENT DIED ALMOST THREE YEARS LATER FROM A NON AORTIC RELATED CAUSE. THE DEVICE REMAINED IN THE PATIENT.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS DECEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16451745 ↗
• MalfunctionFeb 15, 2023Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA WAS IMPLANTED DURING THE TREATMENT OF A THORACIC ANEURYSM OF AN UNKNOWN SIZE. IT WAS REPORTED THAT ON  FOLLOW-UP CT FROM APPROXIMATELY 29MONTHS POST INDEX PROCEDURE, THE PATIENT WAS FOUND TO HAVE AORTIC ENLARGEMENT. CORELAB REVIEW OF IMAGES FROM THE SAME DATE IDENTIFIED A TYPE IA ENDOLEAK ON VNMF3737C97TU (B)(4) AND A MAXIMUM AORTIC DIAMETER OF 87.4MM. THERE WAS NO STENT RING ENLARGEMENT OF STENT RING MIGRATION OBSERVED ON THE CTS. IMAGES WERE NOT EVALUATED FOR FRACTURE DUE TO DEVICE OVERLAPS. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm

  MAUDE report 16377278 ↗
• MalfunctionJan 24, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZE TAA. THE PATIENT WAS NOTED TO HAVE NON MDT STENTS IN THE SMA , RENAL ARTERY AND CELIAC ARTERY ALL DISTAL TO THE NAVION. IT WAS REPORTED ON THE DATE OF A CT TWO MONTHS LATER, AN UNDETERMINED ENDOLEAK WAS NOTED. NO TREATMENT WAS PERFORMED .  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16231652 ↗
• InjuryAug 12, 2022Leak/Splash; Material Deformation; Material Split, Cut or Torn; Leak/Splash; Material Deformation; Material Split, Cut or Torn

  A VALIANT NAVION WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 50MM TAA . IT WAS REPORTED THE PATIENT PRESENTED WITH BACK PAIN. A CT CARRIED OUT ON THE SAME DATE SHOWED BOTTOM EXPANSION AND A TYPE IB ENDOLEAK. INTERVENTION WAS PERFORMED THE NEXT DAY WHERE A NON-MEDTRONIC STENT GRAFT WAS IMPLANTED AND THE ENDOLEAK RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO DEVICE FAILURE. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 15215956 ↗
• MalfunctionJun 21, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION THORACIC STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A PENETRATING AORTIC ULCER ON (B)(6) 2020.  IT WAS REPORTED APPROXIMATELY 14 MONTHS POST THE INDEX PROCEDURE FOLLOW UP CT IDENTIFIED A TYPE LB ENDOLEAK. NO CAUSE OF THE EVENT PER THE PHYSICIAN WAS PROVIDED. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754627 ↗
• DeathJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A PAU AND SACCULAR THORACIC AORTIC ANEURYSM.  IT WAS REPORTED 5 WEEKS POST THE INDEX PROCEDURE THE PATIENT HAD A FOLLOW UP CT WHERE AORTIC ENLARGEMENT WAS OBSERVED. THE PATIENT EXPIRED 7 WEEKS POST THE INDEX PROCEDURE DUE TO STENT GRAFT INFECTION/ SEPSIS.  NO CAUSE OF THE STENT GRAFT INFECTION/ SEPSIS AS PER THE PHYSICIAN WAS PROVIDED. THE STENT GRAFT WAS NOT EXPLANTED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Aneurysm; Sepsis; Unspecified Infection

  MAUDE report 14693189 ↗
• InjuryMar 10, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE THORACIC DEVICES WERE IMPLANTED IN THE ABDOMINAL AORTA DUE TO PATIENT'S ANATOMY. IT IS NOTED THE PATIENT PRESENTLY HAS A 60MM AAA. THE PROXIMAL NECK DIAMETER AT THE RIGHT RENAL IS NOTED AS 28-32MM. THE PATIENT IS NOTED TO HAVE A HOSTILE NECK (SHORT, WIDE, ANGLED). IT WAS REPORTED A CT IDENTIFIED A TYPE IA ENDOLEAK. THERE IS 20MM OF AORTA FROM THE LOWEST LEFT RENAL ARTERY TO THE TOP OF THE NAVION GRAFT. AN INTERVENTION WAS CARRIED OUT AND THE ENDOLEAK HAS BEEN RESOLVED WITH THE IMPLANT OF A VAMF3838C100TU. AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK IS DUE TO THE PATIENT'S OWN ANATOMY AS A RESULT OF THE ANGLE OF THE PROXIMAL LANDING ZONE.  NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 13719835 ↗
• DeathOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE EMERGENT ENDOVASCULAR TREATMENT OF A TYPE A AORTIC DISSECTION FROM THE ROOT TO ASCENDING AORTA. IT WAS REPORTED POST THE INDEX PROCEDURE THE PATIENT WAS PLACED ON ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) AND THEN WENT INTO CARDIAC ARREST. THE PATIENT HAD A DNR AS ADVISED BY THE FAMILY AND EXPIRED ON THE (B)(6) 2019. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Myocardial Infarction; Pain

  MAUDE report 12638286 ↗
• InjuryAug 9, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED FOR A UNKNOWN SIZE THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT A CT WAS PERFORMED APPROXIMATELY 19 MONTHS POST INDEX PROCEDURE, WHERE EVIDENCES OF ENDOLEAK TYPE 3 WAS OBSERVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 12293954 ↗
• InjuryOct 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 1 YEARS POST THE INDEX PROCEDURE, CT SHOWED A TYPE IA ENDOLEAK. INTERVENTION WAS COMPLETED WITH A LEFT CAROTID TO LEFT SUBCLAVIAN BYPASS AND A FURTHER TEVAR PROCEDURE WAS ALSO PERFORMED TO RESOLVE THE EVENT. A VNMF3737C97TU WAS DEPLOYED DISTAL TO THE LEFT CAROTID ARTERY AND VNMF4040C103TU WAS THEN USED TO BRIDGE THE 37 X 37 X 97. COILING OF THE ORIGIN OF THE LEFT SUBCLAVIAN ARTERY WAS COMPLETED DURING THE INDEX PROCEDURE. IT WAS REPORTED POST THE REINTERVENTION PROCEDURE THE PATIENT HAD SEVERAL BLOOD PRESSURE RELATED ISSUES AND HAD SUFFERED A STROKE. THE PATIENT WAS TRANSFERRED TO IR WHERE THE ORIGIN OF THE LEFT CAROTID ARTERY WAS STENTED. SEVERAL ANGIOGRAMS SHOWED NO OBVIOUS SIGNS OF INTERCRANIAL THROMBUS. PER THE PHYSICIAN THE CAUSE OF THE LOSS OF SEAL IS UNDETERMINED. THE CAUSE OF THE STROKE WAS RELATED TO UNSTABLE BLOOD PRESSURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Stroke/CVA

  MAUDE report 9178268 ↗
• MalfunctionFeb 26, 2019Activation, Positioning or Separation Problem; Device Damaged by Another Device; Activation, Positioning or Separation Problem; Device Damaged by Another Device

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 64MM AN INFRA-RENAL ANEURYSM IN CONJUNCTION WITH A NON MDT DEVICE. IT WAS NOTED THE PATIENT HAD SEVERELY DISEASED BILATERAL ILIACS' THROUGHOUT. IT WAS REPORTED DURING THE INDEX PROCEDURE THE RIGHT ILIAC WAS PRE-DILATED WITH NON MDT 7 AND 8 MM BALLOONS. AFTER DEPLOYMENT OF THE NON MDT DEVICE THE PHYSICIAN ATTEMPTED TO ADVANCE THE NAVION DEVICE (B)(4). THE DEVICE WOULD NOT TRACK UP SO THE ILIAC WAS DILATED AGAIN WITH AN 8MM BALLOON AND ALTHOUGH A TIGHT FIT THE DEVICE DID TRACK. AFTER DEPLOYMENT OF THE GRAFT BUT BEFORE THE RELEASE OF THE TIP CAPTURE THE PHYSICIAN FELT A POP AND AT THIS POINT A RAPID DECREASE IN THE PATIENT'S BLOOD PRESSURE WAS NOTED. THE PROXIMAL BARE SPRINGS WERE DEPLOYED HOWEVER UPON REMOVAL OF THE DELIVERY SYSTEM SOME OF THE PATIENT'S BLOOD VESSEL WERE OBSERVED TO BE ATTACHED TO THE DELIVERY SYSTEM. AN INTRA-OPERATIVE ARTERIOGRAM WAS PERFORMED AND A RUPTURE AT THE PATIENTS RIGHT EXTERNAL ILIAC WAS OBSERVED. MULTIPLE COVERED STENTS WERE USED IN AN ATTEMPT TO REPAIR THE ARTERY UNSUCCESSFULLY AND THE PHYSICIAN ELECTED TO CONVERT TO AN OPEN REPAIR OF THE RIGHT ILIAC. LIGATION OF THE N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8369968 ↗
• DeathFeb 21, 2019Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A >100MM RUPTURED THORACIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE IT WAS NOTED THE PATIENT HAD AN EXTREMELY HOSTILE DISTAL SEAL ZONE. THE CELIAC WAS COVERED AND THE DEVICE WAS ANCHORED BUT A PERSISTENT TYPE IB ENDOLEAK WAS VISIBLE. THE PHYSICIAN ELECTED TO IMPLANT COILS INTO SAC TO INDUCE THROMBOSIS IN THE RUPTURED SAC. THE GRAFT WAS EXTENDED LOWER TO COVER SMA AND RENALS HOWEVER A SMALL TYPE IB ENDOLEAK REMAINED AT THE END OF THE PROCEDURE. IT WAS REPORTED THE PATIENT EXPIRED APPROXIMATELY 2 WEEKS POST THE INDEX PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE TYPE IB ENDOLEAK WAS ANATOMY RELATED DUE TO HOSTILE DISTAL SEAL ZONE. THE CAUSE OF DEATH WAS DUE TO A RUPTURED THORACIC AND ABDOMINAL AORTIC ARTERY.

  Patient problems: Death; Rupture

  MAUDE report 8357448 ↗