Valiant Navion™ VNMF3731C173TU (UDI 00763000100865)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000100865), received between Apr 12, 2019 and Apr 24, 2025 — classified as 3 deaths, 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE VALIANT NAVION DISTAL STENT GRAFT SEPARATED FROM THE PROXIMAL VALIANT NAVION STENT, AND A TYPE III ENDOLEAK WAS PRESENT IN THE THORACIC AORTA. THE EVENT WAS DISCOVERED ON THE DATE OF COMPUTED TOMOGRAPHY. THE PATIENT WAS INITIALLY TREATED FOR A DISSECTION MEASURING 200MM IN LENGTH. TREATMENT INVOLVED RE-LINING THE EXISTING GRAFTS WITH A 38-34/150 VALIANT CAPTIVIA PROXIMAL GRAFT AND A 38-34/150 VALIANT CAPTIVIA DISTAL GRAFT. THE HEALTHCARE PROFESSIONAL ATTRIBUTED THE CAUSE OF THE EVENT TO ANATOMICAL CHANGES AS THE THORACIC AORTA BULGED OUT ON THE OUTER CURVE, CAUSING THE DISTAL GRAFT TO SLIDE DOWN AND SEPARATE FROM THE PROXIMAL GRAFT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21900289 ↗
• InjuryNov 8, 2024Fracture; Leak/Splash; Detachment of Device or Device Component; Fracture; Leak/Splash; Detachment of Device or Device Component

  THREE VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 65MM THORACIC AORTIC ANEURYSM. AN ENDURANT STENT GRAFT LIMB WAS IMPLANTED 4 YEARS POST THE INDEX PROCEDURE TO EXTEND AN EXISTING NON MEDTRONIC LIMB. IT WAS REPORTED APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE, REVIEW OF CT IMAGING SHOWED THAT THE PROXIMAL VALIANT NAVION GRAFT V NMF3731C173TU APPEARED TO HAVE A STENT FRACTURE WITH A CORRESPONDING TYPE IIIB ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE STENT FRACTURE AND ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 20639016 ↗
• DeathJul 11, 2024Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS (VNMF3731C173TU & VNMC3131C90TU) AND AN ENDURANT II STENT GRAFT SYSTEM WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL ANEURYSM. IT WAS REPORTED APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY AND WAS HOSPITALIZED FOR A STREPTOCOCCUS MITIS BACTERAEMIA INFECTION, WITH POSSIBLE FOCUS OF INFECTION AT THE AORTIC ENDOGRAFT IN THE DESCENDING THORACIC AORTA. DUE TO THE SUSPICION OF GRAFT INFECTION, A THREE-PHASE WHITE BLOOD CELL WAS COMPLETED WHICH DID NOT SHOW ANY ACTIVE INFLAMMATION IN THE GRAFT AREA. ULTIMATELY THE PATIENT WAS DISCHARGED 6 DAYS LATER ON IVAB. FOLLOWING ANOTHER HOSPITALIZATION APPROXIMATELY 1 MONTH LATER, THE PATIENT HAD A REPEAT WBC SCAN WHICH SHOWED SUBTLE UPTAKE AROUND THE GRAFT. THE PATIENT WAS GIVEN A TREATMENT PLAN TO CONTINUE ANTIBIOTIC TREATMENT WITH THE ADDITIONAL ANTIBIOTIC ADDED. THE CAUSE OF THE INFECTION IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Intracranial Hemorrhage; Unspecified Infection

  MAUDE report 19718419 ↗
• InjuryOct 17, 2023Adverse 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 AND ANEURYSM. IT WAS REPORTED THAT A CT TAKEN APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE SHOWED AORTIC ENLARGEMENT. INTERVENTION WAS PERFORMED WHERE TWO VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED. NO CAUSE WAS PROVIDED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Aneurysm

  MAUDE report 17948206 ↗
• MalfunctionOct 13, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT VNMC3434C182TU WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION/ANEURYSM. A LEFT CAROTID TO LSCA BYPASS WAS PERFORMED AND THE VALIANT STENT GRAFT WAS IMPLANTED COVERING THE LSCA TO MID-DESCENDING THORACIC AORTA. 3 DAYS LATER AN ENDURANT BIFURCATE (V29912843) AND LIMBS (V29900390 <(>&<)> V29867319) WERE IMPLANTED TO TREAT AN INFRA-RENAL ABDOMINAL AORTIC ANEURYSM. ONE MONTH POST THE INDEX PROCEDURE, AN ADDITIONAL VALIANT NAVION STENT GRAFT (V08172862), AN ENDURANT BIFURCATE (V29874643) AND ENDURANT LIMB (V29557299) WERE IMPLANTED DURING A DEBRANCHING PROCEDURE OF THE UPPER ABDOMINAL AORTA. A UNITARY STENT GRAFT WITH INDIVIDUAL STENTING OF THE CELIAC, (SMA), AND RIGHT AND LEFT RENAL ARTERIES WAS ALSO PERFORMED. IT WAS REPORTED DURING THE INDEX PROCEDURE, A POST-PROCEDURE ANGIOGRAPHY REVEALED SOME RETROGRADE FLOW INTO FALSE LUMEN FROM THE DISTAL PORTION OF GRAFT. APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT SHOWED PATENT GRAFTS IN THE THORACIC <(>&<)> ABDOMINAL AORTAS BUT DID NOTE ''PERSISTENT MINIMAL OPACIFICATION OF THE NATIVE ANEURYSM SAC AT AND BELOW THE LEVEL OF THE JUNCTION OF THE DESCENDING AORTA STENT G

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17928887 ↗
• InjuryJul 25, 2023Leak/Splash; Leak/Splash

  THREE VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. CORE LAB REVIEW OF CT IMAGES FROM 13 DAYS POST INDEX PROCEDURE REVEALED NON-NAVION TYPE IB ENDOLEAK ON THE SMA BRANCH. REVIEW OF IMAGES TAKEN AT DIFFERENT DATES WITHIN THE THIRD MONTH AFTER THE INDEX PROCEDURE REVEALED THE NEW TYPE IA ENDOLEAK. IMAGING TAKEN EARLIER ON THE 3RD MONTH POST INDEX SHOWED A NEW PROXIMAL DISSECTION. THE MAXIMUM AORTIC DIAMETER WAS NOTED AS 57.7MM , 60.4MM AND 62.1MM THROUGHOUT THIS MONTH. IMAGES AT 4 MONTHS SHOWED A MAXIMUM AORTIC DIAMETER OF 65.3MM AND AORTIC ENLARGEMENT +7.6MM. SEVERAL CTS WERE TAKEN DURING THE 5TH MONTH POST INDEX PROCEDURE. ON THE 8TH DAY OF THE MONTH, CTS REVEALED A TYPE IA ENDOLEAK, A MAXIMUM AORTIC DIAMETER OF 10.3MM AND AORTIC ENLARGEMENT +12.5MM. REVIEW OF IMAGES FROM 2 WEEKS LATER REVEALED AORTIC ENLARGEMENT +11.8MM AND A MAXIMUM AORTIC DIAMETER OF 69.5MM. REVIEW OF IMAGES AT THE END OF THE 5TH MONTH POST INDEX SHOWED A TYPE IA ENDOLEAK, AORTIC ENLARGEMENT OF +15.6MM AND A MAXIMUM AORTIC DIAMETER OF 73.3MM . REVIEW OF CTS AT 6 MONTHS POST INDEX REVEALED AORTIC ENLARGEMENT OF +15.7MM AND MAXIMUM AORTIC DIAMETER OF 73.4MM. NO STENT FRACTURE

  Patient problems: Aneurysm; Vascular Dissection

  MAUDE report 17388277 ↗
• InjuryJun 30, 2023Fracture; Leak/Splash; Detachment of Device or Device Component; Fracture; Leak/Splash; Detachment of Device or Device Component

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA AND DISSECTION .  IT WAS REPORTED CT IMAGING WAS PERFORMED THREE AND A HALF YEARS LATER . CORELAB HAVE REVIEWED THIS IMAGING AND IDENTIFIED AN UNDETERMINED TYPE ENDOLEAK.  A FRACTURE WAS NOTED ON THE STENT GRAFT WITH SN (B)(4). STENT RING ENLARGEMENT WAS ALSO NOTED ON STENT GRAFT WITH (B)(4), STENT RING 4 (+ 4.2) , STENT RING 5 (+7.3), STENT RING 6 (+7.1). NO STENT RING MIGRATION WAS NOTED. THE MAXIMUM AORTIC DIAMETER MEASURED 71.9MM.  NO CAUSE 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 17237612 ↗
• InjuryMar 30, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A RUPTURED TAA. DEBRANCHING WAS ALSO PERFORMED.  IT WAS REPORTED DURING A CTA APPROXIMATELY 46 MONTHS POST IMPLANT,THE PATIENT WAS FOUND TO HAVE AN UNDETERMINED ENDOLEAK THAT EXTENDS FROM AORTIC HIATUS TO THE AORTIC BIFURCATION. THE SIZE OF THE ANEURYSM IS STABLE.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDE AND THE PATIENT WILL BE MONITORED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions; Pseudoaneurysm; Renal Failure

  MAUDE report 16641730 ↗
• InjuryAug 30, 2022Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  A VALIANT NAVION THORACIC STENT GRAFT WAS IMPLANTED FOR THE TREATMENT FOR A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT A CT PERFORMED ABOUT 6 MONTHS LATER IDENTIFIED A TYPE IA ENDOLEAK. 2 DAYS LATER, A SECONDARY PROCEDURE WAS PERFORMED WITH THE INDICATION OF ANEURYSM GROWTH. A SCAN WAS PERFORMED THE FOLLOWING MONTH, AND THE ENDOLEAK HAS RESOLVED. THERE WAS NO OBSERVATIONS NOTED ON THE MOST RECENT SCAN 1 MONTH AGO AS THERE WAS NO ENDOLEAK PRESENT. NO CAUSE WAS PROVIDED. NO ADDITIONAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Chest Pain; Insufficient Information

  MAUDE report 15318448 ↗
• MalfunctionMay 26, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION AS PART OF A PRIOR AORTIC REPAIR REINT ERVENTION . IT WAS REPORTED THE PATIENT RETURNED FOR A FOLLOW-UP CT WHERE A TYPE IB AND TYPE II ENDOLEAK WAS OBSERVED.  NO CAUSE FOR THE TYPE IB AND TYPE II 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 14511508 ↗
• InjuryJul 6, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION ON THE. IT WAS REPORTED ABOUT 7 MONTHS LATER, THE PATIENT HAD BEEN TRANSFERRED FROM ANOTHER HOSPITAL WITH COMPLAINTS OF CHEST PAIN AND SHORTNESS OF BREATH. A CTA PERFORMED DEMONSTRATED A TYPE IB ENDOLEAK. INTERVENTION WAS PERFORMED 4 DAYS LATER, WHERE THE FALSE LUMEN WAS COIL EMBOLIZED. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY. THE SITE ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR PROCEDURE AND POSSIBLY RELATED TO THE DISSECTION UNDER STUDY. THE SPONSOR ASSESSED THE EVENT AS RELATED TO THE STUDY DEVICE AND DISSECTION AND NOT RELATED TO THE PROCEDURE. THE CEC (CLINICAL EVENTS COMMITTEE) ASSESSED THE EVENT AS RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE STUDY PROCEDURE. NO CAUSE OF THE IB ENDOLEAK WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 12120268 ↗
• DeathJul 1, 2020Malposition of Device; Malposition of Device

  A VALIANT STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PATIENT HAD A CHALLENGING LOCATION OF THE ANEURYSM AS IT WAS RIGHT ON THE AORTIC ARCH MAKING IT DIFFICULT TO ADVANCE WIRES AND THE DEVICE INTO THE PLANNED PROXIMAL LANDING ZONE AT THE LCCA. TWO VALIANT NAVION STENT GRAFTS WERE PLACED BUT IT WAS STILL CONSIDERED THAT THEY WEREN'T FAR ENOUGH PROXIMALLY TO OBTAIN A GOOD SEAL. THE PHYSICIAN ATTEMPTED TO SNARE THE DISTAL TIP OF THE WIRE FROM THE GROIN TO CREATE A BETTER ROUTE TO NAVIGATE THE ANATOMY. AFTER SEVERAL ATTEMPTS WITH THE SNARE THEY WERE UNSUCCESSFUL. THE PHYSICIAN THEN PLACED ANOTHER VALIANT NAVION DEVICE PROXIMAL TO THE MOST PROXIMAL DEVICE TO OBTAIN THE SEAL. THERE WERE SEVERAL TIMES WHERE THE INTERVENTIONAL WIRE HAD TO BE REPOSITIONED OVER THE ARCH IN ORDER TO ADVANCE THE DEVICES. IT WAS REPORTED THAT A WEEK POST INDEX PROCEDURE, THE SALES REP CONTACTED THE PHYSICIAN TO ENQUIRE ABOUT THE PATIENT'S CONDITION. THE PHYSICIAN EXPLAINED THAT THE PATIENT SUFFERED AN EMBOLIC STROKE AND DID NOT WAKE FROM THE PROCEDURE AND LATER DIED. AS PER THE PHYSICIAN, THE CA

  Patient problems: Death; Stroke/CVA

  MAUDE report 10218308 ↗
• InjuryDec 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 300MM DIAMETER THORACIC AORTIC DISSECTION,AT THE LEVEL OF THE KOMMERELLS DIVERTICULUM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE PATIENT HAD AN ABERRANT RIGHT SUBCLAVIAN WHICH WAS PLUGGED TO OCCLUDE IT. POST-OPERATIVELY THE PATIENT HAD A COLD RIGHT ARM. IT WAS NOTED THAT THE BRACHIAL ARTERY WAS INJURED AND HAD TO BE REPAIRED. THE PATIENT AWOKE WITH PARALYSIS DISTAL TO T6. A SPINAL DRAIN WAS PLACED AND THE MEAN ARTERIAL PRESSURE WAS ELEVATED. THE PATIENT HAS NOT RECOVERED AT THIS TIME AND HAS NO MOVEMENT BELOW T6. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS ANATOMY RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Paralysis

  MAUDE report 9472511 ↗
• DeathApr 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT TREATMENT OF A RUPTURED THORACIC ANEURYSM. APPROXIMATELY TWO WEEKS LATER, THE PATIENT'S WIFE CALLED TECHNICAL SERVICES TO REPORT THAT THE PATIENT DID NOT SURVIVE THE PROCEDURE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PATIENT'S CONDITION DETERIORATED AND CPR WAS COMMENCED. A RUPTURE OCCURRED BEFORE ANY OF THE DEVICES WERE IMPLANTED AND THE PATIENT EXPIRED POST THE PROCEDURE. AS PER THE PHYSICIAN THE CAUSE OF DEATH WAS NOT DEVICE RELATED.

  Patient problems: Death

  MAUDE report 8508278 ↗
• InjuryApr 12, 2019Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN LENGTH THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS POST IMPLANT, THE PATIENT PRESENTED EMERGENTLY. AN ANGIOGRAM SHOWED THAT THE PATIENT HAS EITHER A TYPE IA OR A TYPE III ENDOLEAK AROUND THE PROXIMAL PORTION OF THE STENT GRAFT. THE PHYSICIAN COILED THE LSA AS TREATMENT, HOWEVER AN ENDOLEAK WAS STILL VISIBLE ON A SUBSEQUENT SCAN. THE CAUSE OF THE EVENT IS UNKNOWN, POSSIBLY DUE TO A TYPE IA OR A TYPE II ENDOLEAK AS PER THE PHYSICIAN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8508178 ↗