Valiant Navion™ VNMC3131C90TU (UDI 00763000100971)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000100971), received between Jul 3, 2020 and Oct 6, 2023 — classified as 2 deaths, 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• DeathOct 6, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. ADDITIONALLY, 7 ENDURANT STENT GRAFTS WERE ALSO IMPLANTED DURING THE PROCEDURE. THE VALIANT NAVION STENTS (B)(6) AND (B)(6) WERE IMPLANTED IN THE THORACIC AORTA, WITH THE SECOND DEVICE OVERLAPPING AT PROXIMAL END OF THE FIRST TO ENSURE A MORE SECURE SEAL. ENDO-DEBRANCHING USING AN ENDURANT STENT GRAFT IN THE PROXIMAL ABDOMINAL AORTA WAS A MODIFIED ENDURANT UNITARY GRAFT; IT WAS EXTENDED INTO EACH OF THE CELIAC, SMA, L <(>&<)> R RENAL ARTERIES AND LINED WITH NON MDT SELF-EXPANDING STENTS; IT WAS EXTENDED INTO DISTAL ABDOMINAL AORTA WITH 16X20X124 ENDURANT IIS STENT GRAFTS X2 (WITH THE SECOND OVERLAPPING AT THE PROXIMAL END OF THE FIRST FOR BETTER SEAL/COVERAGE) IT WAS REPORTED DURING THE INDEX PROCEDURE A TYPE IV ENDOLEAK (UNKNOWN WHICH DEVICE) WAS DETECTED. FOLLOWING THE INDEX PROCEDURE, A FOLLOW UP CT SCAN REVEALED AN UNKNOWN ENDOLEAK IN THE THORACIC AORTA, ALONG THE RIGHT POSTEROLATERAL MARGIN OF THE VALIANT NAVION GRAFT. THE ENDOLEAK WAS OBSERVED AT THE SITE WHERE THE COMPONENTS OVERLAPPED AT THE DIAPHRAGMATIC HIATUS. POST THE PROCEDURE, CTA FOR CONCERN FOR MESENTERIC ISCH

  Patient problems: Insufficient Information; Ischemia; Stroke/CVA

  MAUDE report 17884891 ↗
• MalfunctionAug 30, 2023Fracture; Leak/Splash; Fracture; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR REINTERVENTION FOR A PRIOR AORTIC REPAIR. IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE FOLLOW-UP CT SHOWED A SUSPECTED STENT GRAFT FRACTURE  NO CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm expansion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17649883 ↗
• MalfunctionJul 20, 2023Leak/Splash; Leak/Splash

  THREE VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. CORE LAB REVIEW OF CT IMAGING FROM (B)(6) 2021 IDENTIFIED A NEW TYPE IB ENDOLEAK ON VNMC3131C90TU (B)(6). THE MAX AORTIC DIAMETER WAS NOTED AS 39MM. THE IMAGING WAS NOTED AS NON EVALUABLE (NE) FOR STENT FRACTURE, STENT RING ENLARGEMENT AND STENT RING MIGRATION. NO AORTIC ENLARGEMENT WAS OBSERVED. CORE LAB REVEW OF CT IMAGING FROM (B)(6) 2022 SHOWED A PERSISTENT TYPE IB ENDOLEAK ON VNMC3131C90TU (B)(6) THE MAX AORTIC DIAMETER WAS NOTED AS 39MM. THE IMAGING WAS NOTED AS NON EVALUABLE FOR STENT FRACTURE, STENT RING ENLARGEMENT AND STENT RING MIGRATION. NO AORTIC ENLARGEMENT WAS OBSERVED. CORE LAB REVIEW OF CT IMAGING FROM (B)(6) 2022 SHOWED A PERSISTENT TYPE IB ENDOLEAK ON VNMC3131C90TU (B)(6). THE MAX AORTIC DIAMETER WAS NOTED AS NON EVALUABLE. THE IMAGING WAS NOTED AS NON EVALUABLE FOR STENT FRACTURE, STENT RING ENLARGEMENT, STENT RING MIGRATION AND AORTIC ENLARGEMENT. SOME MEASUREMENTS WERE NOTED AS NE DUE TO SIGNIFICANT ARTIFACT PRESENCE AND DEVICE OVERLAPS; AND THE IMAGING FROM (B)(6) 2022 DID NOT INCLUDE THE ENTIRE TREATED REGION. THE CAUSE OF THE TYPE IB ENDOLEAK IS UNDETERMINED. NO ADDIT

  Patient problems: Aneurysm

  MAUDE report 17359753 ↗
• InjuryDec 6, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION SN (B)(4)  STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A ASCENDING AORTIC ANEURYSM AND SUBSEQUENT TOTAL ARCH REPAIR WITH FROZEN ELEPHANT TRUCK . THE PATIENT THEN HAD ANOTHER VALIANT NAVION SN (B)(4)  IMPLANTED 1 YEAR AND 5 MONTHS LATER AS AN EXTENSION TEVAR.  AT THE 1 MONTH FOLLOW-UP FOLLOWING THE EXTENSION, THE PATIENT WAS NOTED TO HAVE A DISSECTION JUST DISTAL TO THE LAST COVERED STENT. INTERVENTION WAS PERFORMED AND A 3RD VALIANT NAVION SN (B)(4) WAS IMPLANTED TO COVER THE EXTENSION.  CORELAB HAVE REVIEWED IMAGING DATED THE 14TH OF MAY 2019, AND OBSERVED A TYPE IB ENDOLEAK ON THE STENT GRAFT (B)(4). NO FRACTURE, STENT RING ENLARGEMENT OR MIGRATION WERE NOTED.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 15922622 ↗
• InjuryNov 18, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A DESCENDING  RUPTURED  TAA .  IT WAS REPORTED THE PATIENT PRESENTED FOR FOLLOW-UP, WHERE A CT WAS PERFORMED. FROM REVIEW OF THE CT, IT WAS NOTED  THE SIZE OF ANEURYSM HAS DECREASED SINCE THE DAY AFTER THE IMPLANT, BUT THERE IS PERSISTENT CONTRAST ENHANCEMENT AT THE RIGHT LATERAL ASPECT SUSPICIOUS FOR ENDOLEAK. SOURCE IS NOT DIRECTLY SEEN BUT LOCATION IN THE PERIPHERY OF ANEURYSM AND DISTANCE FROM THE STENT MIGHT BE A TYPE II LEAK, SAME LOCATION AS PREVIOUS CT.  NO CAUSE WAS THIS ENDOLEAK WAS REPORTED.  NO ADDITIONALCLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 15823157 ↗
• MalfunctionJul 18, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A PENETRATING AORTIC ULCER (PAU). IT WAS REPORTED THAT CORELAB REVIEW OF CT SCANS FROM APPROXIMATELY 2 YEARS AND 5 MONTHS POST INDEX PROCEDURE IDENTIFIED THE PRESENCE OF A TYPE IA ENDOLEAK ON THE DEVICE VNMC3131C90TU (SN (B)(4)). THERE WAS NO STENT RING ENLARGEMENT, DETACHMENT/DISPLACEMENT , FRACTURE OR AORTIC ENLARGEMENT DETECTED. NO CAUSE OF THE ENDOLEAK AS PER THE PHYSICIAN WAS PROVIDED. AS PER THE SITE THE CAUSE OF DEATH WAS NOT AORTIC-RELATED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT EXPIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15041563 ↗
• MalfunctionJun 28, 2022Fracture; Leak/Splash; Fracture; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE CORE LAB REVIEW OF CT IMAGING( 2 YEARS POST THE INDEX PROCEDURE) IDENTIFIED AN UNKNOWN TYPE ENDOLEAK AND MULTIPLE STENT FRACTURES. THE CAUSE OF THE ENDOLEAK AND FRACTURES ARE UNDETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14841671 ↗
• DeathJun 2, 2022Leak/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  FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM OF AN UNKNOWN SIZE.  IT WAS REPORTED DURING A POST-OP CT 2 DAYS LATER, A LARGE TYPE II ENDOLEAK WAS NOTED AT THE LEVEL OF THE PSEUDOANEURYSM,  PERSISTENT LARGE PSEUDOANEURYSM ARISING FROM THE SUPERCELIAC AORTA MEASURING 43MMX28MM. 2 DAYS LATER, THE PHYSICIAN CARRIED OUT A REPAIR  OF THE THORACOABDOMINAL AORTIC ANEURYSM. THROMBECTOMY OF AX-BIFEM, EXPLANTATION OF ENDOGRAFT, AND THROMBO-SMA BYPASS WITH 12MM NON-MDT SURGICAL GRAFT. THE PATIENT EXPIRED THE NEXT DAY. AS PER THE PHYSICIAN THE CAUSE OF DEATH WAS DUE TO SEPSIS AND MULTI-ORGAN FAILURE FROM INFECTION THAT STARTED AFTER INITIAL SURGERY . NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

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

  MAUDE report 14572077 ↗
• MalfunctionFeb 14, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC DISSECTION .  IT WAS REPORTED THE PATIENT HAD A CT WHICH SHOWED THE PRESENCE OF A TYPE IB ENDOLEAK. A FOLLOW-UP CT PERFORMED ABOUT 6 MONTHS LATER SHOWED THE TYPE IB ENDOLEAK WAS STILL PRESENT. NO CAUSE FOR THE TYPE IB ENDOLEAK AS PER THE PHYSICIAN HAS BEEN PROVIDED.  NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13522810 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE ON THE (B)(6) 2019. IT WAS REPORTED THAT ON THE (B)(6) 2021, THE PATIENT RETURNED FOR A FOLLOW-UP WHERE A DISTAL PSEUDOANEURYSM WITH A POSSIBLE INFECTION WAS OBSERVED. THE EVENT WAS TREATED ON THE NEXT DAY WITH A 32X28X150 VALIANT CAPTIVIA IMPLANTED. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Pseudoaneurysm; Unspecified Infection

  MAUDE report 12233078 ↗
• InjuryAug 6, 2020Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT ON CT, APPROXIMATELY 09 MONTHS POST INDEX PROCEDURE, IT WAS OBSERVED THAT THE TWO STENT GRAFTS HAD SEPARATED AND WERE RELINED WITH ANOTHER VALIANT NAVION THE NEXT DAY. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury

  MAUDE report 10372417 ↗
• InjuryJul 3, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AN VALIANT NAVION STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF THORACIC AORTIC ANEURYSM AND TO TREAT SECONDARY KNOWN CHRONIC 230MM DISSECTION OF THE DESCENDING THORACIC AORTA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE LANDING AT THE INNOMINATE ARTERY IN A BOVINE ARCH. THE DILATED AREA WAS LOCATED JUST AT THE TURN OF THE ARCH DISTAL TO THE LEFT SUBCLAVIAN ARTERY (LSA). THE PATIENT HAD LEFT SUBCLAVIAN ARTERY (LSA) -LEFT COMMON CAROTID ARTERY (LCCA) BYPASS DONE THE DAY PREVIOUSLY. THE PLAN WAS TO COVER THE LEFT SUBCLAVIAN ARTERY AND LAND PROXIMAL TO THE INNOMINATE ARTERY. IT WAS STATED THAT THE MEAN BLOOD PRESSURE DURING DEPLOYMENT WAS 88MMHG. IT WAS SUGGESTED TO THE PHYSICIAN TO DECREASE THIS DURING THE DEPLOYMENT BUT IT WAS NOT DECREASED. THE STENT GRAFT DELIVERY AND PLACEMENT WENT AS PLANNED UP UNTIL THE TIP RELEASE WAS ACTIVATED AND THE GRAFT THEN DEPLOYED 2CM DISTAL TO INTENDED LANDING ZONE AND IN THE DILATED PORTION OF THE ARCH. THE PHYSICIAN WAS UNHAPPY WITH THE POSITION OF THE STENT GRAFT AND USED AN NON-MEDTRONIC BALLOON TO INFLATE WITHIN THE STENT GRAFT AND MOVE THE STENT GRAFT DISTALLY BEYOND THE

  Patient problems: Injury

  MAUDE report 10229297 ↗