Valiant Navion™ VNMC4040C175TU (UDI 00763000101107)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000101107), received between Jun 18, 2019 and Oct 29, 2024 — classified as 4 deaths, 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2024Leak/Splash; Leak/Splash

  TWO VALIANT CAPTIVIA STENT GRAFTS AND ONE VALIANT NAVION STENT GRAFT WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM. SEVEN MONTHS LATER, A SECONDARY PROCEDURE WAS PERFORMED TO TREAT A TYPE IA ENDOLEAK. IT WAS REPORTED APPROXIMATELY 5 YEARS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE PHYSICIAN¿S OFFICE AND, ALTHOUGH FEELING WELL, A CT SCAN REVEALED AN INCREASE IN THE THORACOABDOMINAL AORTIC ANEURYSM (TAAA), ALONG WITH A TYPE IB ENDOLEAK AND DISEASE PROGRESSION. INTERVENTION WAS PERFORMED 21 DAYS POST FOLLOW UP, AN ADDITIONAL VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED TO RESOLVE THE TYPE IB ENDOLEAK AND TAAA PROGRESSION. THE SITE ASSESSED THE TAA PROGRESSION AND ENDOLEAK AS RELATED TO THE UNDERLYING DISEASE AND NOT RELATED TO THE STUDY DEVICE OR INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 20555232 ↗
• InjuryJan 26, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A TYPE IA ENDOLEAK. LEFT CAROTID SUBCLAVIAN BYPASS AND LEFT SUBCLAVIAN ARTERY LASER FENESTRATION WAS ALSO COMPLETED. IT WAS NOTED THE PATIENT PREVIOUSLY HAD A THORACO-ABDOMINAL BRANCHING WITH INTERVAL STENTING AND LAPAROTOMY RESECTION AAA 4 YEARS PREVIOUS AND AN ASCENDING HEMIARCH TRANSVERSE ARCH WITH FROZEN ELEPHANT TRUNK 1 YEAR PREVIOUS. IT WAS REPORTED APPROXIMATLEY 4 MONTHS POS THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY COMPLAINING OF SEVERAL DAYS OF PROGRESSIVE CHEST PAIN. SUBSEQUENT IMAGING CONFIRMED NEW EVIDENCE OF A TYPE III ENDOLEAK IN THE MID THORACIC AORTIC SEGMENT WITH NOTABLE RADIOGRAPHIC ANEURYSM SAC EXPANSION IN EXCESS OF 6 MM. THORACIC ENDOVASCULAR REPAIR WITH AN ADDITIONAL VALIANT NAVION (40X20X218MM) WAS COMPLETED ON THE DATE OF PRESENTATION. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETERMINED . NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Chest Pain

  MAUDE report 16246123 ↗
• InjuryJan 13, 2023Leak/Splash; Material Deformation; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Material Deformation; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 66.8 THORACIC AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 18 YEARS POST THE INDEX PROCEDURE FOLLOW UP CT IDENTIFIED A NEW LARGE TYPE IIIB ENDOLEAK DUE TO A FABRIC TEAR AND AORTIC ENLARGEMENT FROM 53MM TO 56MM. INTERVENTION WAS COMPLETED. THE THORACIC ENDOGRAFT CONTAINING THE ENDOLEAK WAS EXPLANTED AND 2 NON MDT GRAFTS WERE IMPLANTED IN THE RIGHT SIDE OF THE AORTA. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS DEVICE RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

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

  MAUDE report 16156405 ↗
• MalfunctionJan 9, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN LENGTH DISSECTION ON THE (B)(6) 2019.  IT WAS REPORTED THAT CORELAB HAVE REVIEWED CT IMAGING TAKEN 10 MONTHS LATER, AND IDENTIFIED A TYPE IB ENDOLEAK ON THE STENT GRAFT (B)(4). LOSS OF SEAL AT DISTAL END OF (B)(4) INDICATES A TYPE IB ENDOLEAK (EVEN THOUGH THERE IS NO CONTRAST ABOVE THE FABRIC LEVEL). NO FRACTURE, STENT RING ENLARGEMENT/MIGRATION WERE IDENTIFIED. AORTIC ENLARGEMENT OF +7.4MM WAS NOTED WHEN COMPARED TO PREVIOUS IMAGING FROM A MONTH POST THE IMPLANT. THE MAXIMUM AORTIC DIAMETER WAS 53.3MM.  CT IMAGING TAKEN A MONTH POST THE INITIAL IMAGING WAS REVIEWED BY CORELAB ALSO. THE PERSISTENT IB ENDOLEAK  WAS OBSERVED AGAIN ON THE STENT GRAFT (B)(4). NO FRACTURE/ STENT RING ENLARGEMENT OR MIGRATION WERE NOTED. THE AORTIC ENLARGEMENT HAD INCREASED TO +8.9MM AND THE MAXIMUM AORTIC DIAMETER WAS 54.8MM.  NO CAUSE WAS REPORTED. IT WAS REPORTED THE PATIENT EXPIRED THE FOLLOWING YEAR DUE TO A NON AORTIC RELATED CAUSE.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16121096 ↗
• InjuryDec 6, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN LENGTH DISSECTION ON (B)(6) 2020.  IT WAS REPORTED THAT CORE LAB REVIEW OF CT IMAGING FROM (B)(6) 2020 IDENTIFIED A TYPE IA ENDOLEAK. NO STENT FRACTURE, STENT RING ENLARGEMENT OR STENT RING MIGRATION WAS OBSERVED. THE IMAGING WAS NOTED AS N/A FOR AORTIC ENLARGEMENT. NO CAUSE WAS PROVIDED.  NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 15922513 ↗
• InjuryFeb 23, 2022Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC ANEURYSM . IT WAS REPORTED THE PATIENT RETURNED FOR A 6-MONTH FOLLOW-UP CT WHERE AN ENDOLEAK AT MID AORTIC SAC WAS OBSERVED. TWO DAYS LATER THE PATIENT UNDERWENT A LEFT RENAL ANGIOGRAM SHOWING THE GRAFT HAD BECOME DISLODGED FROM THE LEFT RENAL ARTERY LEAVING BEHIND THE SELF EXPANDING STENT SO A TYPE IC ENDOLEAK WAS NOTED. THE PHYSICIAN IMPLANTED A NON-MDT RENAL STENT INTO THE LEFT RENAL ARTERY 2 DAYS LATER. COMPLETION ANGIOGRAM SHOWED GOOD SEAL AND GOOD FLOW TO THE REMAINING LEFT KIDNEY. IT WAS NOTED THAT AT THE INITIAL INDEX PROCEDURE, THE BRIDGING STENT WAS PLACED AN INADEQUATE DISTANCE INTO LEFT RENAL ARTERY TO TRY AND SAVE LOWER POLE BRANCH (PATIENT HAS 1 WORKING KIDNEY). THIS DID NOT HAVE ENOUGH PURCHASE TO SECURE GRAFT INTO PLACE AND STENT GRAFT BECAME DISLODGED LEAVING BEHIND THE SELF EXPANDING STENT AND TYPE IC ENDOLEAK. AT THE RE-INTERVENTION PROCEDURE , THE PHYSICIAN SACRIFICED THE LOWER POLE BRANCH AND WAS ABLE TO OBTAIN GOOD SEAL AND DISTANCE WITHIN LEFT RENAL ARTERY. FOLLOW UP APPOINTMENT ON POST-OPERATIVE DAY 197 SHOWED THE STENT TO BE IN GOOD POSITION. I

  Patient problems: Insufficient Information; Renal Failure

  MAUDE report 13583246 ↗
• DeathFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC ANEURYSM .  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY TO THE EMERGENCY DEPARTMENT A YEAR LATER WITH ABDOMINAL WALL PAIN, BACK PAIN WITH DIARRHEA FOR 3 DAYS, BILATERAL CHEST PAIN, DIAPHORESIS, SHORTNESS OF BREATH AND SEVERE WEAKNESS WITH A FALL AND INABILITY TO GET UP. IT WAS FOUND THE PATIENT HAD PERICARDIAL EFFUSION. THERE WAS NO EVIDENCE OF DISSECTION AND THE PATIENT HAS A KNOWN ASCENDING AORTIC ANEURYSM WHICH APPEARED TO BE ENLARGING IN SIZE. THE PATIENT WAS TREATED WITH MEDICATION. THE PATIENT HAS A PALLIATIVE CARE CONSULT THE NEXT DAY  DUE TO SIGNIFICANT RISK OF MORTALITY (10-15% AT 30 DAYS) IF MOVE TOWARDS REPAIR OF ENLARGING ASCENDING AORTIC ANEURYSM. THE PATIENT DECIDED AGAINST TREATMENT DUE TO THE RISK OF DIALYSIS. THE PATIENT EXPIRED THE NEXT DAY. AS PER THE PHYSICIAN THE CAUSE OF DEATH WAS AS A RESULT OF LARGE AORTIC ANEURYSM AND PERICARDIAL EFFUSION. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Abdominal Pain; Aneurysm; Diaphoresis; Diarrhea; Dyspnea; Muscle Weakness/Atrophy; Pericardial Effusion; Thrombosis/Thrombus

  MAUDE report 13583011 ↗
• InjuryOct 13, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN AN UNKNOWN  ENDOVASCULAR TREATMENT.  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT WAS BEING SEEN AT ANOTHER FACILITY AND HAD UNDERGONE A REVISION PROCEDURE DUE TO REPORTED DISTAL STENT MIGRATION. NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12624103 ↗
• DeathJul 28, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT 2 AND A HALF YEARS LATER, A CT IMAGES WERE REVIEWED, WHERE A ENDOLEAK TYPE 1B WAS NOTED. IT WAS REPORTED THE TYPE IB ENDOLEAK APPEARED TO TOUCH BOTH OF THE IMPLANTED DEVICES. IT WAS REPORTED AN ADDITIONAL TWO SURGICAL REPAIR PROCEDURES WERE PERFORMED AND THE PATIENT EXPIRED DURING THE SECOND PROCEDURE. IT WAS REPORTED THE CAUSE OF DEATH WAS AN INTRA-OPERATIVE RUPTURED ANEURYSM. IT WAS NOTED THAT DURING THE FIRST INTERVENTION PROCEDURE, AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED ALONG WITH A VALIANT NAVION STENT GRAFT. THE PATIENT REPORTEDLY EXPIRED DURING THE SECOND PROCEDURE WHERE TWO FURTHER STENT GRAFTS HAD BEEN IMPLANTED, A ENDURANT LIMB AND A VALIANT NAVION STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information; Rupture

  MAUDE report 12238517 ↗
• MalfunctionApr 15, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED A CT PERFORMED APPROX. 2 YEARS POST IMPLANT, IDENTIFIED TYPE IA AND IB ENDOLEAKS. INTERVENTION WAS PERFORMED ON THE SAME DATE WHERE A NAVION STENT GRAFT WAS IMPLANTED. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

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

  MAUDE report 11671526 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 56 MM ABDOMINAL AORTIC ANEURYSM. A VALIANT NAVION STENT GRAFT SYSTEM WAS ALSO IMPLANTED DURING THE PROCEDURE FOR TREATMENT OF A THORACIC TYPE IIIB ENDOLEAK. A TALENT STENT GRAFT SYSTEM WAS PREVIOUSLY IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM AND A BYPASS TO THE VISCERAL VESSELS WAS ALSO REPORTED TO HAVE BEEN CARRIED OUT. A VALIANT CAPTIVIA STENT GRAFT WAS ALSO IMPLANTED IN THE PATIENT FOR TREATMENT OF A TYPE IB ENDOLEAK. THE TYPE IIIB ENDOLEAK ORIGINATED FROM THE PREVIOUSLY IMPLANTED VALIANT CAPTIVIA AND TALENT STENT GRAFT SYSTEMS. IT WAS REPORTED THE ENDURANT IIS SYSTEM WAS IMPLANTED INFRARENALLY AND THEN THE NAVION VALIANT SYSTEM WAS IMPLANTED. IT WAS REPORTED THAT THE PROCEDURE WENT WELL, HOWEVER, TWO HOURS POST-PROCEDURE IT WAS REPORTED THAT THE PATIENT WAS PARALYZED. AS PER THE PHYSICIAN, THE CAUSE OF THE PARALYSIS WAS DUE TO THE PATIENT¿S ANATOMY. IT WAS REPORTED THAT THE CSF DRAIN WAS IMPLANTED PRIOR TO THE PROCEDURE BUT DUE TO THE LENGTH OF THE COVERAGE REQUIRED (FROM THE LSA TO COMMON ILIAC ARTERIES BILATERALLY), THE PATIENT BECAME P

  Patient problems: Paralysis

  MAUDE report 9007193 ↗
• DeathSep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THE ORIGINAL PLAN FOR TREATMENT WAS TO IMPLANT THE VALIANT NAVION STENT GRAFT AND TO REPAIR THE PATIENT¿S ABDOMINAL ANEURYSM AT A LATER DATE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE AFTER THE VALIANT NAVION WAS DEPLOYED A DROP IN THE PATIENT¿S BLOOD PRESSURE WAS NOTED. ANGIO SHOWED A RUPTURE IN THE AORTA DISTAL TO THE BOTTOM OF THE VALIANT NAVION. AN ENDURANT II AUI STENT GRAFT WAS THEN IMPLANTED UP TO THE LEVEL OF THE RENAL ARTERIES TO TREAT THE RUPTURE. IT WAS REPORTED THAT AFTER PLACEMENT OF THE AUI ANOTHER ANGIO SHOWED THERE WAS STILL EXTRAVASATION BETWEEN THE RENAL ARTERIES AND THE SMA SO IT WAS DECIDED TO PLACE AN ENDURANT II STENT GRAFT CUFF UP TO THE DISTAL LEVEL OF THE SMA. ANGIO AT THIS POINT DID NOT SHOW ANY EXTRAVASATION IN THE VISCERAL SEGMENT OR THE INFRA-RENAL PORTION OF THE SEAL ZONE INTO THE ANEURYSM IN THE ABDOMINAL AORTA. HOWEVER, IT WAS REPORTED THAT A TYPE IB ENDOLEAK WAS SEEN ARISING FROM THE LEFT ILIAC ARTERY AT THE DISTAL END OF THE AUI. AN ENDURANT II STENT GRAFT LIMB WAS PLACED INTO THE LEFT COMMON ILIAC ARTERY

  Patient problems: Death; Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 9001292 ↗
• DeathAug 28, 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 EMERGENCY ENDOVASCULAR TREATMENT OF A 300 MM DIAMETER THORACIC AORTIC TYPE B DISSECTION AND IMH. IT WAS REPORTED THAT A FEW DAYS AFTER THE IMPLANT PROCEDURE, WHILE THE PATIENT WAS STILL IN HOSPITAL, THE PATIENT WAS BROUGHT TO THE OPERATING ROOM AND THE AORTA WAS OPENED. THE PHYSICIAN NOTED THAT THE PATIENT HAD A TYPE A RETROGRADE DISSECTION. THE DISSECTION WAS REPAIRED, HOWEVER THE PATIENT LATER DIED. AS PER THE PHYSICIAN, THE CAUSE OF THE DEATH WAS THE TYPE A DISSECTION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death; Intimal Dissection

  MAUDE report 8940083 ↗
• MalfunctionJun 18, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55 MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, WHEN THE PHYSICIAN WAS DEPLOYING THE DEVICE, THEY NOTICED THAT THE TIP CAPTURE MECHANISM HAD NOT RELEASED AFTER THE RELEASE HANDLE HAD BEEN FULLY RETRACTED. AS THE PHYSICIAN RETRACTED THE RELEASE HANDLE, THE STENT GRAFT MOVED BACK WITH THE RETRACTING PART OF THE TIP CAPTURE MECHANISM. THE PHYSICIAN THEN PUSHED THE DELIVERY SYSTEM TOWARDS THE PATIENT'S HEAD, WHICH PUT THE STENT GRAFT BACK IN THE CORRECT POSITION. HOWEVER THE TIP CAPTURE MECHANISM HAD STILL NOT RELEASED, SO THE PHYSICIAN MOVED THE DELIVERY HANDLE UP AND DOWN IN AN ATTEMPT TO RELEASE IT, HOWEVER THIS WAS NOT SUCCESSFUL. THE PHYSICIAN THEN ROTATED THE DELIVERY HANDLE, WHICH RELEASED THE TIP CAPTURE MECHANISM. THE DELIVERY SYSTEM WAS THEN REMOVED FROM THE PATIENT SUCCESSFULLY PER IFU AND THE PROCEDURE WAS COMPLETED. THE STENT GRAFT WAS DEPLOYED IN THE DESIRED POSITION, JUST DISTAL TO THE AORTIC ARCH IN THE STRAIGHT DESCENDING SECTION. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707708 ↗