Valiant Navion™ VNMF3434C174TU (UDI 00763000100643)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000100643), received between Feb 14, 2019 and Jan 9, 2024 — classified as 4 deaths, 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2024Fracture; Leak/Splash; Fracture; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A RUPTURED TAA. IT WAS REPORTED APPROXIMATLEY 3 YEARS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A THORACIC RUPTURE WHILE ADMITTED TO THE HOSPITAL FOR OTHER ISSUES.  A CT SHOWED A FRACTURE WITHIN THE EXISTING VALIANT NAVION STENT GRAFT. INTERVENTION WAS PERFORMED AND THE PHYSICIAN RELINED THE VALIANT NAVION USING TWO VALIANT CAPTIVIA STENT GRAFTS ON THE SAME DATE. THE RUPTURE WAS EXCLUDED SUCCESSFULLY. PER THE PHYSICIAN THE CAUSE OF THE FRACTURE AND SUBSEQUENT RUPTURE COULD NOT BE DETERMINED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Rupture

  MAUDE report 18473568 ↗
• DeathSep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO VALIANT NAVION STENT GRAFTS AND AN ENDURANT II STENT GRAFT SYSTEM WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A TAA. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE THE PATIENT WAS TRANSFERRED FROM ANOTHER HOSPITAL WITH CHEST PAIN. A 150MM TAA AND A SUSPECTED TYPE III ENDOLEAK FROM PRE-EXISTING GRAFT COMPONENTS WAS SEEN ON A CT. INTERVENTION WAS PERFORMED, THE VALIANT NAVION STENT GRAFTS WERE RE-LINED WITH 2 VALIANT CAPTIVIA STENT GRAFTS. VAMF4242C150TU WAS PLACED INSIDE PRE-EXISTING ENDOGRAFT WITHOUT SUBCLAVIAN COVERAGE. VAMC4242C150TU WAS PLACED ABOVE THE CHIMNEY STENTS FOR VISCERAL LEVEL. BOVINE PERICARDIAL PATCH WAS USED FOR ANGIOPLASTY OF RIGHT FEMORAL ARTERY. APPROXIMATELY 3 MONTHS POST THE INTERVENTION, 2 ADDITIONAL VALIANT CAPTIVIA STENT GRAFTS AND 2 ENDURANT II LIMBS WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT WAS IN SURGICAL ICU WITH CONCERN FOR ABDOMINAL COMPARTMENT SYNDROME AND THEY WERE TAKEN TO THE OR FOR AN EVALUATION OF THE BLEED. THE PATIENT EXPIRED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE. THE CAUSE WAS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Abdominal Distention; Chest Pain; Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions; Swelling/ Edema

  MAUDE report 17787354 ↗
• DeathFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A DISSECTION. IT WAS CONFIRMED THE STENT GRAFT (B)(4) WAS IMPLANTED PROXIMALLY. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PATIENT WAS FOUND TO HAVE A INTIMAL DEFECT AT THE PROXIMAL LANDING SITE CAUSING A TYPE A DISSECTION AND IA ENDOLEAK.  A CT WAS PERFORMED APPROXIMATELY 8 MONTHS POST THE INDEX PROCEDURE, WHICH SHOWED THE TYPE IA ENDOLEAK. ANOTHER CT  ALSO SHOWED THE TYPE IA ENDOLEAK AND AORTIC ENLARGEMENT AT THE PROXIMAL TEVAR SITE.  INTERVENTION WAS PERFORMED, A NON MDT STENT GRAFT WAS PLACED IN THE AORTIC ARCH. AT ANOTHER INTERVENTION DATE A LSCA BYPASS WAS PERFORMED AND A NON MDT AORTIC ROOT GRAFT WAS PLACED DURING A HEMI ARCH REPLACEMENT.  CORELAB REVIEWED CT IMAGING DATED ON (B)(6) 2020; THE TYPE IA ENDOLEAK WAS NOTED ON THE STENT GRAFT (B)(4). NE FOR FRACTURES ON THIS STENT GRAFT DUE TO DEVICE OVERLAPS. NO FRACTURES WERE NOTED OTHERWISE, NO STENT RING ENLARGEMENT OR STENT RING MIGRATION. THE MAXIMUM AORTIC DIAMETER WAS 70.8MM. IT WAS REPORTED THE PATIENT DIED ON AN UNKNOWN DATE. THE CAUSE OF DEATH IS UNKNOWN.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Cardiac Arrest; Insufficient Information; Liver Failure; Pericardial Effusion; Shock

  MAUDE report 16361017 ↗
• MalfunctionJul 27, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM.  IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE FOLLOW UP CT IDENTIFIED ANEURYSM ENLARGEMENT. PER THE PHYSICIAN THE CAUSE OF THE ENLARGEMENT IS A QUESTIONABLE TYPE II ENDOLEAK.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15111278 ↗
• DeathJun 28, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 52MM THORACIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 15 MONTHS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY IN CRITICAL CONDITION COMPLAINING OF CHEST PAIN, MID BACK PAIN, HIGH BP AND NUMBNESS AND TINGLING IN THE LOWER EXTREMITIES. A CT ON (B)(6) 2021 SHOWED GROWTH IN THE AORTIC DIAMETER (60MM)) AND INTERVAL DEVELOPMENT OF AN ACUTE TYPE B DISSECTION OF THE THORACIC ANEURYSM FROM THE DISTAL STENT EDGE. THE NEW AORTIC DISSECTION INVOLVED THE DISTAL DESCENDING THORACIC AORTA, ORIGINATING DISTAL TO THE LEVEL OF THE PRE-EXISTING ENDOGRAFT WITH AN INCREASE IN SIZE OF DISTAL THORACIC AND PROXIMAL ABDOMINAL AORTIC ANEURYSM AT LEVEL OF DISSECTION FROM 54MM TO 56MM. A TYPE IB ENDOLEAK WHICH APPEARED LOCALIZED TO THE DISTAL END OF THE GRAFT WITHIN THE DESCENDING THORACIC AORTA WAS ALSO OBSERVED. CRITICAL TREATMENT WAS PROVIDED AND THE PATIENT DISCHARGED, HOWEVER THE PATIENT EXPIRED ON (B)(6) 2021.  PER THE PHYSICIAN THE CAUSE OF THE ENLARGEMENT, DISSECTION AND ENDOLEAK ARE UNDETERMINED. THE CAUSE OF DEATH WAS DUE TO THE DISSECTION OF THE THORACIC AORTIC ANEURYSM. NO ADDITIONAL CLINICAL SEQUELAE WERE R

  Patient problems: Chest Pain; High Blood Pressure/ Hypertension; Numbness; Pain; Vascular Dissection

  MAUDE report 14841445 ↗
• DeathOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED¿ FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. AN ENDURANT II AUI STENT GRAFT WAS ALSO IMPLANTED ON THE SAME DATE. IT WAS REPORTED THAT THE PATIENT EXPIRED ON THE SAME DAY OF THE INDEX PROCEDURE. THE CAUSE OF DEATH WAS NOTED AS CARDIOPULMONARY. THE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 12631619 ↗
• InjuryOct 22, 2020Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE, FOLLOW UP CT IDENTIFIED A TYPE IA ENDOLEAK. THE PHYSICIAN PERFORMED A CAROTID TO SUBCLAVIAN BYPASS AND EXTENDED THE GRAFT TO THE ORIGIN OF THE LEFT CAROTID. AN ADDITIONAL VALIANT STENT GRAFT (VNMF3434C97TU V08246247) WAS IMPLANTED AND THE ENDOLEAK WAS CONFIRMED AS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK WAS DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 10717950 ↗
• MalfunctionJan 27, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR FOLLOW-UP ON AN UNKNOWN DATE IT WAS NOTED THAT THE ANEURYSM HAD DECREASED IN SIZE BUT THE STENT GRAFT WAS NOW KINKING. IT WAS REPORTED THAT THERE HAS BEEN NO CLINICAL DECLINE FOR THE PATIENT AND THEY REMAINED ASYMPTOMATIC. IT WAS REPORTED THAT IN THIS CASE THE DEVICE WAS USED IN A STAGED REPAIR AND LANDED INTO THE ELEPHANT TRUNK. IT WAS REPORTED THAT IS THOUGHT THAT ANEURYSM REMODELING HAD OCCURRED SINCE THE ANEURYSM HAS NOW DECREASED IN SIZE, AND BECAUSE THE ELEPHANT TRUNK IS NOW NOTED TO BE FLOPPY THE STENT GRAFT IS NOW KINKING SLIGHTLY. 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: No Consequences Or Impact To Patient

  MAUDE report 9631321 ↗
• InjuryApr 23, 2019Malposition of Device; Malposition of Device

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 60MM THORACIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE WHEN THE PHYSICIAN WAS BALLOONING AT THE JUNCTION/OVERLAP BETWEEN THE 1ST AND 2ND STENT GRAFTS IT WAS NOTED THAT THE PROXIMAL EDGE OF THE GRAFT WAS NOTED TO BE 1CM DISTAL FROM THE ORIGINAL POSITION AFTER INITIAL SUCCESSFUL DEPLOYMENT. AT THIS TIME THE MEAN ARTERIAL PRESSURE WAS NOTED AS 82 AND THE PHYSICIAN REQUESTED THAT IT BE LOWERED TO 60. THE PHYSICIAN THEN IMPLANTED A 3RD NAVION STENT GRAFT (37X37X174) BACK UP TO THE INTENDED POSITION AT THE LSA AND THE EVENT RESOLVED. IT WAS REPORTED THAT THERE WAS NOTHING UNUSUAL REGARDING TORTUOSITY AND PLAQUE WITHIN THE ANATOMY. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS RELATED TO THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8539301 ↗
• MalfunctionFeb 14, 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 200MM DISSECTION. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, VNMF3434C229TU WAS ADVANCED OVER A LUNDERQUIST WIRE WITH MODERATE FORCE TO ADVANCE THE DEVICE THROUGH TORTUOUS ANATOMY. IT WAS REPORTED THAT ONCE THE GRAFT WAS IN POSITION DEPLOYMENT WAS ATTEMPTED BUT THE SCREW GEAR WOULD NOT TURN. IT WAS REPORTED THAT THE TRIGGER WAS THEN ATTEMPTED TO BE PULLED TO TRY DEPLOYING AGAIN. THE DEVICE WAS THEN REMOVED AND A KINK WAS NOTED ON THE GRAFT COVER. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED BUT IT WAS NOTED THAT THERE WAS EXTREMELY TORTUROUS ANATOMY. IT WAS ALSO REPORTED THAT WHEN ATTEMPTING TO IMPLANT VNMF3434C174TU THE STENT GRAFT DEPLOYED SUCCESSFULLY BUT WHEN THE DELIVERY SYSTEM AND WIRE WAS RELAXED TO RELEASE THE TIP CAPTURE THE TIP CAPTURE ONLY RELEASED HALFWAY. IT WAS ATTEMPTED TO PUSH SLIGHTLY FORWARD AND TRY TO RELEASE THE TIP CAPTURE BUT AGAIN IT DIDN¿T FULLY RELEASE AGAIN. THE BACK BLUE HANDLE WAS THEN SEPARATED AND THE TIP CAPTURE WAS MANUALLY RELEASED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUEL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8338930 ↗