Valiant Navion™ VNMC3737C182TU (UDI 00763000101060)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00763000101060), received between Feb 22, 2019 and Jan 4, 2024 — classified as 7 deaths, 12 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (12 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 200MM DISSECTION. IT WAS REPORTED APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH BACK AND CHEST PAIN. IT WAS NOTED THAT THE PATIENT HAD BROKEN RIBS AND PNEUMONIA. NO ENDOLEAK WAS NOTED IN THE STENT GRAFT. THE PHYSICIAN DECIDED TO EXTEND PROXIMALLY AND DISTALLY AND IMPLANTED TWO VALIANT CAPTIVIA STENT GRAFTS. NO CAUSE WAS PROVIDED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Chest Pain; Pneumonia

  MAUDE report 18445612 ↗
• MalfunctionDec 21, 2023Fracture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Fracture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT . IT WAS REPORTED ON UNKNOWN DATE, FOLLOW UP CT SCAN REVEALED A POSSIBLE STENT RING ENLARGEMENT. CORELAB REVIEWED CT IMAGING 3 YEARS AND 8 MONTHS POST THE INDEX PROCEDURE AND IDENTIFIED A NEW FRACTURE ON (B)(6) AND ALSO STENT RING ENLARGEMENT ON RING 4 ON THE STENT GRAFT (B)(6). NO ENDOLEAK OR STENT RING MIGRATION WERE NOTED. THE MAXIMUM AORTIC DIAMETER WAS 56.9MM. PER THE PHYSICIAN THE CAUSE OF THE STENT RING ENLARGEMENT IS UNKNOWN.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18377569 ↗
• InjuryApr 25, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM ON IT WAS REPORTED THAT A FOLLOW-UP CT TAKEN 2 YEARS AND 9 MONTHS POST INDEX PROCEDURE SHOWED AN UNKNOWN ENDOLEAK. THE VALIANT NAVION STENT GRAFTS WERE RELINED ON THE SAME DATE WITH A VALIANT CAPTIVIA (S/N (B)(6) BUT THE ENDOLEAK REMAINED. PER THE PHYSICIAN, THE CAUSE OF THE ENDOLEAK IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED WILL BE MONITORED

  Patient problems: Insufficient Information

  MAUDE report 16805137 ↗
• DeathFeb 1, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED TAA AND DISSECTION .  IT WAS REPORTED THAT CORELAB HAVE REVIEWED CT IMAGING AND HAVE IDENTIFIED A TYPE IA ENDOLEAK ON THE STENT GRAFT WITH SN (B)(4). NO FRACTURE, STENT RING ENLARGEMENT/MIGRATION WERE NOTED. THE MAXIMUM AORTIC DIAMETER WAS 54.6MM.  THE CAUSE OF THE EVENT CAN NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 16276167 ↗
• MalfunctionJan 3, 2023Material Deformation; Material Deformation

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA .  CORELAB HAVE REVIEWED CT IMAGING FOR THIS PATIENT. OVER 2.5 YEARS LATER , A CT TAKEN IDENTIFIED STENT RING ENLARGEMENT OF + 1.4MM ON THE STENT GRAFT V08141303. NO ENDOLEAK, FRACTURE OR STENT RING MIGRATION WERE NOTED.  AORTIC ENLARGEMENT OF +7.8MM WAS ALSO IDENTIFIED WHEN COMPARED TO IMAGING TAKEN PREVIOUSLY.  FURTHER CT IMAGING REVIEWED THAT WAS TAKEN A FURTHER YEAR LATER , IDENTIFIED THE STENT RING ENLARGEMENT OF +1.9MM (PERSISTENT) ON THE STENT GRAFT V08141303. NO ENDOLEAK, FRACTURE OR STENT RING MIGRATION WERE NOTED. THE AORTIC ENLARGEMENT WAS FOUND TO BE +7.3MM.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm

  MAUDE report 16086851 ↗
• DeathAug 15, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF >60MM TAAA AFTER UNDERGOING A LSA-LCCA BYPASS . THE PROCEDURE WAS DONE BY PLACING THREE SEPARATE VALIANT NAVION STENT GRAFTS INSIDE OF THE DESCENDING AORTA. THE DEVICES WERE PLACED TO COVER ZONES 2 TO 5, WITH ONE GRAFT EXTENDING FROM ZONE 2-4, ANOTHER FROM ZONE 3- 5, AND A THIRD GRAFT FROM ZONE 4 TO 5. AFTER THE STENTS WERE DEPLOYED, ANGIOGRAPHIC EVALUATION WAS REPORTED AS SHOWING NO EVIDENCE OF ENDOLEAK IT WAS REPORTED THAT 9 MONTHS LATER THE PATIENT EXPERIENCED BACK PAIN. THE PATIENT WAS DIAGNOSED WITH ST-ELEVATION MYOCARDIAL INFARCTION AND INTUBATED AND TRANSFERRED TO ANOTHER HOSPITAL. A CT WAS PERFORMED, WHICH SHOWED THAT THE PATIENT SUFFERED FROM AN ASCENDING AORTIC ANEURYSM WITH LEAKING INTO THE PERICARDIAL SAC AND MULTIPLE AREAS OF PROBABLE TYPE IIIB ENDOLEAKS FROM THE VALIANT NAVION STENT GRAFTS IN ZONE 4 AND 5. THE PATIENT EXPIRED ON THE SAME DAY. IT WAS REPORTED PER A MEDICAL EXPERT TO A REASONABLE DEGREE OF MEDICAL PROBABILITY THAT THE PROBABLE TYPE IIIB ENDOLEAKS IN THE PATIENTS VALIANT NAVION STENT GRAFTS WERE A SUBSTANTIAL FACTOR IN CAUSING HIS DEATH.  NO ADDITIONAL CLINIC

  Patient problems: Aneurysm; Bradycardia; Cardiac Arrest; Dyspnea; Fatigue; Low Blood Pressure/ Hypotension; Myocardial Infarction; Pain; Pleural Effusion; Vascular Dissection

  MAUDE report 15223413 ↗
• InjuryJun 13, 2022Fracture; Leak/Splash; Migration or Expulsion of Device; Material Deformation; Fracture; Leak/Splash; Migration or Expulsion of Device; Material Deformation

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A 57MM THORACIC AORTIC ANEURYSM. THE PATIENT HAD PRESENTED WITH PAIN.  ANOTHER VALIANT NAVION (V29931586) WAS THEN IMPLANTED UNDER TWO MONTHS LATER TO ADDRESS A MORE DISTAL DEFECT THAT WAS BEING WATCHED AND DELAYED TO PREVENT SPINAL CORD ISCHEMIA. THE ORDER OF THE IMPLANTED DEVICES WERE REPORTED AS FOLLOWS: 31-31-90 NAVION DEPLOYED FIRST, THEN 37-37-182, FOLLOWED BY A 37-37-182 LATER. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN. A CT PERFORMED SHOWED THE PRESENCE OF A TYPE IIIB ENDOLEAK THE PHYSICIAN REALIGNED THE NAVION STENT GRAFTS WITH TWO VALIANT CAPTIVIA STENT GRAFTS. DURING THE INTERVENTION, UNDER FLUOROSCOPY, STENT RING ENLARGEMENT OF THE VALIANT NAVION DEVICE WAS SEEN ALONG WITH STENT GRAFT FATIGUE WITH FAILURE/ BREAKAGE, AND A TYPE III B ENDOLEAK VIA FENESTRATION. THE PATIENT WAS DISCHARGED TWO DAYS LATER. PER THE PHYSICIAN, IT WAS NOT POSSIBLE TO IDENTIFY WHICH VALIANT NAVION FAILED CAUSING THE TYPE IIIB ENDOLEAK, STENT RING ENLARGEMENT OR FRACTURE. NO CAUSE FOR THE TYPE III ENDOLEAK, FRACTURE OR STENT RING ENLARGEMENT WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WA

  Patient problems: Pain

  MAUDE report 14673276 ↗
• InjuryJun 13, 2022Fracture; Leak/Splash; Material Deformation; Fracture; Leak/Splash; Material Deformation

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A 57MM THORACIC AORTIC ANEURYSM . THE PATIENT HAD PRESENTED WITH PAIN.  ANOTHER VALIANT NAVION (V29931586) WAS THEN IMPLANTED OVER TWO MONTHS LATER TO ADDRESS A MORE DISTAL DEFECT THAT WAS BEING WATCHED AND DELAYED TO PREVENT SPINAL CORD ISCHEMIA. THE ORDER OF THE IMPLANTED DEVICES WERE REPORTED AS FOLLOWS: 31-31-90 NAVION DEPLOYED FIRST, THEN 37-37-182, FOLLOWED BY A 37-37-182 LATER. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN. A CT PERFORMED SHOWED THE PRESENCE OF A TYPE IIIB ENDOLEAK THE PHYSICIAN REALIGNED THE NAVION STENT GRAFTS WITH TWO VALIANT CAPTIVIA STENT GRAFTS. DURING THE INTERVENTION, UNDER FLUOROSCOPY, STENT RING ENLARGEMENT OF THE VALIANT NAVION DEVICE WAS SEEN ALONG WITH STENT GRAFT FATIGUE WITH FAILURE/ BREAKAGE, AND A TYPE III B ENDOLEAK VIA FENESTRATION. THE PATIENT WAS DISCHARGED TWO DAYS LATER. PER THE PHYSICIAN, IT WAS NOT POSSIBLE TO IDENTIFY WHICH VALIANT NAVION FAILED CAUSING THE TYPE IIIB ENDOLEAK, STENT RING ENLARGEMENT OR FRACTURE. NO CAUSE FOR THE TYPE III ENDOLEAK, FRACTURE OR STENT RING ENLARGEMENT WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WA

  Patient problems: Pain

  MAUDE report 14673273 ↗
• InjuryMay 30, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION AND THORACIC AORTIC ANEURYSM.  IT WAS REPORTED THE PATIENT RETURNED FOR A CT ONE WEEK POST THE INDEX PROCEDURE WHICH SHOWED THE LUMEN HAD INCREASED, THERE WAS NO SIGN OF  AN ENDOLEAK OR INCREASE OF AORTA. THE PHYSICIAN DECIDED TO CARRY OUT AN INTERVENTION TO EXTEND THE STENT BY IMPLANTING A VALIANT NAVION STENT GRAFT 3 MONTHS POST THE INDEX PROCEDURE. APPROXIMATELY 17 MONTHS POST THE INDEX PROCEDURE THE PATIENT RETURNED FOR A CT AND PERSISTENT FALSE LUMEN FILLING AND AORTA ENLARGEMENT WAS OBSERVED. THE PHYSICIAN INTERVENED WITH EXTENSION OF THE STENT GRAFTS AND THE CASE WAS RESOLVED. RECENT CT TAKEN APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE IS NORMAL.   AS PER THE PHYSICIAN THE CAUSE OF THE FALSE LUMEN PERFUSION AND AORTA ENLARGEMENT WAS DUE TO THE USE UNDERSIZED STENT GRAFTS. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENTIS FINE.

  Patient problems: Aneurysm; Insufficient Information

  MAUDE report 14539988 ↗
• MalfunctionMay 10, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED AS PART OF THE RE-INTERVENTION FOR A PRIOR AORTIC REPAIR.  IT WAS REPORTED ON THE DATE OF CT, AN UNKNOWN ENDOLEAK WAS OBSERVED.  NO CAUSE OF THE ENDOLEAK WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14345651 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM ON (B)(6) 2021. IT WAS REPORTED THAT, DURING A FOLLOW UP CT, A 2 CM SACCULAR ANEURYSM WITH SAC EXPANSION WAS NOTED. AN INTERVENTION OCCURRED WHERE THE STENT GRAFT WAS RELINED WITH A NON MDT STENT GRAFT. IT WAS ALSO CONFIRMED THAT THERE WAS NO ENDOLEAKS OR DEVICE MALFUNCTION IDENTIFIED DURING THE INTERVENTION. PER PHYSICIAN THE CAUSE OF THE EXPANSION WAS POTENTIALLY DUE TO DEVICE COMPROMISE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm; Chest Pain

  MAUDE report 13928290 ↗
• InjuryMar 14, 2022Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 6 YEARS POST THE INDEX PROCEDURE, TWO VALIANT NAVION DEVICES WERE IMPLANTED DUE TO ADVANCED DISEASE PROGRESSION. IT WAS FURTHER REPORTED THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE WITH BACK AND SCAPULAR PAIN THAT HAD BEEN INCREASING OVER THE PREVIOUS MONTH. A CT REVEALED A LEFT HEMOTHORAX AND A 90MM THORACIC AORTIC ANEURYSM WITH CLEAR CONTRAST COMMUNICATION INTO THE ANEURYSM SAC. THE PATIENT WAS TRANSFERRED FOR TREATMENT OF THE ENLARGED ANEURYSM. DURING THE INTERVENTION THE PHYSICIAN NOTED THE ANEURYSM ENLARGEMENT WAS DUE TO SEPARATION BETWEEN SECONDARILY PLACED GRAFTS AND THE GRAFT WHICH WAS IMPLANTED DURING THE INDEX PROCEDURE (VNM3737C182TU DEVICE AND VAMF3232C100TU). THE PHYSICIAN IMPLANTED A VALIANT CAPTIVA DEVICE ACROSS THE DISUNION AND PLACED ANOTHER STENT GRAFT PROXIMALLY. THE ORDER OF DEVICES IMPLANTED ARE VNMC3737C182TU, VNMC3737C182TU AND VAMF3232C100TU. THE APPEARANCE OF THE STENT RING ENLARGEMENT WAS OBSERVED IN THE DISTAL VNM3737182 NAVION THAT HAD BEEN JOINED FROM THE EXISTING VALIANT CAPTIVA.

  Patient problems: Hemothorax; Pain

  MAUDE report 13755862 ↗
• MalfunctionMar 11, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC DISSECTION . IT WAS REPORTED THE PATIENT HAD A FOLLOW-UP CT WHERE AN UNKNOWN ENDOLEAK WAS OBSERVED BY CORELAB IMAGING REVIEW. NO STENT FRACTURE OR STENT RING ENLARGEMENT WERE OBSERVED. NO CAUSE AS PER THE PHYSICIAN WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13731261 ↗
• MalfunctionMar 3, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC ANEURYSM .  IT WAS REPORTED THE PATIENT RETURNED FOR A FOLLOW-UP CT WHERE A TYPE IB AND POTENTIAL TYPE III ENDOLEAK WERE OBSERVED.  AS PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAKS WAS AS A RESULT OF THE PATIENTS OWN ANATOMY AS A RESULT OF AORTIC DILATION.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13658146 ↗
• DeathDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN THORACIC AORTIC ANEURYSM AND DIS SECTION.  IT WAS REPORTED THAT THE PATIENT EXPIRED 22 DAYS LATER. THE CAUSE OF DEATH IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE HAS BEEN PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 12932940 ↗
• DeathNov 15, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A RUPTURED THORACIC AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE THE PATIENT SUFFERED FROM AN AORTIC DISSECTION AND EXPIRED. AS PER THE PHYSICIAN THE CAUSE OF THE DISSECTION WAS DUE TO GRAFT FAILURE. THE CAUSE OF DEATH WAS DUE TO AORTIC ANEURYSM WITH AN AORTIC DISSECTION. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Ruptured Aneurysm; Vascular Dissection

  MAUDE report 12810963 ↗
• DeathNov 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE . IT WAS REPORTED THAT THE PATIENT EXPIRED 10 DAYS LATER. AS PER THE PHYSICIAN THE CAUSE OF DEATH WAS DUE TO RESPIRATORY FAILURE AND SEPTIC SHOCK AND DESCENDING AORTIC DISSECTION. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Respiratory Failure; Septic Shock; Tachycardia; Vascular Dissection

  MAUDE report 12750520 ↗
• InjuryOct 7, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN AN UNKNOWN  ENDOVASCULAR TREATMENT..  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REINTERVENTION FOR AN ALLEGED TYPE IIIB ENDOLEAK. IT WAS BELIEVED THE INTERVENTION WAS SUCCESSFUL.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12590619 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AORTIC DISSECTION. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, A EXTENSION OF THE DISSECTION OCCURRED. THERE WAS NO PATIENT INSTABILITY AND THEREFORE NO FURTHER TREATMENT WAS PERFORMED. THE SITE ASSESSED THIS EVENT AS NOT RELATED TO THE DEVICE OR PROCEDURE BUT PROBABLY RELATED TO THE DISSECTION. THE SPONSOR ASSESSED THIS EVENT AS RELATED TO THE DEVICE, PROCEDURE AND DISSECTION. THIS EVENT IS REPORTED AS UNRESOLVED. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Vascular Dissection

  MAUDE report 10866803 ↗
• MalfunctionSep 18, 2020Inadequacy of Device Shape and/or Size; Material Deformation; Inadequacy of Device Shape and/or Size; Material Deformation

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT THE PATIENT PRESENTED TO ANOTHER HOSPITAL OTHER THAN THE HOSPITAL THAT THE DEVICE WAS PREVIOUSLY IMPLANTED. A CT WAS PERFORMED APPROXIMATELY 3 MONTHS POST INDEX PROCEDURE, WHERE IT WAS NOTED, THAT THE IMPLANTED STENT GRAFT WAS OVER-SIZED AND HAS COLLAPSED IN TWO PLACES. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS DUE TO THE DEVICE BEING OVER-SIZED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10552965 ↗
• DeathMar 18, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE ANEURYSM HAD RUPTURED DUE TO A TYPE IIIA ENDOLEAK. THERE WAS THOUGHT TO BE A SEPARATION BETWEEN THE (MAIN BODY AND CUFF) FROM A PREVIOUS ENDOVASCULAR REPAIR WITH A NON-MDT DEVICE. THE PHYSICIAN FELT THAT THE PATIENT WOULD NOT SURVIVE AND OPEN REPAIR SO IT WAS DECIDED TO USE THE VALIANT NAVION TO BRIDGE THE TWO NON-MDT GRAFT COMPONENTS. IT WAS REPORTED THAT THE PHYSICIAN PLACED THE GRAFT TOO HIGH AND WAS NOT ABLE TO GET THE DISTAL SEAL INTO THE MAIN BODY OF THE NON-MDT GRAFT. THE PHYSICIAN TRIED BALLOONING AND PULLING DOWN THE NAVION BUT THE INTERNAL STENTS OF THE NON-MDT GRAFTS PREVENTED DOWNWARD MOVEMENT. IT WAS THEN DECIDED TO PROCEED WITH A OPEN REPAIR. THE PHYSICIAN WAS UNABLE TO GET PROXIMAL CONTROL OF THE GRAFT BUT THE PATIENT SUBSEQUENTLY WENT INTO CARDIAC ARREST AND EXPIRED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS BECAUSE THE PREVIOUSLY IMPLANTED NON MDT STENT GRAFT MADE IT DIFFICULT TO SEE THE NAVION DEVICE AND SUBSEQUENTLY IT WAS IMPLANTED TOO PROXIMALLY. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIE

  Patient problems: Cardiac Arrest; Death

  MAUDE report 9848615 ↗
• DeathMar 10, 2020Malposition of Device; Malposition of Device

  A VALIANT NAVON STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL THORACIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE NAVION STENT GRAFT VNMC3737C182 WAS INADVERTENTLY DEPLOYED ACROSS THE PARAVISCERAL SEGMENT. CONVERSION TO OPEN ABDOMINAL REPAIR WAS CARRIED OUT AND THE DEVICE WAS REMOVED SURGICALLY, AND AN ADDITIONAL PIECE WAS PLACED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED OCCLUSION OF THE RENAL ARTERIES, CELIAC AND SMA AFTER THE CASE AND EXPIRED THE NEXT DAY DUE TO THE COMPLICATIONS. IT WAS CONFIRMED THAT THE OCCLUSION WAS DUE TO THE GRAFT BEING PLACED OVER THE PARAVISCERAL SEGMENT AND THAT THE GRAFT WAS RELATED TO THE OCCLUSION. IT WAS REPORTED THAT THE GRAFT DID WHAT IT IS SUPPOSED TO DO (EXCLUDE FLOW OUTSIDE THE GRAFT) BUT THE PLACEMENT AND POSITION OF THE GRAFT WAS ACROSS THOSE VESSELS. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Death; Occlusion

  MAUDE report 9810655 ↗
• MalfunctionJan 7, 2020Activation, 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 286MM THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE BLUE SCREW GEAR WAS ROTATED TO DEPLOY THE DEVICE VNMC3737C182TU. IT WAS REPORTED THAT THE BLUE SLIDER WOULD ROTATE BUT DID NOT MOVE OR DEPLOY THE DEVICE. IT WAS ALSO REPORTED THAT THE SLIDER MADE CLICKING NOISE WHEN ROTATED. THE TRIGGER WAS NOTED TO HAVE BEEN FORWARD DURING THE ROTATIONS. THE PHYSICIAN WAS ABLE TO USE THE QUICK RELEASE TRIGGER TO DEPLOY THE DEVICE. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9557049 ↗
• InjuryJul 4, 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 PENETRATING ATHEROSCLEROTIC ULCER (PAU) WITH INTRA-MURAL HAEMATOMA (IMH) IN THE THORACIC AORTA. THE DIAMETER OF THE PROXIMAL THORACIC AORTA WAS 37MM, THE DEGREE OF ANGULATION OF THE AORTIC ARCH WAS 100 AND SEVERE TORTUOSITY WAS NOTED IN THE THORACIC AORTA. THE PATIENT HAD IMH ALL THE WAY TO THE LEFT SUBCLAVIAN ARTERY (LSA) BUT IT WAS DECIDED TO LAND 30-40MM DISTALLY OF THE LSA TO AVOID LANDING THE STENT GRAFT IN TORTUROUS ANATOMY. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH A RETROGRADE TYPE B DISSECTION PROXIMAL TO THE NAVION STENT GRAFT APPROXIMATELY THREE MONTHS LATER. AN INTERVENTION PROCEDURE WAS CARRIED OUT THE FOLLOWING DAY. A NON-MDT CUFF WAS IMPLANTED AND A SUBCLAVIAN BYPASS CARRIED OUT TO RESOLVE THE EVENT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Intimal Dissection

  MAUDE report 8762377 ↗
• InjuryApr 19, 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 65 MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT AFTER THE INDEX PROCEDURE, THE PHYSICIAN WAS NOTIFIED THAT THE PATIENT HAD SUFFERED A POSSIBLE CRANIAL BLEED. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.

  Patient problems: Stroke/CVA

  MAUDE report 8530690 ↗