Valiant Navion™ VNMC3434C182TU (UDI 00763000101022)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00763000101022), received between Dec 4, 2018 and Jul 28, 2025 — classified as 1 death, 16 injuries, 6 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A DISSECTION. IT WAS REPORTED THAT CORELAB REVIEWED CT IMAGING DATED AND IDENTIFIED NEW STENT RING ENLARGEMENT OF +2.6MM ON RING 4, +1.5MM ON RING 2 AND +1.2MM ON RING 3 OF (B)(6). THE MAXIMUM AORTIC DIAMETER IS NOTED AS 44.1MM. NO ENDOLEAKS, FRACTURE OR STENT RING MIGRATION WAS OBSERVED. NO CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628867 ↗
• MalfunctionJul 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  VALIANT NAVION STENT GRAFTS (VNMC3434C182TU <(>&<)> VNMC3131C182TU) WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. IT WAS REPORTED, CORE LAB REVIEW OF CT IMAGING TAKEN APPROX. 3 YEARS AND 6 MONTHS POST INDEX PROCEDURE REVEALED A STENT RING ENLARGEMENT OF (+1.4MM), RING 5 (NEW) ON THE VALIANT NAVION STENT GRAFT (VNMC3434C182TU /(B)(6)). PER THE PHYSICIAN THE CAUSE OF THE STENT RING ENLARGEMENT IS UNDETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19804179 ↗
• InjuryJul 1, 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 THORACIC AORTIC DISSECTION AS PART OF THE DISSECT- N STUDY. IT WAS REPORTED APPROXIMATELY 12 MONTHS POST THE INDEX PROCEDURE THE PATIENT HAD SURGERY ON THE VALIANT NAVION GRAFT. POST THE PROCEDURE THE PATIENT HAD DYSPHAGIA AND DYSPHONIA WITH DIAGNOSED LEFT VOCAL CORD IMMOBILITY LIKELY FROM DAMAGE TO THE RECURRENT LARYNGEAL NERVE DURING SURGERY. THE PATIENT HAD A MAGNIFIED LARYNGOSCOPY WITH VOCAL CORD INJECTION AUGMENTATION PROCEDURE WITH NO COMPLICATIONS. THE CONDITION IS CONTINUING. THE SITE ASSESSED THE VOCAL CORD IMMOBILITY AS NOT RELATED TO THE DEVICE, NOT RELATED TO THE PROCEDURE AND NOT RELATED TO THE DISSECTION. THE MEDICAL MONITOR ASSESSED THE VOCAL CORD IMMOBILITY AS DEVICE RELATED, NOT RELATED TO THE PROCEDURE AND NOT RELATED TO THE DISSECTION. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Dysphagia/ Odynophagia; Insufficient Information

  MAUDE report 19641834 ↗
• InjuryOct 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 GRAFT AND DEB

  Patient problems: Insufficient Information

  MAUDE report 17928883 ↗
• InjuryJan 25, 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 IN THE ENDOVASCULAR TREATMENT OF A TAA   AROUND 2 YEARS LATER, THE PATIENT UNDERWENT RE-INTERVENTION. 2 NON MDT STENT GRAFTS WERE IMPLANTED OVERLAPPING WITH THE NAVIONS STENT GRAFTS. ADDITIONAL NON MDT STENTS WERE PLACED IN THE BILATERAL COMMON LILACS, EXTENSION OF THE RIGHT EXTERNAL ILIAC WAS PERFORMED USING A NON MDT STENT GRAFT, A  MODIFIED CELIAC ARTERY STENT WAS ALSO PLACED. THE PATIENT UNDERWENT AN CHEVAR PROCEDURE, WHERE A NON MDT STENT GRAFT WAS IMPLANTED ALONG WITH NON MDT STENTS INTO THE RENAL ARTERY AND SMA ARTERY. NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 16239984 ↗
• InjuryJan 16, 2023Adverse 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 UNKNOWN SIZED TAA .  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY UNDER 3 YEARS LATER FOR IV ANTIBIOTICS FOR A STENT GRAFT INFECTION AND AGAIN 4 DAYS LATER . A POSSIBLE ABSCESS ALONG THE UNDERSURFACE OF THE ARCH AT THE ORIGIN OF THE STENT GRAFT WAS ALSO NOTED.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 16173425 ↗
• InjuryDec 14, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION ON THE (B)(6) 2020. THE 34 X 223 MM VALIANT NAVION ENDOGRAFT WAS DEPLOYED AT THE DISTAL ARCH AND THE 34 X 182 MM GRAFT WAS DEPLOYED WITH ADEQUATE OVERLAP UP TO THE CELIAC AXIS. IT WAS REPORTED 10 DAYS POST THE INDEX PROCEDURE AN ADDITIONAL VALIANT NAVION GRAFT (V29565391) WAS IMPLANTED DUE TO A TYPE IA ENDOLEAK. IT WAS NOTED DURING ONE OF THE PROCEDURES ''LARGE TRILOBED BALLOON WAS UTILIZED AND THE ENDOGRAFT WAS BALLOONED AT THE OVERLAPPING SEGMENT AND THE PROXIMAL SEGMENT UNDER RAPID PACING. ANGIOGRAPHY REVEALED ENDOLEAK WITH ADEQUATE FLOW IN THE LEFT CAROTID AND LEFT SUBCLAVIAN ARTERY. IT WAS UNCLEAR IF THIS WAS TYPE I OR TYPE II AND BECAUSE AND TO BETTER DELINEATE THIS AND POTENTIALLY RE-INTERVENE A DECISION WAS MADE TO STOP AT THIS POINT." IT WAS REPORTED APPROXIMATELY 2 MONTHS POST THE INDEX PROCEDURE FOLLOW UP CT OBSERVED A TYPE I ENDOLEAK.  THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 15976267 ↗
• MalfunctionOct 21, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN AN UNKNOWN ENDOVASCULAR TREATMENT .  IT WAS REPORTED A CT WAS TAKEN 16 MONTHS LATER. CORELAB REVIEWED THIS IMAGING AND HAVE SEEN AN UNKNOWN TYPE ENDOLEAK.  NO FRACTURE OR STENT RING ENLARGEMENT/MIGRATION WERE IDENTIFIED.  THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15651891 ↗
• InjuryOct 6, 2022Fracture; Leak/Splash; Migration or Expulsion of Device; Detachment of Device or Device Component; Fracture; Leak/Splash; Migration or Expulsion of Device; Detachment of Device or Device Component

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE EMERGENT ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM ON (B)(6) 2020. IT WAS REPORTED THAT APPROXIMATELY 2 YEARS AND 7 MONTHS POST INDEX PROCEDURE, A FOLLOW UP CT WAS COMPLETED. THE PHYSICIAN IS CONCERNED WITH THE GRAFT INTEGRITY. IN THE THORACIC SEGMENT THE PHYSICIAN IS CONCERNED THAT THE TAA IS GROWING AT THIS TIME OR THAT A PRIOR EVAR HAS BEEN COMPLETED WITH A NON MDT GRAFT IMPLANTED. (B)(6) REVIEWED THESE IMAGES AND CONFIRMED THERE IS STENT RING DISPLACEMENT ( MIGRATION) OF + 3.5MM BETWEEN THE TWO MOST DISTAL STENT RINGS. AORTIC ENLARGEMENT OF +9.7 WAS ALSO NOTED. NO ENDOLEAK OR FRACTURE OR STENT RING ENLARGEMENT WAS NOTED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm; Thrombosis/Thrombus

  MAUDE report 15550337 ↗
• InjuryOct 3, 2022Adverse 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 TYPE B AORTIC DISSECTION. IT WAS REPORTED THAT BETWEEN THE FOLLOWING 2 YEARS, THE PATIENT HAD A TYPE II ENDOLEAK.  ON THE SECOND YEAR POST INDEX PROCEDURE, A TYPE A DISSECTION WAS DIAGNOSED WHICH REQUIRED AN AORTIC VALVE REPLACEMENT.  CT RESULTS FROM APPROXIMATELY 2 YEARS AND 9 MONTHS POST INDEX PROCEDURE SHOWED POSTSURGICAL CHANGES OF AORTIC VALVE REPLACEMENT AND TYPE A DISSECTION REPAIR WITH TUBE GRAFT. NO COMPLICATING INTRATHORACIC FEATURES. THERE WAS NOTED TO BE UNCHANGED APPEARANCE OF THE KNOWN CHRONIC TYPE B DISSECTION EXTENDING INTO THE RIGHT COMMON ILIAC ARTERY STATUS POST TEVAR, ALTHOUGH EVALUATION IS LIMITED BY THE ABSENCE OF INTRAVENOUS CONTRAST. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Vascular Dissection

  MAUDE report 15527760 ↗
• MalfunctionAug 25, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN A PATIENT IN THE ENDOVASCULAR TREATMENT OF A ULCER.  IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE FOLLOW UP CT IDENTIFIED A TYPE IA ENDOLEAK AND AORTIC ENLARGEMENT.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15291571 ↗
• InjuryJun 20, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A DISSECTION AS PART OF A DISSECT-N STUDY ON (B)(6) 2020. IT WAS REPORTED THAT A TYPE IB ENDOLEAK WAS OBSERVED APPROXIMATELY 13 MONTHS POST THE INDEX PROCEDURE. THE PATIENT UNDERWENT AN INTERVENTION PROCEDURE TO REMOVE THE TEVAR. AN OPEN REPAIR OF THE ASCENDING AORTIC ANEURYSM WAS COMPLETED AND THE PATIENT WAS DISCHARGED TO REHAB ONE WEEK POST INTERVENTION AND HOME ONE WEEK LATER. THE TYPE IB ENDOLEAK WAS NOTED TO BE RESOLVED WITH SEQUELAE THE SITE ASSESSED THE TYPE IB ENDOLEAK AS POSSIBLE RELATED TO THE DEVICE, UNLIKELY RELATED TO THE PROCEDURE AND HAVING A CAUSAL (DEFINITE) RELATIONSHIP TO THE DISSECTION. THE MEDICAL MONITOR ASSESSED THE TYPE IB ENDOLEAK AS DEVICE RELATED, NOT PROCEDURE RELATED AND RELATED TO THE DISSECTION. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 14742211 ↗
• InjuryMar 1, 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 SYSTEM WAS IMPLANTED IN AN UNKNOWN SIZE THORACIC AORTIC DISSECTION ON THE (B)(6) 2020. IT WAS REPORTED THAT A CT WAS PERFORMED DURING A 1 YEAR FOLLOW-UP, IDENTIFIED A TYPE IIB ENDOLEAK. THE EVENT IS CONTINUING. THE INVESTIGATOR ASSESSED THE TYPE IIB ENDOLEAK AS NOT RELATED TO INDEX DEVICE OR PROCEDURE, BUT PROBABLY RELATED TO THE DISSECTION. SPONSOR ASSESSED THE TYPE IIB ENDOLEAK AS NOT RELATED TO INDEX DEVICE, BUT RELATED TO INDEX PROCEDURE AND THE DISSECTION. CEC ADJUDICATED THE TYPE IIB ENDOLEAK AS RELATED TO INDEX DEVICE AND NOT RELATED TO INDEX PROCEDURE. ON (B)(6) 2022: IT WAS REPORTED THAT CORELAB REVIEW OF CT IMAGING FROM THE (B)(6) 2021 IDENTIFIED A STENT-INDUCED NEW ENTRY TEAR. THE MAXIMUM AORTIC DIAMETER WAS NOTED TO MEASURE 56MM. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Vascular Dissection

  MAUDE report 13630869 ↗
• InjuryJan 4, 2022Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC ANEURYSM OF AN UNKNOWN SIZE. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE FOLLOW-UP CT DEMONSTRATED A TYPE III ENDOLEAK. THE PHYSICIAN SUSPECTED THE ENDOLEAK MAY BE DUE TO STENT ENLARGEMENT OF THE NAVION DEVICE. THE STENT GRAFT WAS RELIGNED WITH A VALIANT CAPTIVIA AND THE ENDOLEAK RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK WAS DUE TO FAILURE OF THE NAVION DEVICE.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 13150284 ↗
• InjuryOct 1, 2021Adverse 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 THORACIC AORTIC DISSECTION. IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE, THE PATIENT REPORTED THAT THEY HAD UNDERGONE A ANEURYSM RELATED PROCEDURE AT ANOTHER FACILITY. THE PATIENT DECLINED ANY FURTHER FOLLOW UPS. THE PROCEDURE REQUIRED HOSPITALIZATION.  THE SPONSOR ASSESSED THE EVENT WAS RELATED TO STUDY DEVICE, NOT RELATED TO STUDY PROCEDURE AND RELATED TO THE DISSECTION UNDER STUDY.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12560602 ↗
• InjuryAug 26, 2021Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE TAA. TWO YEARS POST IMPLANT THE CORE LAB OBSERVED AN UNKNOWN ENDOLEAK WHILE REVIEWING CTS NO ADDITIONAL CLINICAL SEQUELA WERE REPORTED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 12369570 ↗
• MalfunctionApr 19, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC PENETRATING AORTIC ULCER AND INTRAMURAL HEMATOMA. IT WAS REPORTED A CORE LAB REVIEW IDENTIFIED A TYPE IA ENDOLEAK WITH LOSS OF DISTAL SEAL ON 24M FU CT IMAGES. NO CAUSE OF THE EVENT WAS REPORTED NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686270 ↗
• MalfunctionDec 15, 2020Material Deformation; Material Deformation

  A VALIANT NAVION STENT GRAFT WAS INTENDED TO BE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 150MM THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PACKAGE OF THE GRAFT WAS OPENED AND IT WAS SAID PER TWO SCRUB TECHNICIANS THAT THE HANDLE AT THE BACK OF THE DELIVERY SYSTEM WAS BROKEN IN PIECES AND THE SHAFT WAS BENT. AN ALTERNATIVE DEVICE WAS USED TO CONTINUE THE PROCEDURE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS THE DEVICE BEING BROKEN PRIOR TO ENTERING THE FACILITY. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11010777 ↗
• InjuryNov 23, 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 FIVE DAYS LATER, THE PATIENT ARRIVED TO THE ED WITH ACUTE ABDOMINAL PAIN AND MILD PAIN RADIATING TO THE BACK. HYPERTENSION WAS ALSO NOTED. A CTA WAS PERFORMED WHICH SHOWED STABLE FINDINGS. THE PATIENT RECEIVED MEDICATION FOR THE HYPERTENSION. THE PATIENT WAS ADMITTED FOR OBSERVATION AND THEN WAS DISCHARGED A DAY LATER WITH PAIN MEDICATION. A WEEK LATER AT FOLLOW-UP THE PATIENT REPORTED STILL SOME INTERMITTENT PAIN BUT OVERALL FELT IMPROVED AND THE EVENT WAS DEEMED RESOLVED. THE SITE ASSESSED THE EVENT UNLIKELY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. THE SPONSOR ASSESSED IT AS NOT RELATED TO THE STUDY DEVICE AND RELATED TO THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: High Blood Pressure/ Hypertension; Pain

  MAUDE report 10885092 ↗
• InjurySep 21, 2020Malposition of Device; Malposition of Device

  A VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 280 MM THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE LEFT COMMON CAROTID ARTERY (LCCA) WAS COVERED BY PROXIMAL TIP CAPTURE STENT OF THE NAVION COVERED SEAL DEVICE. THE EVENT WAS TREATED BY IMPLANTING A V12 STENT INTO LCCA ORIGIN FROM THE LEFT BRACHIAL ARTERY RESULTING IN A BRISK FLOW INTO THE LCCA. IT WAS REPORTED THAT THE PATIENT SUFFERED A MICRO-CUTDOWN OF THE LEFT BRACHIAL ARTERY THAT REQUIRED TO IMPLANT A LCCA STENT. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS THAT THE PHYSICIAN REPOSITIONED THE STENT GRAFT PROXIMALLY AFTER THE FULL LENGTH HAD BEEN DEPLOYED, BEFORE THE TIP CAPTURE HAD BEEN RELEASED CAUSED THE FABRIC TO RECEDE BACK OVER THE TIP CAPTURE INNER STENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Intimal Dissection; Occlusion

  MAUDE report 10559670 ↗
• InjuryNov 18, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60 MM DIAMETER THORACIC AORTIC ANEURYSM. THE DIAMETER OF THE PROXIMAL THORACIC AORTA WAS 22 MM. THE DEGREE OF ANGULATION OF THE AORTIC ARCH WAS >90 DEGREES. SIGNIFICANT TORTUOSITY AND MILD CALCIFICATION WAS PRESENT IN THE THORACIC AORTA. MILD CALCIFICATION / TORTUOSITY WAS REPORTED IN OTHER VESSELS. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE DEVICE WOULD NOT NEGOTIATE THE ANGLE OF THE PATIENT'S TYPE III ARCH AND COULD NOT BE DELIVERED TO THE TARGET DEPLOYMENT ZONE. IT WAS ALSO REPORTED THAT THE PATIENT'S ILIAC RUPTURED DURING THE PROCEDURE. A COVERED STENT WAS IMPLANTED AS TREATMENT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO THE PATIENT'S ANATOMY, DUE TO THE TYPE III ARCH. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Perforation of Vessels

  MAUDE report 9335024 ↗
• DeathJun 20, 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 31 MM THORACIC AORTIC DISSECTION. THE PATIENT PRESENTED EMERGENTLY, HAVING AN MI. A CT THEN SHOWED THAT THE PATIENT HAD A TYPE B DISSECTION, WITH MALPERFUSION TO ALL VISCERAL BRANCHES AND THE ENTIRE ABDOMINAL AND ILIACS WERE OCCLUDED/ THROMBOSED. THE PATIENT HAD 2 CORONARY STENTS PLACED PRIOR TO THE TEVAR. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE NAVION WAS PLACED IN THE AORTIC ARCH, INTENTIONALLY COVERING THE SUBCLAVIAN ARTERY AND LANDING JUST DISTAL TO THE LEFT CAROTID. IT WAS REPORTED THAT THE FINAL ANGIOGRAM LOOKED GOOD, WITH TRUE LUMEN EXPANSION. HOWEVER WHEN THE PHYSICIAN WAS CLOSING THE GROIN INCISION, THE PATIENT'S BLOOD PRESSURE DROPPED AND CPR WAS PERFORMED. A TEE WAS PERFORMED AND NO TYPE A RETROGRADE DISSECTION WAS NOTED. AFTER 40 MINUTES OF CPR, THE PATIENT DIED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death

  MAUDE report 8716284 ↗
• InjuryDec 4, 2018Malposition of Device; Malposition of Device

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A PAU. MILD CALCIFICATION WAS OBSERVED AT THE DISTAL IMPLANTATION SITE. IT WAS NOTED THE PATIENT HAD A PREVIOUS DISSECTION WHICH WAS TREATED WITH A HEMI ARCH REPAIR AND A NON MDT STENT GRAFT SYSTEM. IT WAS REPORTED DURING THE INDEX PROCEDURE THE PHYSICIAN ATTEMPTED TO LAND DISTAL EDGE OF THE STENT GRAFT IN AN AREA THAT WAS 2CM PAST THE PAU BUT ALSO LAND SHORT OF AN INTERCOSTAL WHICH WAS APPROX. 3.5 CM PAST THE PAU. THE DISTAL MARKERS ON GRAFT WERE BEYOND THE LEVEL OF THE INTERCOSTAL WHEN DEPLOYMENT BEGAN BUT ENDED UP APPROX. 1 CM PAST THE PAU WHEN DEPLOYMENT WAS COMPLETED. THE PHYSICIAN THEN ELECTED TO IMPLANT AN ADDITIONAL GRAFT TO EXTEND TO TARGET LANDING ZONE. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8128112 ↗