Valiant Navion™ VNMC3434C223TU (UDI 00763000101039)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00763000101039), received between Dec 19, 2018 and Jun 12, 2026 — classified as 10 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (12 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 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Leak/Splash; Migration or Expulsion of Device

  IT WAS REPORTED THAT, DURING A FOLLOW-UP VISIT APPROXIMATELY 12.5 YEARS AFTER TREATMENT FOR AORTIC DISSECTION WITH TWO VALIANT NAVION STENT GRAFTS, COMPUTED TOMOGRAPHY REVEALED DISTAL MIGRATION OF THE PROXIMAL STENT GRAFT, WITH ANEURYSMAL DILATION OF THE THORACIC AORTA AT THE TRANSVERSE ARCH. THE PROXIMAL END OF THE STENT GRAFT DOES NOT ADEQUATELY APPOSE THE AORTIC WALL AND IS POSITIONED WITHIN THE THORACIC AORTIC ANEURYSM, RESULTING IN A TYPE IA ENDOLEAK. THE PROXIMAL DEVICE THAT HAS MIGRATED APPEARS TO BE THE VNMC3434C223TU. FUTURE INTERVENTION CONSISTING OF A RIGHT COMMON CAROTID ARTERY TO LEFT COMMON CAROTID ARTERY BYPASS, LIGATION OF THE LEFT COMMON CAROTID ARTERY, AND PROXIMAL EXTENSION OF THE EXISTING STENT GRAFT TO THE INNOMINATE ARTERY HAS BEEN PLANNED BUT NOT YET SCHEDULED. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm expansion

  MAUDE report 25483138 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DISTAL STENT RING OF THE 37MM NAVION STENT GRAFT BECAME DISCONNECTED FROM THE FABRIC DURING TREATMENT FOR AORTIC DISSECTION. THE NAVION PRODUCT WAS IDENTIFIED AS PART OF THE SAFE-N-RECALL. THE EVENT WAS DISCOVERED THROUGH COMPUTED TOMOGRAPHY APPROXIMATELY 5 YEARS AND 2 MONTHS POST-INDEX PROCEDURE , WHICH REVEALED THAT THE DISTAL STENT RING HAD AN AVERAGE DIAMETER OF 39.2MM X 44.8MM, INDICATING DISCONNECTION FROM THE FABRIC. THERE WAS NO CALCIFICATION NOTED AT THE DISTAL LANDING ZONE, HOWEVER THE DISTAL STENT IS LOCATED IN A DEGENERATED AREA OF THE DESCENDING THORACIC AORTA. NO ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN IS CONCERNED THAT THE STENT RING WOULD MIGRATE PROXIMALLY WHICH COULD CAUSE AN ENDOLEAK. THE REMAINING SEGMENT OF THE DESCENDING THORACIC AORTA HAS REMODELED. ADDITIONALLY, THE AORTIC DIAMETER AT THE PROXIMAL EDGE OF THE VALIANT NAVION (VNMC3434C223TU) NOW AVERAGES 37.8MM, AND AT THE LEFT SUBCLAVIAN ARTERY (LSA), IT AVERAGES 36.2MM. IT WAS CONFIRMED THAT THE PROXIMAL STENT RING IS COMPLETELY INTACT. THERE IS MILD AORTIC DEGENERATION AT THE PROXIMAL EDGE OF THIS STENT, WHERE THE FIRST STENT RING OF THE 34 MM DEVICE HAD LANDED AS THE AORTA HAS GROW

  Patient problems: Aneurysm; Insufficient Information

  MAUDE report 22911023 ↗
• MalfunctionOct 27, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM ON (B)(6) 2020. IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING FROM 21 MONTHS POST THE INDEX PROCEDURE, CORELAB IDENTIFIED A TYPE IA ENDOLEAK ON VNMC3434C223TU (V29914821) AND A TYPE IB ENDOLEAK WAS OBSERVED ON VNMC4040C95TU (V29894270). NO STENT RING ENLARGEMENT WAS OBSERVED. THE MAX AORTIC DIAMETER WAS NOTED AS 65.8MM. THE IMAGING WAS NA FOR AORTIC ENLARGEMENT. THE IMAGING WAS NOTED AS NON EVALUABLE ON ALL DEVICES FOR STENT FRACTURES AND STENT RING MIGRATION DUE TO DEVICE OVERLAPS. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAKS ARE UNDETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18019670 ↗
• MalfunctionJun 29, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN LENGTH DISSECTION .  IT WAS REPORTED THAT A CT WAS TAKEN. CORELAB HAVE REVIEWED THIS IMAGING AND IDENTIFIED A NEW TYPE IA ENDOLEAK ON THE STENT GRAFT WITH SN (B)(6) . STENT RING ENLARGEMENT OF +2.1MM WAS NOTED ON THE STENT GRAFT (B)(6). NO FRACTURE OR STENT RING MIGRATION WERE NOTED. THE MAXIMUM AORTIC DIAMETER WAS 47.9MM. N/A FOR 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 17223524 ↗
• InjuryMay 5, 2023Fracture; Leak/Splash; Detachment of Device or Device Component; Fracture; Leak/Splash; Detachment of Device or Device Component

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 49MM THORACIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT SHOWED A STENT STRUT FRACTURE/SUTURE SEPARATION WHICH HAS CAUSED A TYPE IIIB ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE FRACTURE/ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 16875333 ↗
• MalfunctionFeb 28, 2023Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN AN ENDOVASCULAR PROCEDURE.  CORELAB REVIEW OF CT IMAGING DATED IDENTIFIED A TYPE IIIB ENDOLEAK ON THE STENT GRAFT WITH SN (B)(4). FRACTURE AND STENT RING MIGRATION WERE NOT EXAMINABLE DUE TO OVERLAPS. STENT RING ENLARGEMENT OF + 2.9MM WAS NOTED ON THE SAME STENT GRAFT. THE MAXIMUM AORTIC DIAMETER WAS 81.3MM. NO AORTIC ENLARGEMENT WAS NOTED.  CT IMAGING SEVEN MONTHS LATER CONFIRMED THE PERSISTENT TYPE IIIB ENDOLEAK ON STENT GRAFT V08173031 WITH + 2.7MM STENT RING ENLARGEMENT  PERSISTENT ON THE SAME STENT GRAFT.  FRACTURE AND STENT RING MIGRATION WERE NOT EXAMINABLE DUE TO OVERLAPS. THE MAXIMUM AORTIC DIAMETER WAS 83.3MM.  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 16451223 ↗
• MalfunctionJan 25, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WERE IMPLANTED FOR THE TREATMENT OF AN UNKNOWN LENGTH DISSECTION. IT WAS REPORTED APPROXIMATLEY 1 YEAR POST THE INDEX PROCEDURE, CT IMAGING IDENTIFIED  AN UNKNOWN ENDOLEAK.  NO CAUSE PROVIDED. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16239280 ↗
• MalfunctionDec 7, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN LENGTH DISSECTION.  IT WAS REPORTED ON THE DATE OF THE CT ABOUT 2 MONTHS LATER, THE SITE IDENTIFIED A TYPE IA ENDOLEAK.  NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15930411 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 (B)(6) 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 SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Vascular Dissection

  MAUDE report 15922626 ↗
• InjuryDec 1, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA.  IT WAS REPORTED THAT A CT WAS PERFORMED OVER 2.5 YEARS LATER, CORELAB HAVE REVIEWED AND OBSERVED A TYPE IB ENDOLEAK. AORTIC ENLARGEMENT OF +16MM WAS ALSO OBSERVED WHEN COMPARED TO PREVIOUS IMAGING TAKEN. NO FRACTURE OR STENT RING ENLARGEMENT/MIGRATION WAS NOTED.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 15892818 ↗
• MalfunctionNov 16, 2022Migration or Expulsion of Device; Detachment of Device or Device Component; Migration or Expulsion of Device; Detachment of Device or Device Component

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN LENGTH DISSECTION  IT WAS REPORTED A CTA PERFORMED ON AN UNKNOWN DATE 7 MONTHS LATER , SHOWED PROXIMAL STENT MIGRATION DISTALLY 20MM WITH AN AREA OF DEGENERATION BETWEEN THE LEFT CAROTID AND STENT OF 45MM. THE MAXIMUM AORTIC DIAMETER WAS 5CM. THE PATIENT WAS FEELING WELL BUT HAD ELEVATED BLOOD PRESSURE. IT IS UNKNOWN WHICH STENT GRAFT MIGRATED.  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 15805509 ↗
• MalfunctionOct 21, 2022Material Deformation; Material Deformation

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION. IT WAS REPORTED APPROXIMATLEY 2 YEARS POST THE INDEX PROCEDURE, CORE LAB REVIEW OF CT IMAGING FROM IDENTIFIED STENT RING ENLARGEMENT OF 1.8MM ON THE NAVION GRAFT VNMC3434C223TU (B)(4). NO ENDOLEAK, STENT FRACTURE OF STENT RING MIGRATION WAS OBSERVED. THE IMAGING WAS NOTED AS NA FOR AORTIC ENLARGEMENT. PER THE PHYSICIAN THE CAUSE OF THE STENT RING ENLARGEMENT IS UNDETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15649421 ↗
• MalfunctionAug 10, 2022Material Deformation; Material Deformation

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA. IT WAS REPORTED THAT CORELAB REVIEWED CT'S FROM APPROXIMATELY 3 YEARS AND 1 MONTH POST INDEX PROCEDURE AND RING ENLARGEMENT OF +1.4MM WAS NOTED ON THE STENT GRAFT VNMC3434C223TU SN (B)(4). NO STENT RING DISPLACEMENT (STENT RING MIGRATION), ENDOLEAK OR FRACTURE WAS NOTED. FRACTURE WAS NOT EXAMINABLE ON THE STENT GRAFTS WITH SERIAL NUMBERS (B)(4) DUE TO DEVICE OVERLAPS. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15200954 ↗
• InjuryNov 19, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC DISSECTION WHICH WAS 40MM TO THE ILIAC TRUNK . IT WAS REPORTED DURING A FOLLOW-UP CT 16 MONTHS LATER THAT A TYPE IB ENDOLEAK WAS OBSERVED. ABOUT 3 MONTHS LATER THE PATIENT UNDERWENT AN EMBOLISATION FOR TREATMENT OF THE ENDOLEAK, NO ADDITIONAL DEVICES WERE IMPLANTED AND THE ENDOLEAK RESOLVED.  AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IB ENDOLEAK CANNOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm; Aneurysm expansion; Insufficient Information; Thrombosis/Thrombus

  MAUDE report 12842970 ↗
• InjuryMay 6, 2021Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED FOR A 489 MM THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT APPROX. 1 YEAR AND 10 MONTHS POST PROCEDURE, DURING PATIENT'S FOLLOW-UP, PROXIMAL MIGRATION OF THE STENT GRAFT (VNMC3434C223TU) AND AN ENDOLEAK TYPE 1A INTO FALSE LUMEN WAS NOTED. MOREOVER, SINE (STENT GRAFT-INDUCED NEW ENTRY) AT DISTAL EDGE OF STENT GRAFT (VNMC3428C207TU) WAS OBSERVED. 2.5 MONTHS LATER, A PROXIMAL EXTENSION (34X34X100) WAS IMPLANTED TO TREAT THE ENDOLEAK AND DISTAL EXTENSION (34X30X150) WAS PLACED TO COVER THE OBSERVED SINE. THE EVENTS ARE NOW RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11782689 ↗
• InjuryApr 29, 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 WAS IMPLANTED FOR AN ANEURYSMAL DISSECTION. IT WAS REPORTED THAT APPROXIMATELY 22 MONTHS POST INDEX PROCEDURE, A CT WAS PERFORMED AFTER THE PATIENT COMPLAINED OF CHEST PAIN, WHERE AN ENDOLEAK TYPE 3 B WAS NOTED. AN INTERVENTION WAS PERFORMED ON THE NEXT DAY, WHERE THE VALIANT NAVION STENT GRAFT (VNMC3434C223TU) WAS RELINED WITH 37-200 CTAG AND EXTENDED TO THE EDGE OF THE SECOND VALIANT NAVION STENT GRAFT (VNMC4034C200TU) WITH 37-150 CTAG. ANGIOGRAPHY WAS PERFORMED AND CONFIRMED THAT THE ENDOLEAK 3B WAS RESOLVED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS DEVICE FAILURE. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 11744188 ↗
• InjuryNov 9, 2020Adverse 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 260 MM THORACIC AORTIC DISSECTION. IT WAS REPORTED DURING A FOLLOW-UP, APPROXIMATELY 09 MONTHS POST INDEX PROCEDURE, IT WAS NOTED THAT A DISSECTION CONTINUES BEYOND THE STENT GRAFT, DISTAL TO THE EXISTING DEVICE. IT WAS STATED THAT A VALIANT NAVION EXTENSION WAS IMPLANTED TO TREAT THE EVENT ON THE NEXT DAY. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Intimal Dissection

  MAUDE report 10808537 ↗
• MalfunctionAug 27, 2020Difficult to Remove; Difficult to Remove

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 200MM THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THAT THE TIP WAS DIFFICULT TO RECAPTURE AND THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE. THE STIFF WIRE WAS THEN RETRACTED BACK AS FAR AS THE "NOSE CONE" WHICH ALLOWED THE DELIVERY SYSTEM TO BE REMOVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND NOTED A "S" SHAPE IN THE PATIENTS DISTAL ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10459030 ↗
• MalfunctionFeb 24, 2020Leak/Splash; Leak/Splash

  A VALIANT NAVION VNMC3434C223TU STENT GRAFT WAS INTENDED TO BE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A THORACIC ULCER. IT WAS NOTED THAT THIS DEVICE WOULD NOT DE-AIR (FLUSH) AFTER MULTIPLE ATTEMPTS. THIS USE OF THIS DEVICE WAS THEN ABANDONED. ANOTHER VALIANT NAVION VNMC3737C223TU (B)(4) WAS INTENDED TO BE IMPLANTED IN THIS PROCEDURE BUT IT WAS FOUND THIS DEVICE ALSO WOULD NOT DE-AIR AFTER MULTIPLE ATTEMPTS AND THE PATIENT HAD A REPLACEMENT NAVION STENT GRAFT IMPLANTED INSTEAD. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9743924 ↗
• InjuryJan 9, 2020Adverse 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 THORACIC AORTIC ULCER. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE AN ACUTE INCIDENCE OF SPINAL CORD ISCHEMIA OCCURRED. THE ISCHEMIA WAS RESOLVED AFTER RAISING THE PATIENT'S BLOOD PRESSURE AND A SPINAL DRAIN. THE PATIENT IS DOING WELL AND IS SYMPTOM FREE. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Ischemia

  MAUDE report 9568537 ↗
• InjuryDec 19, 2018Malposition of Device; Malposition of Device

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR AN UNKNOWN THORACIC ENDOVASCULAR TREATMENT. THE DIAMETER OF THE PROXIMAL THORACIC AORTA WAS 37MM AND THE DEGREE OF ANGULATION WAS 40 DEGREES. THE PATIENT ALSO HAD A RIGHT SIDED ARCH WITH KOMMERELL'S DIVERTICULA. IT WAS REPORTED THAT DURING DEPLOYMENT, THE FIRST NAVION DEVICE WAS NOT DELIVERED TO ITS INTENDED LOCATION AND THE DEVICE APPEARED TO RIDE UP TOWARDS THE HEAD, WITHOUT ACTUAL MOVEMENT OF THE DEVICE. THE DEVICE WAS PULLED BACK DOWN TO AVOID COVERAGE OF THE CAROTID. AN ADDITIONAL VALIANT NAVION STENT GRAFT WAS IMPLANTED DUE TO THE DIFFICULTY EXPERIENCED WITH THE FIRST DEVICE. IT WAS NOTED THERE WAS NO RAPID RIGHT VENTRICULAR PACING MAINTAINED DURING DEPLOYMENT. ADENOSINE WAS USED FOR PROCEDURAL HYPOTENSION AND TO MAINTAIN FORWARD PRESSURE DURING DEPLOYMENT AND THE DELIVERY SYSTEM AND GUIDEWIRE WERE FULLY APPOSED TO THE GREATER CURVATURE OF THE AORTA DURING DEPLOYMENT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO THE HIGH ANGLE OF THE AORTIC ARCH. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8179463 ↗