Valiant Navion™ VNMF3737C229TU (UDI 00763000100698)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00763000100698), received between Dec 4, 2018 and Jun 7, 2024 — classified as 3 deaths, 7 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED CT IMAGING TAKEN APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE SHOWED POSTSURGICAL CHANGES OF TEVAR AND AORTOILIAC STENT GRAFT PLACEMENT. THE MAXIMUM THORACIC AORTIC DIAMETER IS 59MM (UNCHANGED FROM PRIOR IMAGING), WITH NO ENDOLEAKS OBSERVED. THE MAXIMUM JUXTARENAL AORTIC ANEURYSM DIAMETER MEASURED APPROXIMATELY MEASURING 53 MM, UNCHANGED FROM PREVIOUS ASSESSMENTS. BILATERAL RENAL AND HEPATIC ARTERY STENTS WERE PLACED AT INTERVALS AND REMAINED PATENT. THERE WAS INTERVAL EMBOLIZATION OF THE SPLENIC ARTERY. CHEST IMAGING REVEALED AN UNCHANGED LEFT PERIFISSURAL GROUND-GLASS NODULE MEASURING 9MM AND A MODERATE HIATAL HERNIA, SIMILAR TO PREVIOUS FINDINGS. ABDOMEN/PELVIS IMAGING SHOWED NO ACUTE FINDINGS IN THE ABDOMEN, AND THERE WAS NO EVIDENCE OF SPLENIC INFARCTS FOLLOWING SPLENIC ARTERY EMBOLIZATION. A REINTERVENTION PROCEDURE WAS PERFORMED AS PER THE PHYSICIAN THE CAUSE OF THE CAUSE OF THE ADVERSE EVENTS IS UNDETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Embolism/Embolus; Insufficient Information

  MAUDE report 19482684 ↗
• DeathSep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. THE PATIENT HAS A HISTORY OF THORACOABDOMINAL ANEURYSM WITH AN ASCENDING ANEURYSM AND ARCH ANEURYSM AND UNDERWENT AORTIC ARCH AND VESSEL DEBRANCHING WITH GRAFTING OF THE ARCH WITH ELEPHANT TRUNK . IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PATIENT HAD MASSIVE BLOOD LOSS AND RECOVERED TO THE VASCULAR ICU. DURING THE POST-OPERATIVE PERIOD THE PATIENT HAD SEVERE ABDOMINAL PAIN AND RETURNED TO THE OR SECONDARY TO SMA THROMBOSIS AND MESENTERIC CHANGES OF THE COLON. THE PATIENT UNDERWENT A COLON RESECTION , REMAINED INTUBATED AND REQUIRED MULTIPLE PRESSORS AND WAS TRANSFERRED TO THE SURGICAL ICU. DURING THE SURGICAL ICU STAY THE PATIENT REQUIRED MULTIPLE PRESSORS AND LARGE VOLUME RESUSCITATION WITHOUT RESPONSE. GIVEN THE PATIENTS POOR PROGNOSIS AND THE UNLIKELIHOOD OF RESPONSE, THE PATIENTS FAMILY ELECTED FOR COMFORT CARE MEASURES AND THE PATIENT PASSED AWAY ON THE SAME DATE FROM A CARDIOPULMONARY ARREST. IT WAS REPORTED THAT CT IMAGING WAS PERFORMED ON THE SAME DATE PRIOR TO THE PATIENTS DEATH . CORELAB HAVE REVIEWED THIS IMAGING AND IDENTIFIED A TYPE II ENDOLEAK . FRACT

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Ischemia; Pain; Thrombosis/Thrombus

  MAUDE report 17787049 ↗
• MalfunctionJul 12, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM ON (B)(6) 2019.  IT WAS REPORTED ON (B)(6) 2021 CT IMAGES REVIEWED BY THE CORE LAB REPORT STENT RING ENLARGEMENT +2.4 MM ON V08168785 WAS OBSERVED. CORE LAB REVIEW OF CT IMAGING FROM (B)(6) 2022 IDENTIFIED PERSISTENT STENT RING ENLARGEMENT (+3.8MM) ON VNMF3737C229TU (V08168785). NEW STENT RING MIGRATION (+8.1MM) WAS OBSERVED ON RING 13 OF VNMF3737C229TU (V08168785). THE MAX AORTIC DIAMETER WAS NOTED AS 55.8MM WITH NO AORTIC ENLARGEMENT IDENTIFIED. NO STENT FRACTURE WAS OBSERVED. THE IMAGING WAS NOTED AS N/A FOR ENDOLEAKS. NO CAUSE AS PER THE PHYSICIAN WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17305043 ↗
• InjuryMar 13, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT  WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A UNKNOWN LENGTH DISSECTION. IT WAS REPORTED THAT CT IMAGING FROM APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE REVEALED AN UNKNOWN ENDOLEAK AND AORTIC ENLARGEMENT. AN UNKNOWN ENDOLEAK WAS ALSO IDENTIFIED AT CT IMAGING FROM 12 MONTHS POST INDEX. CT IMAGING  AT 21 MONTHS IDENTIFIED AORTIC ENLARGEMENT AND THE PRESENCE OF A TYPE IB AND TYPE II ENDOLEAKS. A SECONDARY PROCEDURE WAS PLANNED AND PERFORMED APPROXIMATELY 3.5 MONTHS LATER . CT IMAGING AT 26 MONTHS SHOWED THE PRESENCE OF A TYPE IB ENDOLEAK. AN UNKNOWN ENDOLEAK WAS IDENTIFIED ON CT FROM 32 MONTHS POST INDEX PROCEDURE. NO CAUSE WAS PROVIDED. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 16529737 ↗
• MalfunctionFeb 17, 2023Fracture; Leak/Splash; Migration or Expulsion of Device; Material Deformation; Fracture; Leak/Splash; Migration or Expulsion of Device; Material Deformation

  A VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 57MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT A CT CARRIED OUT APPROXIMATELY 2YERAS AND 11 MONTHS LATER IDENTIFIED  POSSIBLE TYPE IA ENDOLEAK AND POSSIBLE STENT SEPARATION/ENLARGEMENT IN THE PROXIMAL DEVICE.  THE PHYSICIAN SUSPECTS THE DISTAL SEAL ALSO OCCURRED. PER THE PHYSICIAN, THE CAUSE OF THE EVENTS IS DUE TO KNOWN NAVION FAILURE. NO ADDITIONAL SEQUALAE WAS REPORTED  AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16395634 ↗
• DeathNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT  WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A PENETRATING AORTIC ULCER .  IT WAS REPORTED THAT A CT PERFORMED OVER 2 YEARS LATER NOTED AN AORTIC ENLARGEMENT WITH SLOW AND PROGRESSIVE SIZE OF FUSIFORM DILATION OF DESCENDING ABDOMINAL AORTA MEASURING 62MMM.  5 MONTHS PREVIOUSLY THE AORTA SIZE WAS 61MM UP FROM 30 MM AT THE TIME OF IMPLANT.  THE PATIENT DIED 30 MONTHS POST THE IMPLANTED THE CAUSE OF THE ANEURYSM ENLARGEMENT IS UNKNOWN.  THE CAUSE OF DEATH WAS NOT PROVIDED. NO ADDITIONAL SEQUELA WAS REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Aneurysm; Insufficient Information

  MAUDE report 15832913 ↗
• InjurySep 9, 2022Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZE THORACIC AORTIC ANEURYSM.  IT WAS REPORTED ON THE DATE OF THE CT AORTIC ENLARGEMENT WAS OBSERVED. INTERVENTION WAS PERFORMED ABOUT 3 MONTHS LATER, WHERE A FENE STRATED GRAFT WAS IMPLANTED TO TREAT THE TAA. NO CAUSE OF THE EVENT WAS REPORTED. IT WAS CONFIRMED THERE WAS NO OVERSIZING. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm

  MAUDE report 15389242 ↗
• InjuryMay 27, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. IT WAS REPORTED THE PATIENT RETURNED FOR A FOLLOW-UP CT WHERE STENT FRACTURE AND AORTIC ENLARGEMENT WERE NOTED. OUTPOUCHING 6.5CM TOTAL LENGTH; ANTERIOR ASPECT OF DISTAL DESCENDING THORACIC AORTA (6.0CM PREVIOUSLY). AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS DUE TO DISSECTION RELATED LUMINAL DILATION OR A STENT GRAFT INDUCED NEW ENTRY TEAR. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm; Vascular Dissection

  MAUDE report 14520792 ↗
• MalfunctionSep 23, 2021Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN LENGTH AORTIC DISSECTION. CORE LAB REVIEW OF CTS APPROXIMATELY 2 DAYS POST IMPLANT OBSERVED A TYPE IB ENDOLEAK. APPROXIMATELY 2 YEARS AND 2 MONTHS POST IMPLANT STENT GRAFT RING ENLARGEMENT WAS REPORTED. IT WAS REPORTED THERE WERE NO OTHER ISSUES IDENTIFIED LIKE ENDOLEAKS. NO CAUSE OF THE EVENT WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12518106 ↗
• InjuryAug 18, 2021Fracture; Fracture

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60 MM DESCENDING THORACIC ANEURYSM. APPROXIMATELY 19 MONTHS POST INDEX PROCEDURE, IT WAS REPORTED THE PATIENT PRESENTED WITH ANEURYSM PROXIMAL AND DISTAL TO THE STENT GRAFT. A STENT GRAFT FRACTURE WAS ALSO OBSERVED IN THE MID PORTION OF THE NAVION DEVICE. INTERVENTION WAS PERFORMED THE SAME DAY WITH RELINING OF THE NAVION GRAPH AND COVERED FROM THE LSA TO THE CELIAC IN ORDER TO TREAT THE ANEURYSM ON BOTH ENDS OF THE GRAFT. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm

  MAUDE report 12336443 ↗
• InjuryApr 28, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED FOR A 78 MM THORACO-ABDOMINAL ANEURYSM IN A PHYSICIAN MODIFIED FENESTRATED PROCEDURE. APPROXIMATELY 24 MONTHS POST INDEX PROCEDURE, A CT WAS PERFORMED, WHERE IT SHOWED WHAT APPEARED TO BE AN ENDOLEAK TYPE 3 FROM A TEAR IN THE GRAFT. THE EVENT WAS TREATED WITH A 38X38X200 VALIANT CAPTIVIA USED TO RELINE THE STENT GRAFT. THE EVENT IS RESOLVED. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11736777 ↗
• InjuryMar 18, 2020Difficult to Remove; Malposition of Device; Activation, Positioning or Separation Problem; Difficult to Remove; Malposition of Device; Activation, Positioning or Separation Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR REPAIR OF A 50MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE PHYSICIAN DEPLOYED THE DEVICE AT THE TARGET LOCATION BUT DUE TO THE LENGTH OF THE GRAFT USED THE DISTAL END WAS NOT IN THE FIELD OF VIEW ON THE MONITOR OF THE FLUOROSCOPY UNIT. IT WAS THOUGHT THAT THE PHYSICIAN DEPLOYED THE ENTIRE STENT GRAFT BY ROTATING THE DEPLOYMENT HANDLE TO THE END. UNFORTUNATELY THE DEPLOYED HANDLE WAS NOT ROTATED TO THE END AND AS A RESULT THERE WAS APPROXIMATELY 1-2CM THAT REMAINED CONSTRAINED WITHIN THE GRAFT COVER OF THE DELIVERY SYSTEM. WHEN THE PHYSICIAN WENT TO REMOVE THE DELIVERY SYSTEM THAT WAS THOUGHT TO HAVE BEEN PREVIOUSLY COMPLETELY DEPLOYED, THE STENT GRAFT WAS INADVERTENTLY PULLED DOWN FROM THE TARGET LOCATION APPROXIMATELY 4-5CM. THE CONSEQUENCE FROM THIS WAS THE DISTAL END OF THE STENT GRAFT WAS NOW COVERING THE PATIENT'S CELIAC, SMA AND RENAL ARTERIES. AN OPEN THORACOTOMY WAS PERFORMED IN ORDER TO EXPLANT THE VALIANT NAVION AND REPAIR THE THORACIC ANEURYSM AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS USER ERROR. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 9848777 ↗
• MalfunctionJul 25, 2019Difficult to Remove; Difficult to Remove

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 65 MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, DURING REMOVAL OF THE DELIVERY SYSTEM, THE NOSE CONE OF THE DELIVERY SYSTEM SPRUNG FORWARD AND GOT STUCK IN THE GRAFT. THE PHYSICIAN THEN PULLED THE WIRE BACK, TWISTED THE DELIVERY SYSTEM SLIGHTLY AND PULLED THE SYSTEM BACK FORCEFULLY TO REMOVE THE TIP FROM THE STENT GRAFT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO USE ERROR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826573 ↗
• MalfunctionApr 19, 2019Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN DIAMETER THORACIC AORTIC ANEURYSM. THE PATIENT WAS NOTED TO HAVE VERY CALCIFIED VESSELS. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, WHILE DEPLOYING THE BARE METAL SPRINGS AFTER DEPLOYMENT OF THE ENTIRE STENT GRAFT, THE TIP RELEASE HANDLE BROKE. THE STENT GRAFT HAD BEEN DEPLOYED PER IFU BY ROTATION OF THE BLUE HANDLE WITHOUT ANY RESISTANCE NOTED, UNTIL THE TIP CAPTURE WOULD NOT RELEASE. AT THIS POINT THE PHYSICIAN AGGRESSIVELY PULLED THE TIP RELEASE HANDLE AND IT BROKE. IT WAS NOTED THAT IFU PROTOCOL WAS USED FOR THE TIP CAPTURE RELEASE BAILOUT AND THE DEPLOYMENT WAS COMPLETED SUCCESSFULLY. IT WAS CONFIRMED THAT FORWARD PRESSURE WAS NOT RELIEVED PRIOR TO TIP RELEASE. THE CAUSE OF THE EVENT IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT'S TORTUOUS ANATOMY AND BLOOD PRESSURE MAY HAVE BEEN A FACTOR. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8530781 ↗
• MalfunctionJan 31, 2019Malposition of Device; Malposition of Device

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 35 MM THORACIC AORTIC ANEURYSM. THE PATIENT PREVIOUSLY HAD A CAROTID-SUBCLAVIAN BYPASS. ACCESS VESSELS WERE SMALL (LEFT AND RIGHT ILIAC BOTH 7MM), SO THE PHYSICIAN OPTED FOR THE VNCF3737C229TU DEVICE. A VNMC3737C182TU STENT GRAFT WAS ALSO SUCCESSFULLY IMPLANTED DURING THE PROCEDURE. THE PATIENT HAD BILATERAL EXTERNAL ILIAC STENTS AND A LEFT COMMON ILIAC STENT PREVIOUSLY IMPLANTED. THERE WAS STENOSIS AT THE ORIGIN OF THE RIGHT COMMON ILIAC. WHEN THE VNCF3737C229TU DEVICE WAS IN POSITION ON THE OUTER CURVE, THE PHYSICIAN STARTED TO DEPLOY THE DEVICE AND PULLED THE RAPID DEPLOYMENT TRIGGER. WHEN THE PHYSICIAN THOUGHT THAT THEY HAD REACHED THE END OF THE DELIVERY SYSTEM, IT WAS NOTED THAT THE DEVICE HAD NOT FULLY DEPLOYED AND THEY THEN PULLED THE HANDLE DOWN FURTHER. IT WAS REPORTED THAT THIS MAY HAVE BEEN THE CAUSE OF THE INACCURATE DEPLOYMENT. THE DEVICE WAS DEPLOYED APPROXIMATELY 0.5 CM SHORT OF THE INTENDED LANDING ZONE. ANGIOGRAM SHOWED THAT THE ANEURYSM WAS SEALED, AND THE SUBCLAVIAN WAS COVERED, AS INTENDED. THE PHYSICIAN WAS HAPPY WITH THE SEAL AND DECIDED TO COMPLETE THE PROCEDUR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8292050 ↗
• MalfunctionDec 31, 2018Leak/Splash; Difficult to Remove; Deformation Due to Compressive Stress; Leak/Splash; Difficult to Remove; Deformation Due to Compressive Stress

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 64MM THORACIC ANEURYSM (275MM IN LENGTH). THE DIAMETER OF THE PROXIMAL NECK MEASURED 28MM. SEVERE VESSEL TORTUOSITY WAS NOTED. IT WAS REPORTED DURING THE INDEX PROCEDURE THE GRAFT WAS ADVANCED TO THE L COMMON CAROTID. THE GRAFT WAS THEN DEPLOYED AND THE TIP CAPTURE HANDLE WAS RELEASED HOWEVER THE TIP CAPTURE MECHANISM BECAME STUCK ON ONE BARE SPRING OR POSSIBLY STUCK ON THE PROXIMAL EDGE OF THE FABRIC. THE DEVICE WAS ADVANCED AND WITHDRAWN SEVERAL TIMES BEFORE THE TIP CAPTURE MECHANISM FINALLY RELEASED. THE PROXIMAL EDGE OF FABRIC APPEARED TO BE AFFECTED IN TURN FROM THIS MOTION AND A TYPE IA OR TYPE II ENDOLEAK WAS SUSPECTED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8206356 ↗
• DeathDec 4, 2018Adverse 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 68MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT CT SHOWED THAT THE THORACIC AORTA HAD A DISSECTION DISTAL TO THE END OF THE DISTAL END OF THE STENT GRAFT AND THAT THE AORTA AND VISCERAL VESSELS DISTALLY WERE ALL OCCLUDED. THE PATIENT HAS NOT AND WILL NOT RECEIVE TREATMENT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Anemia; Gastrointestinal Hemorrhage; Intimal Dissection; Occlusion

  MAUDE report 8129469 ↗