Valiant Navion™ VNMC3428C207TU (UDI 00763000101237)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000101237), received between May 16, 2019 and Apr 14, 2023 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC ANEURYSM . IT WAS REPORTED THAT THREE YEARS AND FIVE MONTHS LATER, THE PATIENT PRESENTED EMERGENTLY COMPLAINING OF CHEST PAIN. A CT SCAN WAS TAKEN AND  REVEALED CONCERN FOR ENDOLEAK OF THE DESCENDING THORACIC AORTA. REPEAT CTA  PERFORMED ON (B)(6) 2022 WAS SIGNIFICANT FOR INCREASING ANEURYSMAL CHANGE OF THE JUNCTION OF THE ARCH OF THE AORTA AND DESCENDING THORACIC AORTA. ENLARGEMENT ANEURYSM SAC SIZE MID DESCENDING THORACIC AORTA APPROACHING 9 CM IN GREATEST TRANSVERSE DIMENSION. THE ENDOLEAK WAS MOST LIKELY RELATED TO THE PROXIMAL ATTACHMENT SITE. THE PATIENT WAS TRANSFERRED TO A DIFFERENT FACILITY FOR ENDOVASCULAR REPAIR AND COVERAGE OF LEFT CAROTID ARTERY. A 240MM NON-MEDTRONIC STENT GRAFT WAS IMPLANTED  WITH THE PROXIMAL GRAFT COVERING THE LEFT COMMON CAROTID ARTERY. PATENCY OF THE LEFT COMMON CAROTID  ARTERY WAS MAINTAINED WITH A FENESTRATED NON-MEDTRONIC STENT. THE PATIENT ALSO UNDERWENT LEFT COMMON CAROTID ARTERY TO LEFT SUBCLAVIAN BYPASS AND HAD A COMPLICATION OF A STROKE FROM THE PROCEDURE AFFECTING THE RIGHT ARM. FOLLOW UP CT FROM T HREE MONTHS AFTER REVEALED NO EVIDEN

  Patient problems: Chest Pain; Stroke/CVA

  MAUDE report 16742868 ↗
• MalfunctionDec 16, 2022Material Deformation; Material Deformation

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN LENGTH DISSECTION. CORELAB HAVE REVIEWED CT IMAGING AND HAVE OBSERVED STENT RING ENLARGEMENT OF +2.1MM ON THE STENT GRAFT (B)(4). NO ENDOLEAK,  FRA CTURE, OR STENT RING MIGRATION WERE OBSERVED. 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 15996244 ↗
• MalfunctionAug 4, 2022Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM.  IT WAS REPORTED THAT A FOLLOW UP CT APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE SHOWED NO OBSERVATIONS. CORE LAB REVIEW OF IMAGING FROM (B)(6) 2022 IDENTIFIED A TYPE IA ENDOLEAK AND STENT RING ENLARGEMENT +2MM WAS OBSERVED ON VNMC3428C207TU ((B)(4)).  NO CAUSE OF THE TYPE IA ENDOLEAK AND STENT RING ENLARGEMENT 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 15163958 ↗
• InjuryJan 7, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC ANEURYSM. THE PATIENT HAD ADDITIONAL DEVICES IN THE DESCENDING THORACIC AORTA WITH COVERAGE OF THE CELIAC. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE AN INTERVENTION PROCEDURE FOR THE TREATMENT OF ANEURYSM EXPANSION DUE TO A TYPE III ENDOLEAK WAS PERFORMED.  TWO NON-MDT ENDOGRAFT DEVICES WERE PLACED AND THE ENDOLEAK WAS RESOLVED. NO CAUSE OF THE TYPE III ENDOLEAK HAS BEEN PROVIDED.  NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm; Mitral Valve Insufficiency/ Regurgitation; Stroke/CVA; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 13190181 ↗
• InjuryJan 7, 2022Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN UNKNOWN THORACIC ENDOVASCULAR PROCEDURE. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE INTERVENTION WAS PERFORMED DUE STENT GRAFT MIGRATION AND A TYPE IA ENDOLEAK. THE PHYSICIAN EXTENDED AND RE-LINED THE PROXIMAL ENDOGRAFT USING TWO NON-MDT STENT GRAFTS. DURING THE INTERVENTION THERE WAS AN ACCESS SITE COMPLICATION: PERCUTANEOUS CLOSURE DEVICE FAILURE REQUIRING DIRECT FEMORAL ARTERY REPAIR.   AS PER THE PHYSICIAN THE CAUSE OF THE MIGRATION AND TYPE IA ENDOLEAK ARE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Epistaxis; Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 13190076 ↗
• InjurySep 8, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE.  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE. A CT WAS PERFORMED WHERE A ENDOLEAK WAS IDENTIFIED. THE PATIENT WAS THEN TRANSFERRED TO ANOTHER FACILITY FOR TREATMENT. INTERVENTION WAS PERFORMED WHERE THE NAVION STENT GRAFT WAS RELINED WITH A VALIANT CAPTIVIA STENT GRAFT.  IT WAS SAID IT COULD NOT BE DETERMINED IF THE TYPE OF ENDOLEAK WAS A TYPE IA OR TYPE IIIB ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12439343 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: Vascular Dissection

  MAUDE report 11782659 ↗
• MalfunctionFeb 25, 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 IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 32-36 MM THORACIC AORTIC DISSECTION DISTAL TO LSA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, VNMC3428C207TU WAS PLACED AT THE LEVEL OF THE LSA FOLLOWED BY VNMC2828C90TU TO LEVEL OF THE CELIAC ARTERY. FINAL ANGIOGRAM WAS PERFORMED, WHERE IT WAS NOTED THAT THE FALSE LUMEN WAS FILLING THROUGH, WHICH WAS BELIEVED TO BE THE GRAFT. GRAFT POROSITY ON THE DISSECTION WAS REPORTED. THE FINDINGS SHOWED NO CONTRAST OUTSIDE OF THE GRAFT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378406 ↗
• InjuryNov 23, 2020Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 74MM THORACIC AORTIC ANEURYSMS. THE MONTH PREVIOUSLY THE PATIENT HAD A AORTIC ASCENDING REPAIR UTILIZING THE ELEPHANT TRUNK TECHNIQUE. A FOLLOW-UP CT JUST OVER FIVE WEEKS POST THE TEVAR PROCEDURE SHOWED NO ENDOLEAKS BUT THE ANEURYSM HAD GROWN FROM 74MM TO 80MM. IT WAS REPORTED THE PATIENT CALLED COMPLAINING OF BACK PAIN AND SCANS PERFORMED OVER 3 MONTHS POST THE INDEX PROCEDURE SHOWED THE ANEURYSM SIZE WAS THE SAME BUT CONTRAST WAS SEEN IN THE SAC. IT WAS MENTIONED THAT IT WAS THOUGHT TO BE A POSSIBLE TYPE II ENDOLEAK BECAUSE A TYPE I ENDOLEAK COULD NOT BE SEEN. INTERVENTION WAS PERFORMED VIA OPEN REPAIR, A LOT OF CLOTS WERE IDENTIFIED BUT THERE WAS NO TYPE I OR TYPE II ENDOLEAK SEEN. THE PHYSICIAN NOTED THERE WAS HOLES IN THE GRAFT FABRIC WHERE THE SUTURES HOLD THE NITINOL STENTS TO THE GRAFT FABRIC. ONE OF THE HOLES WAS ¿SPRAYING¿ BLOOD REPORTEDLY. IT WAS ALSO NOTED THE VALIANT STENT GRAFT DID NOT HAVE A LAYER OF TISSUE GROWTH ON IT LIKE THE ELEPHANT TRUNK GRAFT DID. THE VALIANT NAVION STENT GRAFT WAS THEN EXPLANTED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS HOLES IN THE GRAFT DUE TO AN UNKNOWN RE

  Patient problems: Pain

  MAUDE report 10885358 ↗
• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A >300MM THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT THE PATIENT PRESENTED 31 DAYS LATER, WITH SYMPTOMS OF INCREASING CHEST PAIN AND DIZZINESS. A CTA PERFORMED SHOWED A TYPE A DISSECTION. INTERVENTION WAS PERFORMED THE NEXT DAY, THE PATIENT UNDERWENT A HEMI-ARCH REPLACEMENT SURGICAL PROCEDURE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND REPORTED AN UNSTABLE AORTA. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Dizziness; Intimal Dissection; Pain

  MAUDE report 10282284 ↗
• InjuryMar 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 200MM AORTIC THORACIC DISSECTION. IT WAS REPORTED FIVE MONTHS LATER A RETEROGRADE TYPE A DISSECTION OCCURRED AND THE PATIENT RECEIVED TREATMENT TWO DAYS LATER. THE DETAILS OF THE TREATMENT THAT THE PATIENT RECEIVED ARE UNKNOWN. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Intimal Dissection

  MAUDE report 9852165 ↗
• InjuryMay 16, 2019Malposition of Device; Malposition of Device

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 200MM THORACIC DISSECTION. IT WAS REPORTED DURING THE INDEX PROCEDURE WHEN THE PHYSICIAN ENGAGED IN STENT GRAFT DEPLOYMENT, UPON TIP-CAPTURE RELEASE THE PROXIMAL EDGE OF THE GRAFT MOVED BACK MISSING THE INTENDED TARGET. A VALIANT NAVION PROXIMAL EXTENSION WAS IMPLANTED COVERING THE NECESSARY DISSECTED AORTA. 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 8615143 ↗