Valiant Navion™ VNMC3737C90TU (UDI 00763000101053)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000101053), received between Aug 2, 2019 and Apr 12, 2024 — classified as 6 deaths, 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• DeathApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS (VNMC3737C90TU / VNMC3737C182TU) WERE IMPLANTED DURING THE REINTERVENTION OF A PRIOR THORACIC AORTIC REPAIR. THE PATIENT HAD 2 EXISTING VALIANT CAPTIVIA STENT GRAFTS IMPLANTED 5 YEARS PREVIOUSLY. IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING TAKEN APPROXIMATELY 2 YEARS POST THE NAVION IMPLANT IDENTIFIED A NEW TYPE II ENDOLEAK. THE MAX AORTIC DIAMETER WAS NOTED AS 71.MM. THE IMAGING WAS NA FOR AORTIC ENLARGEMENT. NO STENT RING ENLARGEMENT OR STENT RING MIGRATION WAS OBSERVED. THE IMAGING WAS NOTED AS NON EVALUABLE FOR STENT FRACTURES. IT WAS NOTED ON IMAGE REVIEW - UNABLE TO FULLY IDENTIFY NAVION DEVICES, BUT LARGEST STRUT MEASURED AND SRE FOR BOTH 37X37 DEVICES.  IT WAS REPORTED THE PATIENT EXPIRED ON AN UNKNOWN DATE. THE CAUSE OF THE TYPE II ENDOLEAK AND DEATH IS UNDETERMINED.

  Patient problems: Insufficient Information

  MAUDE report 19094721 ↗
• DeathMay 30, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A ULCER. IT WAS REPORTED A CT APPROXIMATELY 22 MONTHS POST IMPLANT OBSERVED A TYPE IA AND TYPE IB ENDOLEAK ALONG WITH AORTIC ENLARGEMENT.  IT WAS REPORTED THE PATIENT DIED APPROXIMATELY 6 MONTHS POST CT.   NO CAUSE OF THE ENDOLEAKS OR PATIENT DEATH WERE PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 17021267 ↗
• MalfunctionJan 25, 2023Leak/Splash; Material Deformation; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Material Deformation; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED AS PART OF A RE-INTERVENTION FOR A PRIOR TEVAR, ALONG WITH A NON MDT AORTIC ROOT GRAFT IN THE REPAIR OF A TYPE A AORTIC DISSECTION.  IT WAS REPORTED ON THE DATE OF THE CT OVER A MONTH LATER, THE PATIENT WAS FOUND TO HAVE A TYPE IA ENDOLEAK. THIS TYPE IA ENDOLEAK WAS ALSO SEEN ON SUBSEQUENT 2 MONTHS LATER AND ANOTHER 2 YEARS LATER.  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 16239919 ↗
• InjuryJan 16, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA .  IT WAS REPORTED ON THE DATE OF A CT 7 MONTHS LATER , SHOWED A TYPE II AND TYPE IB ENDOLEAK.  2 DAYS LATER, A REPAIR OF THE ENDOLEAK WAS PERFORMED WHERE A NON MDT WAS IMPLANTED AND ALSO EMBOLIZATION WAS PERFORMED. 10 DAYS LATER , ANOTHER CT PERFORMED HAS NO OBSERVATIONS. A MONTH LATER A CR SHOWED A TYPE II ENDOLEAK AND AGAIN A CT THE FOLLOWING YEAR CONFIRMED THE PERSISTENT TYPE II ENDOLEAK.  PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 16173183 ↗
• DeathOct 26, 2022Leak/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 FOR THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. IT WAS REPORTED THAT CORELAB REVIEW OF CT'S CARRIED OUT 3 DAYS POST-IMPLANT IDENTIFIED A TYPE IB ENDOLEAK ON DEVICE VNMC3737C90TU (SN (B)(4)). THERE WAS NO FRACTURES, STENT RING ENLARGEMENT OR  STENT RING MIGRATION OBSERVED. IT WAS NOTED THAT THE DEVICE IMPLANT ORDER WAS UNABLE TO BE CONFIRMED BY THE SITE. IT WAS REPORTED THE PATIENT DIED ON A AN UNKNOWN DATE APPROXIMATELY 7 MONTHS POST THE INDEX PROCEDURE LIKELY FROM ANEURYSM RUPTURE. IT WAS STATED  THAT THE DEVICE CONSTRUCTION WAS ATYPICAL WITH PARALLEL GRAFTS (SNORKELS, CHIMNEYS, ETC) AND  SHOULD NOT BE CONSIDERED DEVICE FAILURE. NO ADDITIONAL CLINICAL SEQUELAE WAS REPORTED AND THE PATIENT EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 15672063 ↗
• InjuryOct 6, 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 WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. 2 ADDITIONAL VALIANT NAVION GRAFTS WERE IMPLANT ED ON 8 MONTHS POST THE INDEX PROCEDURE. IT WAS REPORTED ON AN UNKNOWN DATE, DURING FOLLOW UP CT, CONTRAST WAS NOTED IN THE PROXIMAL DESCENDING THORACIC AORTA. A SMALL PSEUDOANEURYSM IS ARISING FROM THE ASCENDING THORACIC AORTIC GRAFT BUT IS STABLE IN APPEARANCE. PER THE PHYSICIAN THE CAUSE OF THE PSEUDOANEURYSM IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pseudoaneurysm

  MAUDE report 15557304 ↗
• InjuryMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 13755895 ↗
• MalfunctionMar 2, 2022Fracture; Leak/Splash; Material Deformation; Fracture; Leak/Splash; Material Deformation

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC DISSECTION .  IT WAS REPORTED THE PATIENT RETURNED FOR A CT WHERE A TYPE III ENDOLEAK WAS OBSERVED.  NO CAUSE OF THE TYPE III ENDOLEAK 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 13652098 ↗
• DeathNov 24, 2021Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC ANEURYSM OF AN UNKNOWN SIZE. A LEFT SUBCLAVIAN TRANSPOSITION, SUBSEQUENT TO THE DEPLOYMENT OF VALIANT NAVION WAS ALSO PERFORMED. IT WAS REPORTED DURING A FOLLOW-UP CT ABOUT 18 MONTHS LATER THAT A TYPE IA ENDOLEAK WAS NOTED ON ONE OF THE GRAFTS. IT IS UNKNOWN WHICH STENT GRAFT . AN INTERVENTION WAS CARRIED OUT A MONTH LATER WHERE A LEFT TO SUBCLAVIAN ARTERY BYPASS WAS PERFORMED IN ORDER TO TREAT THE TYPE IA ENDOLEAK AND THE ENDOLEAK WAS RESOLVED.  AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: High White Blood Cell Count; Insufficient Information

  MAUDE report 12867476 ↗
• DeathOct 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION, FROM THE LSA TO THE ABDOMINAL AORTA. IT WAS REPORTED 2 DAYS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY. IMAGING WAS PERFORMED AND IT SHOWING A KNOWN TYPE A AORTIC DISSECTION WITH STENT IN THE AORTIC ARCH. THE ORIGIN OF THE LEFT SUBCLAVIAN WAS NOT OPACIFIED WITH CONTRAST, HOWEVER THE VESSEL RECONSTITUTES AFTER THE ORIGIN OF THE LEFT VERTEBRAL ARTERY, RAISING THE POSSIBILITY OF THE LEFT SUBCLAVIAN STEAL. THE RIGHT BRACHIOCEPHALIC AND LEFT COMMON CAROTID ARTERIES WERE NOTED TO BE PATENT. ON THE DAY OF THE INDEX PROCEDURE THE PATIENT HAD A CT SCAN AND THERE WERE NO OBSERVATIONS. ONE DAY POST THE INDEX PROCEDURE THE PHYSICIAN SAW THE PATIENT AND REPORTED THE PATIENT WAS STABLE HOWEVER 2 HOURS LATER PATIENT HAD A STROKE AND SUBSEQUENTLY EXPIRED 3 DAYS POST THE INDEX PROCEDURE. AS PER THE PHYSICIAN THE CAUSE OF THE DEATH WAS A STROKE. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Stroke/CVA

  MAUDE report 12605545 ↗
• MalfunctionSep 16, 2021Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION THORACIC STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR AN ENDOVASCULAR TREATMENT APPROX. 1.5 YEARS POST IMPLANT IT WAS REPORTED THE PATIENT CONTACTED TECHNICAL SERVICES TO REPORT THAT THE STENT GRAFT WAS OBSERVED TO HAVE "SLIPPED OUT OF PLACE AND TURNED" DURING THEIR FOLLOW UP CT. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12481112 ↗
• MalfunctionApr 28, 2021Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC ULCER. IT WAS REPORTED A CT REVIEW OBSERVED TYPE IA, IB & IIIB ENDOLEAK WITH STENT RING ENLARGEMENT ON CT IMAGES FROM THE 8 MONTH FOLLOW UP. IT WAS REPORTED THE PHYSICIAN HAS BEEN NOTIFIED OF THE EVENT BUT THE PATIENT HAS BEEN LOST TO FOLLOW UP. ATTEMPTS HAVE BEEN MADE TO CONTACT THE PATIENT SINCE THE YEAR OF IMPLANT BUT THE PATIENT HAS OPTED TO HOLD OFF ON CT IMAGING. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11736244 ↗
• DeathSep 11, 2020Activation, Positioning or Separation Problem; Difficult to Advance; Activation, Positioning or Separation Problem; Difficult to Advance

  A VALIANT NAVION STENT GRAFT WAS ATTEMPTED TO BE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 300 MM THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN ATTEMPTED TO USE THE DEVICE OFF -LABEL IN ORDER TO ACHIEVE THE THORACIC ENDOVASCULAR AORTIC REPAIR IN THE PATIENT'S ZONE 0. IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY UNPACKED PART OF THE STENT GRAFT TO BURN A HOLE TO ALLOW PERFUSION TO THE INNOMINATE AND LEFT COMMON CAROTID. IT WAS REPORTED THAT DUE TO PATIENT'S ANATOMY, DIFFICULTY TO TRACK THE DEVICE TO ZONE 0 WAS ENCOUNTERED. ONCE THE DEVICE WAS IN THE INTENDED POSITION, DIFFICULTY SITTING THE DEVICE IN THE RIGHT ALIGNMENT WAS ENCOUNTERED. THE PHYSICIAN THEN PUT STENT GRAFT INTO SHEATH TO ADJUST BUT WAS UNABLE TO TRACK DOWN TO THE INTENDED POSITION. IT WAS STATED THAT AN ATTEMPT TO IMPLANT 2 NON-MEDTRONIC STENT GRAFTS WERE ALSO PERFORMED, WITH NO SUCCESS. A MEDTRONIC STENT GRAFT WAS THEN IMPLANTED TO FIX THE NON-MEDTRONIC STENT GRAFT DISTALLY. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS PATIENT'S ANATOMY. IT WAS STATED THAT THE PATIENT HAD A NARROW AORTIC ARCH. IT WAS REPORTED THAT THE PATIENT PASSES AWAY ON THE TABLE. T

  Patient problems: Death

  MAUDE report 10520299 ↗
• InjuryAug 2, 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 THORACIC AORTIC DISSECTION, FROM THE LSA TO THE ABDOMINAL AORTA. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, A 37/90 VALIANT NAVION STENT GRAFT WAS IMPLANTED AT THE LCC AND WAS THEN EXTENDED WITH A 43/37/200 VALIANT NAVION, WITH PERFECT OVERLAP. IT WAS REPORTED THAT THE PHYSICIANS WERE THEN CONCERNED THAT THE 37/90 VALIANT NAVION WAS ENCROACHING ON THE LCC, AND THEY DECIDED TO PLACE AN 8/29 BALLOON-EXPANDABLE BARE STENT FOR ACCESS. IT WAS REPORTED THAT ON THE DAY AFTER THE PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH AN RTAD. AN OPEN REPAIR WAS PERFORMED AS TREATMENT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Intimal Dissection; Occlusion

  MAUDE report 8854083 ↗