Valiant Navion™ VNMC4646C95TURecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000101176), received between Oct 1, 2021 and Mar 20, 2024 — classified as 2 deaths, 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• DeathMar 20, 2024Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS (VNMC4646C95TU) WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM ON (B)(6) 2019. THE PATIENT HAD 2 EXISTING TALENT THORACIC STENT GRAFTS IMPLANTED APPROXIMATELY 8 YEARS PREVIOUSLY. IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING FOR THE NAVION DEVICES TAKEN ON (B)(6) 2021 SHOWED A NEW UNDETERMINED ENDOLEAK. THE MAX AORTIC DIAMETER WAS NOTED AS 116MM. THE IMAGING WAS NA FOR AORTIC ENLARGEMENT. NO STENT RING ENLARGEMENT OR STENT RING MIGRATION WAS OBSERVED. THE IMAGING WAS NON EVALUABLE FOR STENT FRACTURES DUE TO ARTIFACT. IT WAS REPORTED THE PATIENT EXPIRED ON AN UNKNOWN DATE. THE CAUSE OF THE ENDOLEAK AND DEATH IS UNDETERMINED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18941096 ↗
• MalfunctionJan 13, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFT WERE IMPLANTED DURING THE TREATMENT OF AN UNKNWON SIZE ANEURYSM. IT WAS REPORTED ON THE ONE MONTH FOLLOW UP CT IMAGING, A TYPE IB ENDOLEAK WAS NOTED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16155860 ↗
• InjuryNov 11, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION (V08147847) STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TYPE IA ENDOLEAK AS A ENDOGRAFT EXTENSION WITH BILATERAL RENAL ARTERY AND SMA SNORKELING. A ENDURANT II STENT GRAFT SYSTEM HAD BEEN IMPLANTED 3 YEARS AND 5 MONTHS PREVIOUSLY. ABOUT 5 MONTHS POST THE NAVION IMPLANT, THE PATIENT WAS STRUGGLING WITH VARIOUS ENDOLEAKS AND COIL EMBOLIZATION AND GLUE WAS USED AS TREATMENT. 4 MONTHS LATER, AN AORTIC ENDOLEAK REQUIRED INTERVENTION WITH ONYX GLUE. ANOTHER 8 MONTHS LATER, THE PATIENT HAS A TAAA THAT IS AT AN OPERABLE SIZE. THE PATIENT UNDERWENT AN OPEN REPAIR, A NON MDT BRANCH GRAFT WAS PLACED WHILE THE VALIANT NAVION V08147847 WAS EXPLANTED. ANOTHER 6 MONTHS LATER, A NEW THORACIC AORTIC ANEURYSM AND THORACOABDOMINAL AORTIC DISSECTION WERE OBSERVED SO 6 VALIANT NAVIONS WERE IMPLANTED. A CT SCAN WAS PERFORMED JUST OVER 3 MONTHS POST THE 6 VALIANT NAVION IMPLANTS. A CT OF THE CHEST DEMONSTRATES THE DIMENSIONS OF THE THORACIC AORTIC ANEURYSM IN THE APPEARANCE OF THE ENDOGRAFT REPAIR ARE STABLE. THE NATIVE ANEURYSM MEASURES UP TO 6.3 CM AXIALLY IN THE DESCENDING AORTA. THE DENSITY OF THE CLOT IN THE ANEURYSM OF THE DESCENDING THORACIC AORTA IS DIMINISHED FR

  Patient problems: Insufficient Information; Pleural Effusion

  MAUDE report 15779888 ↗
• InjurySep 13, 2022Malposition of Device; Malposition of Device

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A RUPTURED THORACOABDOMINAL AORTIC ANEURYSM . ABOUT 7 YEARS LATER, FOLLOW CT IDENTIFIED GROWTH (3MM IN 6 MONTHS) AT THE DISTAL ENDO OF THE STENT GRAFT IN THE DISTAL DESCENDING THORACIC AORTA. INTERVENTION WAS COMPLETED. DURING THE PROCEDURE THE VALIANT NAVION GRAFT 46X46X95, SN (B)(4) WAS ADVANCED AND DEPLOYED IN THE THORACIC AORTA WITH GOOD OVERLAP WITH THE PREVIOUSLY PLACED ENDOGRAFT. DUE TO THE TORTUOSITY OF THE AORTA, AS THE GRAFT MOLDED TO THE AORTA, THE DISTAL END DID MOVE MORE PROXIMALLY ALONG THE AORTA THAN ANTICIPATED, THUS AN ADDITIONAL NAVION 46X46X95, WAS DEPLOYED WITH ADEQUATE OVERLAP WITH THE FIRST PLACED GRAFT. AGAIN, DUE TO TORTUOSITY, THE GRAFT DID END MORE PROXIMAL TO THE CELIAC ARTERY THAN WAS DESIRED AND THE LATERAL ASPECT OF THE DISTAL MOST PART OF THE GRAFT DOES NOT HAVE COMPLETELY WALL APPOSITION. HOWEVER, SEAL WAS OBTAINED FOR THE AREA ABOVE WHERE THE DILATION WAS PRESENT AND THERE WERE NOT ENDOLEAKS OBSERVED. A CT WAS WAS PERFORMED LAST YEAR , WHERE AN CONTINUED GROWTH AND AORTIC ENLARGEMENT WAS OBSERVED. A SECOND PROCEDURE WAS PERFORMED TO TREAT THE EVENT HOWEVER WHEN ATTEMPT

  Patient problems: Aneurysm

  MAUDE report 15409033 ↗
• DeathDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN UNKNOWN THORACIC ENDOVASCULAR PROCEDURE . IT WAS REPORTED THAT THE PATIENT EXPIRED 17 DAYS LATER DUE TO CARDIAC ARREST. NO CAUSE OF THE CARDIAC ARREST WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Cardiac Arrest

  MAUDE report 12932614 ↗
• MalfunctionOct 1, 2021Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE PATIENT FOR AN ENDOVASCULAR TREATMENT. APPROXIMATELY 23 MONTHS POST IMPLANT IT WAS REPORTED THE CORELAB OBSERVED A TYPE IB ENDOLEAK FROM CTS TAKEN ON (B)(6) 2020 IT WAS REPORTED THAT AS THE 2 VALIANT NAVIONS IMPLANTED ARE THE SAME SIZE, IT IS UNKNOWN WHICH STENT GRAFT WAS IMPLANTED DISTALLY AND CONTAINS THE IB ENDOLEAK, FROM THE CT IMAGING THAT WAS PERFORMED. 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 12561628 ↗