Valiant Navion™ VNMC4640C200TURecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000101275), received between May 7, 2020 and Oct 12, 2023 — classified as 4 deaths, 4 injuries, 1 malfunction.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• DeathOct 12, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A TYPE 2 THORACOABDOMINAL AORTIC ANEURYSM (ZONE 4-9) ON (B)(6) 2023. THE 46X40 TAPER GRAFT WAS PLACED JUST DISTAL TO LSCA, FOLLOWED BY ANOTHER 46X40. A THORACIC BIFURCATED GRAFT WAS THEN PLACED WITH A UNITARY MANIFOLD DEVICE IN THE UPPER ABDOMINAL AORTA; INDIVIDUAL STENTING OF CELIAC, SMA WITH NON MDT (ICAST) AND SELF-EXPANDING STENTS; INDIVIDUAL STENTING OF RENALS WITH NON MDT(VBX AND SELF-EXPANDING STENTS)  WAS COMPLETED DUE TO TORTUOSITY; AN EXTENSION DISTALLY WITH ENDURANT 16X16X124; 16X21X99 LIMBS INTO ILIACS. IT WAS REPORTED DURING THE INDEX PROCEDURE, COMPLETION ANGIOGRAM SHOWED A DELAYED TYPE IV ENDOLEAK. FOLLOW UP CT ON (B)(6) 2020 NOTED "THERE ARE NEW FOCI OF AIR THAT IS SEEN WITHIN THE NATIVE DISTAL THORACIC AORTA OUTSIDE THE ENDOGRAFT. THIS COULD BE RELATED TO RECENT MANIPULATION OF THE ENDOGRAFT. INFECTIOUS PROCESS IS ARE NOT EXCLUDED. IT WAS REPORTED THE PATIENT HAD A COMPLICATED POST-OP RECOVERY FOLLOWING THE INDEX PROCEDURE AND ULTIMATELY THE PATIENT WAS SENT TO INPATIENT REHAB BUT SUFFERED SEPSIS AND EXPIRED NEXT DAY ON (B)(6) 2020. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETER

  Patient problems: Embolism/Embolus; Sepsis

  MAUDE report 17919231 ↗
• DeathAug 14, 2023Leak/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 DURING THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. 2 VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED PREVIOUSLY.  IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING ON (B)(6)2018, (B)(6)2019, (B)(6)2020 AND (B)(6)2021. THE CT REVIEW OF IMAGES FROM (B)(6)2018 REVEALED A TYPE IA ENDOLEAK ON VNMF4646C183TU (B)(6).  IMAGES FROM (B)(6)2019 REVEALED TYPE IA ENDOLEAK AND AORTIC ENLARGEMENT OF +13.6MM WITH APPARENT AORTIC RUPTURE. THE FOLLOWING OBSERVATIONS WERE ALSO MADE; (B)(6)2019 REVEALED AORTIC ENLARGEMENT OF 11.4MM. (B)(6)2019 CT IMAGES REVEALED 12 MM AORTIC ENLARGEMENT. (B)(6)2019 IMAGING SHOWED AORTIC ENLARGEMENT 12 MM. (B)(6)2019 IMAGES REVEALED 13.3 MM AORTIC ENLARGEMENT. (B)(6)2019 REVEALED 14.8 MM AORTIC ENLARGEMENT (B)(6)2020 REVEALED STENT RING ENLARGEMENT (SRE) +1.5MM (NEW), RING 2; VNMF4646C183TU (B)(6) AND AORTIC ENLARGEMENT 17.6 MM. SRE IS IN THE FIRST SEALING STENT OF THE MOST PROXIMAL DEVICE (VNMF4646C183TU (B)(6)). (B)(6)2021 REVEALED TYPE IA ENDOLEAK (VNMF4646C183TU (B)(6), AND SRE 1.4MM ON RING 2 OF VNMF4646C183TU (B)(6)  AND AORTIC ENLARGEMENT OF 23.3MM, SRE IS IN THE FIRST SEALING STENT OF THE MOST PROXIMAL DEVICE (VNMF4646

  Patient problems: Insufficient Information; Rupture

  MAUDE report 17539410 ↗
• DeathJan 10, 2022Leak/Splash; Material Deformation; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Material Deformation; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC ANEURYSM OF AN UNKNOWN SIZE. TWO ADDITIONAL VALIANT NAVION GRAFTS WERE IMPLANTED ONE MONTH POST THE INDEX PROCEDURE. IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH SHORTNESS OF BREATH AND WAS ADMITTED DUE TO THORACIC ANEURYSM WITH WORSENING TYPE III ENDOLEAK OVERLAPPING THE ORIGINAL TEVAR GRAFT. AFTER VASCULAR & CARDIOTHORACIC SURGERY CONSULT IT WAS DECIDED THE PATIENT WAS A POOR SURGICAL CANDIDATE. THE PATIENT WAS DISCHARGED HOME UNDER HOSPICE CARE AND EXPIRED ON AN UNKNOWN DATE IN (B)(6) 2020. PER THE PHYSICIAN THE CAUSE OF THE TYPE IIIA ENDOLEAK IS UNDETERMINED. THE CAUSE OF DEATH WAS DUE TO THE ENDOLEAK AND IT WAS NOTED THAT THERE WAS NO TYPE I OR II ENOLEAKS AND THE SC WAS PATENT. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 13204937 ↗
• InjuryDec 17, 2021Leak/Splash; Leak/Splash

  2 X VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 220MM THORACIC AORTIC DISSECTION. ANOTHER VALIANT NAVION STENT GRAFT WAS IMPLANTED 6 DAYS PREVIOUSLY. IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE THE PATIENT RETURNED WITH CHEST PAIN, A CT SHOWED THAT THE NAVION STENT GRAFT HAD A TYPE III ENDOLEAK. IN ORDER TO RESOLVE THE ENDOLEAK THE PHYSICIAN REALIGNED THE VALIANT NAVION STENT GRAFTS WITH NON-MDT STENT GRAFTS (GORE) WHICH RESOLVED THE TYPE III ENDOLEAK. NO CAUSE OF THE TYPE III ENDOLEAK WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Chest Pain

  MAUDE report 13024870 ↗
• InjuryNov 15, 2021Fracture; Leak/Splash; Material Deformation; Fracture; Leak/Splash; Material Deformation

  VALIANT NAVION STENT GRAFT WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 60MM THORACIC AORTIC ANEURYSM . AN ADDITIONAL VALIANT NAVION STENT GRAFT WAS IMPLANTED APPROXIMATELY 7MONTHS LATER. A CT WAS PERFORMED APPROXIMATELY 24 MONTHS AFTER THE SECOND PROCEDURE . THE IMAGES WERE REVIEWED BY CORELAB WHERE A TYPE IIIB ENDOLEAK, 3 STENT FRACTURES AND STENT RING ENLARGEMENT OF +10.8MM WERE OBSERVED ON THE DISTAL DEVICE (VNMC4640C200TU, SN (B)(4)) .  NO CAUSE OF THE EVENT HAS BEEN PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12810745 ↗
• InjuryApr 23, 2021Leak/Splash; Leak/Splash

  VALIANT CAPTIVIA AND NAVION STENT GRAFTS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 67.8MM X 78.5MM THORACIC ANEURYSM. APPROX. 1 YEAR 8 MONTHS POST INDEX, AN ADDITIONAL 2 VALIANT NAVION DEVICES WERE IMPLANTED FOR AN UNKNOWN PROCEDURE IT WAS REPORTED THE CORE LAB OBSERVED THE FOLLOWING AFTER ANALYSIS OF THE 12M, INTERIM & 24M CTS: TYPE IIIB ENDOLEAK OF V07404460 VALIANT CAPTIVIA DEVICE & TYPE IIIA ENDOLEAK BETWEEN V08146953 AND V08097833 NAVION DEVICES. MOREOVER, 7 STENT FRACTURES (6 FRACTURES IN MOST DISTAL STENT AND 1 FRACTURE IN SECOND MOST DISTAL STENT) & STENT ENLARGEMENT IN SECOND STENT RING OF V08097833 NAVION DEVICE. NO CAUSE OF THE EVENT WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 11714948 ↗
• DeathApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 65MM AORTIC ANEURYSM WITH A 15MM THORACIC DISSECTION. APPROXIMATELY 2 MONTHS LATER, IT WAS REPORTED THE PATIENT HAD BEEN FOUND DEAD IN THEIR BATHROOM. PER THE PHYSICIAN THE CAUSE OF DEATH IS CURRENTLY UNKNOWN. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT HAS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 11712250 ↗
• MalfunctionMay 14, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 62MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THAT THE STENT GRAFT COMPLETELY DEPLOYED AS PER STANDARD TECHNIQUE AND THE GRAFT OPENED EXCEPT A SINGLE STENT (THIRD STENT OF THE GRAFT). IT WAS REPORTED THAT UPON BALLOONING THE STENT POPPED OPEN AS IF IT WASCONSTRAINED BY SOMETHING. IT WAS ALSO REPORTED THE STENT WAS POST DILATED WITH A 14MM STENT AND IT OPENED TO NOMINAL DIAMETER. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10055219 ↗
• InjuryMay 7, 2020Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 50MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT A CT PERFORMED ON AN UNKNOWN DATE REVEALED THAT THE PATIENT HAD A GUTTER ENDOLEAK FROM THE SNORKEL'S PLACED AT THE ORIGINAL IMPLANT OF THE GRAFTS. INTERVENTION WAS PERFORMED THREE MONTHS AFTER THE INDEX PROCEDURE WHERE THE PHYSICIAN EXTENDED THE ORIGINAL SNORKELS AND IMPLANTED A VNMC4646C95TU STENT GRAFT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS THE GUTTER LEAKS FROM THE SNORKELS AT THE TIME OF ORIGINAL IMPLANTATION. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 10032314 ↗