Valiant Navion™ VNMF3737C59TU (UDI 00763000100667)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000100667), received between Feb 26, 2019 and Jul 20, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 12, 2021Class IOpen, Classified

   Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.

   Z-1201-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2023Leak/Splash; Leak/Splash

  TWO VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING  AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED VIA CORELAB REVIEW OF CT IMAGES DATED (B)(6) 2020, (B)(6) 2020, (B)(6) 2021, (B)(6) 2021 AND (B)(6) 2022 THAT A TYPE IA ENDOLEAK WAS OBSERVED IN VNMF3737C59TU ((B)(6)). IT WAS NOTED THAT THE TYPE IA ENDOLEAK WAS NEW ON (B)(6) 2020 AND PERSISTENT ON (B)(6) 2020, (B)(6) 2021, (B)(6) 2021 AND (B)(6) 2022. THERE WAS NO STENT RING ENLARGEMENT OBSERVED. FRACTURE AND STENT RING MIGRATION WERE NON-EVALUABLE DUE TO DEVICE OVERLAPS AND CALCIUM PRESENCE. THE MAXIMUM AORTIC DIAMETER WAS 219MM ON (B)(6) 2020, 223MM ON (B)(6) 2020, 244MM ON (B)(6) 2021, 147MM ON (B)(6) 2021 AND 163MM ON (B)(6) 2022. THERE WAS AORTIC ENLARGEMENT OF +25MM NOTICED ON CT TAKEN ON (B)(6) 2021 COMPARED TO THE CT FROM (B)(6) 2020. THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 17359766 ↗
• InjuryDec 6, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AORTIC ANEURYSM. IT WAS REPORTED ON AN UNKNOWN DATE, FOLLOW UP IMAGING IDENTIFIED AN EXPANDING ABDOMINAL AORTIC ANEURYSM WITH SUSPECTED OCCULT TYPE III ENDOLEAK AND IMPENDING LOSS OF SEAL IN THE RIGHT ILIAC LIMB. APPROXIMATELY 12 MONTHS POST INDEX PROCEDURE ULTRASOUND GUIDED NEEDLE PLACEMENT RIGHT FEMORAL ARTERY, CIRCUMFERENTIAL PLACEMENT OF ENDOANCHORS IN THE ABDOMINAL AORTIC ENDOGRAFT AND PLACEMENT OF A RIGHT ILIAC LIMB EXTENSION WAS COMPLETED. IT WAS REPORTED APPROXIMATELY 12 MONTHS LATER THE PATIENT PRESENTED AND WAS DIAGNOSED WITH A R MCA INFARCT AND HOSPITALIZED. TREATMENT WAS GIVEN AND THE PATIENT HAD A HAEMORRHAGIC CONVERSION WITH ICH, IV EXTENSION AND SAH. THE PATIENT WAS INTUBATED BUT EXTUBATED FOR COMFORT CARE AND THE PATIENT EXPIRED 2 DAYS POST HOSPITALISATION. PER THE PHYSICIAN THE CAUSE OF THE ANEURYSM EXPANSION AND TYPE III ENDOLEAK ARE UNDETERMINED. THE CAUSE OF THE STROKE LEADING TO DEATH WAS NOT PROVIDED.

  Patient problems: Insufficient Information; Stroke/CVA

  MAUDE report 15922316 ↗
• InjuryNov 18, 2022Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA.  IT WAS REPORTED A CTA PERFORMED 4 DAYS LATER, A POSSIBLE TYPE IA ENDOLEAK WAS NOTED.  THE PATIENT RETURNED FOR INTERVENTION JUST UNDER 2 YEARS LATER. IT WAS NOTED THE MOST PROXIMAL AORTIC STENT BEGINS AT THE ZONE 3 ZONE 4 JUNCTION AND DISTALLY THE PATIENTS ENDOVASCULAR STENTING TERMINATES IN THE EXTERNAL ILIAC ARTERIES BILATERALLY. BOTH  INTERNAL ILIAC ARTERIES HAD BEEN SACRIFICED. THE PATIENT HAS A SOLITARY RIGHT KIDNEY AND THE PARA VISCERAL AORTA HAS BEEN TREATED WITH STENTING WITH A CHIMNEY GRAFT TO THE RIGHT RENAL ARTERY AND PERISCOPE GRAFT TO THE CELIAC ARTERY AND SUPERIOR MESENTERIC ARTERY. IT HAS BEEN NOTED OVER THE LAST 12-24 MONTHS THAT THE AORTA IN ZONE 3 HAS BEEN PROGRESSIVELY DILATING AND WITH THAT THE PATIENTS ENDOGRAFT MIGRATED FROM PROXIMAL ZONE 3 INTO THE ZONE 3 ZONE FOR JUNCTION. THE PATIENT HAS NOW HAS A 6 CM ZONE 3 THORACIC AORTIC ANEURYSM AND A LARGE ENDOLEAK/ANEURYSM AT THE PROXIMAL LANDING ZONE.  THE PATIENT UNDERWENT A ASCENDING AORTIC REPAIR. THE PATIENT HAD DEBRANCHING OF MAJOR VESSELS AND GRAFTING TO THE DESCENDING AORTA WITH SUBSEQUENT REPAIR OF THE REMAINDER OF ASCENDING

  Patient problems: Insufficient Information

  MAUDE report 15823555 ↗
• InjuryNov 18, 2022Leak/Splash; Leak/Splash

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. A VALIANT NAVION STENT GRAFT WAS IMPLANTED DUE TO CONTINUED DILATION OF THE AORTIC ANEURYSM 8 YEARS POST THE INDEX PROCEDURE IT WAS REPORTED APPROXIMATELY 8 MONTHS POST THE NAVION PROCEDURE, FOLLOW UP CT DEMONSTRATED A STABLE SMALL ENDOLEAK ADJACENT TO THE DISTAL ASPECT OF THE STENT GRAFT ANTERIORLY WITHIN THE PROXIMAL DESCENDING THORACIC AORTA. CT IMAGING 2 YEARS POST THE NAVION IMPLANT PROCEDURE SHOWED AN INCREASED DENSITY EXTENDING FROM THE ANTERIOR PROXIMAL MARGIN OF THE STENT WITH EXTENSION INTO THE INFERIOR ASPECT OF THE EXCLUDED ANEURYSM SAC CONSISTENT WITH A TYPE I ENDOLEAK. ON (B)(6) 2022 INTERVENTION WAS COMPLETED. NON MDT STENTS WERE IMPLANTED TO RESOLVE THE ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 15822460 ↗
• InjuryFeb 26, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 64MM AN INFRA-RENAL ANEURYSM IN CONJUNCTION WITH A NON MDT DEVICE. IT WAS NOTED THE PATIENT HAD SEVERELY DISEASED BILATERAL ILIACS THROUGHOUT. IT WAS REPORTED DURING THE INDEX PROCEDURE THE RIGHT ILIAC WAS PRE-DILATED WITH NON MDT 7 AND 8 MM BALLOONS. AFTER DEPLOYMENT OF THE NON MDT DEVICE THE PHYSICIAN ATTEMPTED TO ADVANCE THE NAVION DEVICE (B)(4). THE DEVICE WOULD NOT TRACK UP SO THE ILIAC WAS DILATED AGAIN WITH AN 8MM BALLOON AND ALTHOUGH A TIGHT FIT THE DEVICE DID TRACK. AFTER DEPLOYMENT OF THE GRAFT BUT BEFORE THE RELEASE OF THE TIP CAPTURE THE PHYSICIAN FELT A POP AND AT THIS POINT A RAPID DECREASE IN THE PATIENT'S BLOOD PRESSURE WAS NOTED. THE PROXIMAL BARE SPRINGS WERE DEPLOYED HOWEVER UPON REMOVAL OF THE DELIVERY SYSTEM SOME OF THE PATIENT'S BLOOD VESSEL WERE OBSERVED TO BE ATTACHED TO THE DELIVERY SYSTEM. AN INTRA-OPERATIVE ARTERIOGRAM WAS PERFORMED AND A RUPTURE AT THE PATIENT'S RIGHT EXTERNAL ILIAC WAS OBSERVED. MULTIPLE COVERED STENTS WERE USED IN AN ATTEMPT TO REPAIR THE ARTERY UNSUCCESSFULLY AND THE PHYSICIAN ELECTED TO CONVERT TO AN OPEN REPAIR OF THE RIGHT ILIAC. LIGATION OF THE N

  Patient problems: Low Blood Pressure/ Hypotension; Rupture; Thrombus

  MAUDE report 8369985 ↗