Valiant NavionRecalls & reported problems across all models

We found 137 models of Valiant Navion by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 596 adverse event reports in the FDA's MAUDE database, received between Dec 4, 2018 and Jun 12, 2026 — classified as 140 deaths, 267 injuries, 189 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (355 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Valiant Navion recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 12, 2021Open, Classified

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

   Z-1201-2021 · Root cause: Under Investigation by firm · names 76 of these models · Recall details · FDA record ↗

Most reported Valiant Navion problems

Valiant Navion models

137 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.

• Valiant Navion™ VNMC3737C182TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall7 deaths26 reports
• Valiant Navion™ VNMC3434C182TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death23 reports
• Valiant Navion™ VNMF3731C173TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall3 deaths15 reports
• Valiant Navion™ VNMC3731C207TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death15 reports
• Valiant Navion™ VNMC4040C175TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall4 deaths14 reports
• Valiant Navion™ VNMF3737C174TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall2 deaths13 reports
• Valiant Navion™ VNMF3434C174TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall4 deaths10 reports
• Valiant Navion™ VNMC4343C175TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall3 deaths10 reports
• Valiant Navion™ VNMC4337C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death9 reports
• Valiant Navion™ VNMF3131C174TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall3 deaths8 reports
• Valiant Navion™ VNMC3131C182TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall3 deaths8 reports
• Valiant Navion™ VNMC4646C175TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall2 deaths8 reports
• Valiant Navion™ VNMC2828C182TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall2 deaths7 reports
• Valiant Navion™ VNMC3434C182TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death7 reports
• Valiant Navion™ VNMC4040C55TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall6 reports
• Valiant Navion™ VNMC3737C182TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall6 reports
• Valiant Navion™ VNMF3737C59TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall5 reports
• Valiant Navion™ VNMF4040C183TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death5 reports
• Valiant Navion™ VNMF4337C185TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall4 deaths5 reports
• Valiant Navion™ VNMC4040C175TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall5 reports
• Valiant Navion™ VNMF4040C62TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death4 reports
• Valiant Navion™ VNMF4646C183TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall2 deaths4 reports
• Valiant Navion™ VNMC2525C180TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death4 reports
• Valiant Navion™ VNMC4343C55TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall4 reports
• Valiant Navion™ VNMF4646C62TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall3 reports
• Valiant Navion™ VNMC3737C52TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death3 reports
• Valiant Navion™ VNMF3731C173TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death3 reports
• Valiant Navion™ VNMC4646C175TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall3 reports
• Valiant Navion™ VNMF2020C96TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall2 reports
• Valiant Navion™ VNMF2828C174TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death2 reports
• Valiant Navion™ VNMF4343C62TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death2 reports
• Valiant Navion™ VNMF4343C183TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death2 reports
• Valiant Navion™ VNMC3434C52TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall2 reports
• Valiant Navion™ VNMC4646C55TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall2 deaths2 reports
• Valiant Navion™ VNMC3125C207TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall2 reports
• Valiant Navion™ VNMF3125C173TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall2 reports
• Valiant Navion™ VNMC2828C182TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall2 reports
• Valiant Navion™ VNMC4343C55TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall2 deaths2 reports
• Valiant Navion™ VNMC3731C207TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall2 reports
• Valiant Navion™ VNMF2525C185TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death1 report
• Valiant Navion™ VNMF3125C173TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 report
• Valiant Navion™ VNMF2828C174TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 report
• Valiant Navion™ VNMF3131C174TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 report
• Valiant Navion™ VNMF3434C174TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 report
• Valiant Navion™ VNMF4040C183TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 death1 report
• Valiant Navion™ VNMF4343C183TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 report
• Valiant Navion™ VNMF4337C185TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 report
• Valiant Navion™ VNMC4337C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall1 report
• Valiant Navion™ VNMF2222C185TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMF3434C59TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMF2520C185TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMC2020C94TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMC2222C180TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMC2520C186TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMF2020C96TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMF2222C185TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMF2525C185TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMF3434C59TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMF3737C59TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMF3737C174TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMF4040C62TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMF4343C62TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMF4646C62TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMF4646C183TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMF2520C185TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMC2020C94TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMC2222C180TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMC2525C180TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMC3131C182TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMC3434C52TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMC3737C52TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMC4040C55TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMC4343C175TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMC4646C55TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMC2520C186TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMC3125C207TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 recall0 reports
• Valiant Navion™ VNMC3434C223TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  21 reports
• Valiant Navion™ VNMC3737C223TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 deaths18 reports
• Valiant Navion™ VNMF3737C229TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 deaths17 reports
• Valiant Navion™ VNMC3434C90TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths17 reports
• Valiant Navion™ VNMC3737C90TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  6 deaths14 reports
• Valiant Navion™ VNMC4034C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths14 reports
• Valiant Navion™ VNMF3737C97TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths13 reports
• Valiant Navion™ VNMC3131C90TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths12 reports
• Valiant Navion™ VNMC3428C207TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  12 reports
• Valiant Navion™ VNMC4040C95TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 deaths9 reports
• Valiant Navion™ VNMC4640C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths9 reports
• Valiant Navion™ VNMF3434C97TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths8 reports
• Valiant Navion™ VNMF3428C173TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death8 reports
• Valiant Navion™ VNMC4343C95TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths8 reports
• Valiant Navion™ VNMF4343C103TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 deaths7 reports
• Valiant Navion™ VNMC2828C90TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths7 reports
• Valiant Navion™ VNMC3737C90TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 deaths7 reports
• Valiant Navion™ VNMF4040C103TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  6 deaths6 reports
• Valiant Navion™ VNMF4040C223TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 deaths6 reports
• Valiant Navion™ VNMC4040C218TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death6 reports
• Valiant Navion™ VNMC4646C95TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths6 reports
• Valiant Navion™ VNMC4646C218TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death6 reports
• Valiant Navion™ VNMF2525C96TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death5 reports
• Valiant Navion™ VNMF3131C97TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death5 reports

Recent Valiant Navion adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Leak/Splash; Migration or Expulsion of Device

  IT WAS REPORTED THAT, DURING A FOLLOW-UP VISIT APPROXIMATELY 12.5 YEARS AFTER TREATMENT FOR AORTIC DISSECTION WITH TWO VALIANT NAVION STENT GRAFTS, COMPUTED TOMOGRAPHY REVEALED DISTAL MIGRATION OF THE PROXIMAL STENT GRAFT, WITH ANEURYSMAL DILATION OF THE THORACIC AORTA AT THE TRANSVERSE ARCH. THE PROXIMAL END OF THE STENT GRAFT DOES NOT ADEQUATELY APPOSE THE AORTIC WALL AND IS POSITIONED WITHIN THE THORACIC AORTIC ANEURYSM, RESULTING IN A TYPE IA ENDOLEAK. THE PROXIMAL DEVICE THAT HAS MIGRATED APPEARS TO BE THE VNMC3434C223TU. FUTURE INTERVENTION CONSISTING OF A RIGHT COMMON CAROTID ARTERY TO LEFT COMMON CAROTID ARTERY BYPASS, LIGATION OF THE LEFT COMMON CAROTID ARTERY, AND PROXIMAL EXTENSION OF THE EXISTING STENT GRAFT TO THE INNOMINATE ARTERY HAS BEEN PLANNED BUT NOT YET SCHEDULED. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm expansion

  MAUDE report 25483138 ↗
• InjuryApr 7, 2026Fracture; Leak/Splash

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 297MM THORACIC DISSECTION. IT WAS REPORTED ON AN UNKNOWN DATE, A POSSIBLE TYPE III ENDOLEAK IN THE DISTAL AREA OF THE GRAFT, STENT FRACTURE AND DISEASE PROGRESSION WERE IDENTIFIED. INTERVENTION WAS COMPLETED WHERE A NON MDT STENT WAS IMPLANTED HOWEVER THE ENDOLEAK REMAINED. PER THE PHYSICIAN THE CAUSE IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 24798634 ↗
• DeathMar 3, 2026Leak/Splash; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED FOR NSTMI AND FLANK PAIN AND WAS BEING TREATED BY CARDIO DUE TO HIS HEART FAILURE HISTORY. DURING ADMISSION A CT SHOWED CHRONIC AORTIC DISSECTION WITH ASCENDING ENDOLEAK. VASCULAR SURGERY WAS CONSULTED AND NO ACUTE INTERVENTION WAS RECOMMENDED WITH PLANS FOR ELECTIVE SURGERY IN 1 MONTH. DURING HOSPITALIZATION, THE PATIENT DEVELOPED ACUTE UNRESPONSIVENESS REQUIRING EMERGENT INTUBATION. THE PATIENT SUFFERED AN ACUTE INFARCT IN THE RIGHT OCCIPITAL LOBE AND A CHRONIC INFARCT IN THE LEFT PARIETAL LOBE AND WAS TREATED WITH THROMBOLYTIC THERAPY FOLLOWED BY SUCCESSFUL MECHANICAL THROMBECTOMY. THE POST-PROCEDURE COURSE WAS COMPLICATED BY EPISTAXIS AND OROPHARYNGEAL AND GROIN ACCESS BLEEDING, SUSPECTED TO BE THROMBOLYTIC-INDUCED DISSEMINATED INTRAVASCULAR COAGULATION. SIX HOUR POST THROMBECTOMY HEAD CT SHOWED R P-O EVOLVING INFARCT WITH HAEMORRHAGIC CONVERSION IN THE STROKE BED AND CONTRAST STAINING. DUE TO DIC PATIENT DEVELOPED A DISTRIBUTIVE SHOCK. THIS RESULTED IN ACUTE KIDNEY INJURY. THE PATIENT SUFFERED WITH PERSISTENT FEVERS AND LEUKOCYTOSIS, LIKELY RELATED TO WORSENING ASCENDING DISSECTION WITH EN

  Patient problems: Aortic dissection; Disseminated Intravascular Coagulation (DIC); Fever; Hemorrhage/Blood Loss/Bleeding; Hemothorax; Myocardial Infarction; Pain; Pneumonia; Renal Failure; Shock; Stroke/CVA; Unspecified Infection; Vascular Dissection

  MAUDE report 24497306 ↗
• InjuryJan 23, 2026Leak/Splash

  IT WAS REPORTED BY THE PATIENT, THROUGH PATIENT SERVICES, THAT A LEAK DEVELOPED IN A VALIANT NAVION STENT GRAFT IMPLANTED. THE LEAK OCCURRED APPROXIMATELY 3 YEARS POST IMPLANT AND WAS NOT COMMUNICATED TO THE PATIENT BY THE PHYSICIAN. THE PATIENT REPORTED DEVELOPING PARTIAL VOCAL CORD PARALYSIS AS A RESULT OF THE LEAK.

  Patient problems: Paralysis

  MAUDE report 24158963 ↗
• MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE . IT WAS REPORTED THAT CORELAB REVIEWED CTS DATED OVER FIVE YEAR LATER AND IDENTIFIED STENT RING ENLARGEMENT OF +2.9MM ON RING 5 OF THE STENT GRAFT. THE MAXIMUM AORTIC DIAMETER IS 50.4MM. NO ENDOLEAK, FRACTURE OR STENT RING DISPLACEMENT WAS OBSERVED. NO CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300474 ↗
• MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A DISSECTION. CORELAB REVIEWED CT IMAGING WHICH WAS TAKEN 6.5 YEARS LATER. NO ENDOLEAK, FRACTURE OR STENT RING MIGRATION WERE NOTED. A NEW STENT RING ENLARGEMENT OF + 1.4MM WAS OBSERVED ON RING 5 OF (B)(6). THE MAXIMUM AORTIC DIAMETER MEASURED 63MM. NO AORTIC ENLARGEMENT WAS OBSERVED. NOADDITIONAL CLINICAL SEQUALAE WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23276673 ↗
• DeathSep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZED TAA AND DISSECTION. IT WAS REPORTED THAT CORELAB HAVE REVIEWED CT IMAGING AND HAVE IDENTIFIED A TYPE IA ENDOLEAK ON THE STENT GRAFT WITH SN (B)(6). NO FRACTURE, STENT RING ENLARGEMENT/MIGRATION WERE NOTED. THE MAXIMUM AORTIC DIAMETER WAS 54.6MM. IT WAS REPORTED THE PATIENT PRESENTED WITH A CONTAINED RUPTURE OF TYPE A AORTIC DISSECTION APPROXIMATELY 4 YEARS AND 8 MONTHS AFTER THE INDEX PROCEDURE. THE PATIENT UNDERWENT SURGERY BUT SUFFERED A PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST IN THE INTENSE CARE UNIT (ICU). FOLLOWING THE ARREST, COMFORT CARE WAS INITIATED AT THE FAMILY'S REQUEST. THE PATIENT EXPIRED ON THE SAME DATE. THE CAUSE OF DEATH WAS ASSESSED AS AORTIC-RELATED DUE TO THE DISSECTION. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 23081689 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DISTAL STENT RING OF THE 37MM NAVION STENT GRAFT BECAME DISCONNECTED FROM THE FABRIC DURING TREATMENT FOR AORTIC DISSECTION. THE NAVION PRODUCT WAS IDENTIFIED AS PART OF THE SAFE-N-RECALL. THE EVENT WAS DISCOVERED THROUGH COMPUTED TOMOGRAPHY APPROXIMATELY 5 YEARS AND 2 MONTHS POST-INDEX PROCEDURE , WHICH REVEALED THAT THE DISTAL STENT RING HAD AN AVERAGE DIAMETER OF 39.2MM X 44.8MM, INDICATING DISCONNECTION FROM THE FABRIC. THERE WAS NO CALCIFICATION NOTED AT THE DISTAL LANDING ZONE, HOWEVER THE DISTAL STENT IS LOCATED IN A DEGENERATED AREA OF THE DESCENDING THORACIC AORTA. NO ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN IS CONCERNED THAT THE STENT RING WOULD MIGRATE PROXIMALLY WHICH COULD CAUSE AN ENDOLEAK. THE REMAINING SEGMENT OF THE DESCENDING THORACIC AORTA HAS REMODELED. ADDITIONALLY, THE AORTIC DIAMETER AT THE PROXIMAL EDGE OF THE VALIANT NAVION (VNMC3434C223TU) NOW AVERAGES 37.8MM, AND AT THE LEFT SUBCLAVIAN ARTERY (LSA), IT AVERAGES 36.2MM. IT WAS CONFIRMED THAT THE PROXIMAL STENT RING IS COMPLETELY INTACT. THERE IS MILD AORTIC DEGENERATION AT THE PROXIMAL EDGE OF THIS STENT, WHERE THE FIRST STENT RING OF THE 34 MM DEVICE HAD LANDED AS THE AORTA HAS GROW

  Patient problems: Aneurysm; Insufficient Information

  MAUDE report 22911023 ↗
• MalfunctionJul 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  TWO VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A DISSECTION ON (B)(6) 2020. IT WAS REPORTED VIA CORE LAB REVIEW OF FILMS APPROXIMATELY 4 YEARS AND 3 MONTHS POST IMPLANT THAT STENT RING ENLARGEMENT WAS IDENTIFIED IN (B)(6). NO CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677311 ↗
• MalfunctionJul 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A DISSECTION. IT WAS REPORTED THAT CORELAB REVIEWED CT IMAGING DATED AND IDENTIFIED NEW STENT RING ENLARGEMENT OF +2.6MM ON RING 4, +1.5MM ON RING 2 AND +1.2MM ON RING 3 OF (B)(6). THE MAXIMUM AORTIC DIAMETER IS NOTED AS 44.1MM. NO ENDOLEAKS, FRACTURE OR STENT RING MIGRATION WAS OBSERVED. NO CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628867 ↗
• MalfunctionJul 16, 2025Leak/Splash; Leak/Splash

  CORELAB REVIEW OF CTS TAKEN APPROXIMATELY 2 YEARS AND 2 MONTHS POST-INDEX PROCEDURE IDENTIFIED A NEW TYPE IB ENDOLEAK INVOLVING THE DEVICE VNMF4640C185TU (SN (B)(6)) . THE MAXIMUM AORTIC DIAMETER MEASURED 78MM. NO AORTIC ENLARGEMENT, STENT RING ENLARGEMENT OR STENT RING MIGRATION WAS OBSERVED. THE IMAGE WAS NO EVALUABLE FOR FRACTURE DUE TO DEVICE OVERLAPS. CORELAB REVIEW OF CTS TAKEN 10 MONTHS LATER CONFIRMED A PERSISTENT TYPE IB ENDOLEAK IN THE SAME VALIANT NAVION STENT GRAFT. THE MAXIMUM AORTIC DIAMETER MEASURED 80MM. NO AORTIC ENLARGEMENT, STENT RING ENLARGEMENT OR STENT RING MIGRATION WAS OBSERVED. IT WAS NOTED THAT FRACTURE EVALUATION WAS DIFFICULT DUE TO MULTIPLE DEVICE OVERLAPS. THE CAUSE OF THE TYPE IB ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22517651 ↗
• InjuryJun 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  TWO VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED APPROX. 5 YEARS, 11 MONTHS POST INDEX PROCEDURE, A SECONDARY PROCEDURE WAS PERFORMED. THIS INVOLVED DEBRANCHING OF THE LEFT SUBCLAVIAN AND VERTEBRAL ARTERY WITH TRANSPOSITION. THE PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF 500CC BUT REMAINED STABLE AND DID NOT REQUIRE TRANSFUSION. GOOD FLOW WAS ACHIEVED IN THE SUBCLAVIAN, CAROTID AND LEFT VERTEBRAL ARTERIES FOLLOWING THE TRANSPOSITION. TWO DAYS LATER, A FOLLOW UP PROCEDURE WAS CONDUCTED ADDRESS PROXIMAL DEGENERATION / GRAFT MIGRATION WHICH HAD RESULTED IN A TYPE IA ENDOLEAK. A PROXIMAL EXTENSION WAS PLACED AS PART OF AN ENDOVASCULAR AORTIC REPAIR. ADDITIONAL DISTAL COMPONENTS WERE PLACED TO TREAT EXPANDING PARA VISCERAL AND DISTAL DESCENDING OF TAA, WHICH DEVELOPED ABOVE THE PREVIOUSLY PLACED ABDOMINAL FENESTRATED GRAFT. THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS NOTED TO BE DIFFUSELY DISEASED WITH TWO REGIONS OF SEVERE STENOSIS. DURING THIS PROCEDURE, THREE NON-MEDTRONIC GRAFTS WERE SUCCESSFULLY IMPLANTED IN THE THORACIC AORTA, ACHIEVING EXCELLENT FLOW THROUGH THE GRAFTS AND EFFECTIVE COVERAGE OF THE DISEASED AORTA. THE PROXI

  Patient problems: Aneurysm expansion; Insufficient Information

  MAUDE report 22227166 ↗
• InjuryJun 17, 2025Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  TWO VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED APPROX. 5 YEARS, 11 MONTHS POST INDEX PROCEDURE, A SECONDARY PROCEDURE WAS PERFORMED. THIS INVOLVED DEBRANCHING OF THE LEFT SUBCLAVIAN AND VERTEBRAL ARTERY WITH TRANSPOSITION. THE PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF 500CC BUT REMAINED STABLE AND DID NOT REQUIRE TRANSFUSION. GOOD FLOW WAS ACHIEVED IN THE SUBCLAVIAN, CAROTID AND LEFT VERTEBRAL ARTERIES FOLLOWING THE TRANSPOSITION. TWO DAYS LATER, A FOLLOW UP PROCEDURE WAS CONDUCTED ADDRESS PROXIMAL DEGENERATION / GRAFT MIGRATION WHICH HAD RESULTED IN A TYPE IA ENDOLEAK. A PROXIMAL EXTENSION WAS PLACED AS PART OF AN ENDOVASCULAR AORTIC REPAIR. ADDITIONAL DISTAL COMPONENTS WERE PLACED TO TREAT EXPANDING PARA VISCERAL AND DISTAL DESCENDING OF TAA, WHICH DEVELOPED ABOVE THE PREVIOUSLY PLACED ABDOMINAL FENESTRATED GRAFT. THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS NOTED TO BE DIFFUSELY DISEASED WITH TWO REGIONS OF SEVERE STENOSIS. DURING THIS PROCEDURE, THREE NON-MEDTRONIC GRAFTS WERE SUCCESSFULLY IMPLANTED IN THE THORACIC AORTA, ACHIEVING EXCELLENT FLOW THROUGH THE GRAFTS AND EFFECTIVE COVERAGE OF THE DISEASED AORTA. THE PRO

  Patient problems: Aneurysm expansion; Insufficient Information

  MAUDE report 22227031 ↗
• InjuryMay 2, 2025Fracture; Leak/Splash; Adverse Event Without Identified Device or Use Problem; Fracture; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 59MM TAAA. THE 43X43X100 WAS IMPLANTED PROXIMALLY, 46X46X183 DISTALLY, BRIDGED WITH 46X46X183 STENT GRAFT. THE PATIENT WAS LOST TO FOLLOW-UP AND LATER PRESENTED TO A DIFFERENT FACILITY FOR AN UNRELATED INCIDENT AND A CT SCAN WAS PERFORMED . ON THE CT SCAN, THE TWO PHYSICIANS REVIEWING INITIALLY THOUGHT THAT THE DISTAL AND MIDDLE NAVION DEVICES HAD PULLED UP FROM THEIR INITIAL LANDING ZONES DUE TO ANEURYSM ENLARGEMENT BUT A STENT FRACTURE WAS ALSO SUGGESTED AS POSSIBLE CAUSE OF THE ISSUE. A PLAN WAS MADE TO RELINE THE DEVICE DOWN TO THE SMA AS THE CELIAC ARTERY WAS COMPLETELY STENOSED WITHOUT ANTEGRADE FLOW, THE STENOSIS WAS UNRELATED TO THE NAVION STENT GRAFTS. NO ISSUES WERE NOTED WITH THE OTHER STENT GRAFTS. DURING THE INTERVENTION PROCEDURE, A FRACTURE PIECE OF THE STENT COULD BE VISUALIZED WELL BELOW THE REMAINING FABRIC AND STENT BODY OF THE MOST DISTAL NAVION DEVICE. THE PHYSICIAN THEN SUSPECTED THAT THE DISTAL NAVION FRACTURED LEAVING BEHIND A PARTIAL STRUT IN THE INITIAL DISTAL LANDING ZONE, WITH ITS FABRIC AND REMAINING STRUTS PULLED UP TOWARDS THE AORTIC ARCH. THE VALIANT NAVION LOST DISTAL SEAL

  Patient problems: Insufficient Information

  MAUDE report 21949430 ↗
• InjuryApr 24, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE VALIANT NAVION DISTAL STENT GRAFT SEPARATED FROM THE PROXIMAL VALIANT NAVION STENT, AND A TYPE III ENDOLEAK WAS PRESENT IN THE THORACIC AORTA. THE EVENT WAS DISCOVERED ON THE DATE OF COMPUTED TOMOGRAPHY. THE PATIENT WAS INITIALLY TREATED FOR A DISSECTION MEASURING 200MM IN LENGTH. TREATMENT INVOLVED RE-LINING THE EXISTING GRAFTS WITH A 38-34/150 VALIANT CAPTIVIA PROXIMAL GRAFT AND A 38-34/150 VALIANT CAPTIVIA DISTAL GRAFT. THE HEALTHCARE PROFESSIONAL ATTRIBUTED THE CAUSE OF THE EVENT TO ANATOMICAL CHANGES AS THE THORACIC AORTA BULGED OUT ON THE OUTER CURVE, CAUSING THE DISTAL GRAFT TO SLIDE DOWN AND SEPARATE FROM THE PROXIMAL GRAFT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21900289 ↗

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