MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT NAVION; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Model Number	VNMC3434C182TU
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Disseminated Intravascular Coagulation (DIC) (1813); Fever (1858); Hemorrhage/Blood Loss/Bleeding (1888); Hemothorax (1896); Unspecified Infection (1930); Myocardial Infarction (1969); Pain (1994); Pneumonia (2011); Renal Failure (2041); Shock (2072); Vascular Dissection (3160); Aortic dissection (4870)
Date of Event	12/18/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
This is a system report.The section d information is for the primary device, which was in use with the following: brand name valiant navion; product id vnmc4646c95tu (serial: (b)(6)); product type: 0180-aortic stent graft; implant date (b)(6) 2020; brand name valiant navion; product id vnmc4040c95tu (serial: (b)(6)); product type: 0180-aortic stent graft; implant date (b)(6) 2020; brand name valiant navion; product id vnmc4646c95tu (serial: (b)(6)); product type: 0180-aortic stent graft; implant date: (b)(6) 2021.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
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 endoleak and a haemothorax.Treatment was given for ventilator-associated pneumonia.Despite supportive care, the patient¿s neurologic status remained poor, and following goals-of-care discussions, he was transitioned to comfort measures and expired one month post admission.The cause of the dissection and endoleak were not reported.
Additional Manufacturer Narrative
Additional information received: vnmc3434c182tu ((b)(6)) was confirmed as the most proximal navion graft.On the patients last follow up the endoleak was noted as a type ib and questionable type ii from the proximal thoracic component as well as enlarging of the infrarenal aortic aneurysm.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VALIANT NAVION
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24497306
• Report Number: 9612164-2026-01125
• Device Sequence Number: 10638736
• Product Code: MIH
• UDI-Device Identifier: 00763000260811
• UDI-Public: (01)00763000260811(17)220611
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2022
• Device Model Number: VNMC3434C182TU
• Device Catalogue Number: VNMC3434C182TU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/11/2026
• Date Device Manufactured: 06/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Outcome Attributed to Adverse Event: Death
• Patient Age: 59 YR
• Patient Sex: Male