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

Model Number	VNMC3737C90TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Insufficient Information (4580); High White Blood Cell Count (4594)
Date of Event	03/12/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Other relevant device(s) are: product id: vnmc3737c182tu, serial/lot #: (b)(4), ubd: 26-may-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Valiant navion stent grafts were implanted during an endovascular procedure for the treatment of a thoracic aortic aneurysm of an unknown size.A left subclavian transposition, subsequent to the deployment of valiant navion was also performed.It was reported during a follow-up ct about 18 months later that a type ia endoleak was noted on one of the grafts.It is unknown which stent graft.An intervention was carried out a month later where a left to subclavian artery bypass was performed in order to treat the type ia endoleak and the endoleak was resolved.  as per the physician the cause of the type ia endoleak could not be determined.  no additional clinical sequalae was provided and the patient is fine.
Additional Manufacturer Narrative
Core lab review of ct imaging from approximately 18 months post index procedure observed no endoleak, fracture, stent ring enlargement or stent ring migration.Core lab review of ct imaging from approximately 27 months post index procedure observed no endoleak, stent ring enlargement or stent ring migration.The imaging was non evaluable for fracture.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.
Additional Manufacturer Narrative
B5; additional information received: it was reported the patient expired approximately 2 years and 11 months after the index procedure.The cause of death was noted as aortic related.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.
Additional Manufacturer Narrative
Correction to b5.The previously reported sentence "the cause of death was noted as aortic related" should read " the cause of death was noted as aortic related due to a type i endoleak." 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.
Additional Manufacturer Narrative
Additional information received: it was clarified that the endoleak involved in the patient's death was a type ia.The site reported that the initial evaluation included a cta of the chest, which showed a type 1 endoleak at the site of a previous aortic graft.This endoleak had increased compared to prior imaging.The original plan was to take the patient to the or after starting broad-spectrum antibiotics the day before due to possible aortopulmonary fistula, as recommended by vascular surgery.The patient's white blood cell count (wbc) was rising, from 20.5 on 11-aug to 30.0.Because the wbc count continued to increase, there was concern for infection of the aortic graft, so surgery was canceled.The plan then changed to discharge the patient to hospice care at home on the following day.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 TREATMENT
• 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: 12867476
• Report Number: 9612164-2021-04539
• Device Sequence Number: 3708275
• Product Code: MIH
• UDI-Device Identifier: 00763000101053
• UDI-Public: (01)00763000101053(17)210522
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/15/2025

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: 05/22/2021
• Device Model Number: VNMC3737C90TU
• Device Catalogue Number: VNMC3737C90TU
• 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: 11/17/2021
• Supplement Date Received by Manufacturer: 05/28/2024; 09/08/2025; 09/11/2025; 10/07/2025
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 06/26/2024; 09/11/2025; 09/11/2025; 10/15/2025
• Date Device Manufactured: 05/23/2019
• 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 H10...."
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female