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

Catalog Number	VNMC3434C223TU
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	05/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
Product analysis conclusion: the reported migration and type ia endoleak were confirmed on the reviewed images; however, the cause of the event cannot be conclusively determined based on the limited images provided.Pre-implant ct imaging was not available for assessment of the baseline anatomy, and earlier post-implant cts were not available for comparison of the stent graft in vivo configuration over time.Given the long interval (approximately 12.5 years) since the index procedure, it is possible that progression of aortic disease with changes in aneurysm morphology may have altered the proximal landing zone over time, potentially contributing to loss of proximal seal and the observed migration and proximal endoleak.Analysis of the reviewed images did not reveal any obvious stent graft integrity issues.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: 25483138
• Report Number: 9612164-2026-03037
• Device Sequence Number: 9966148
• Product Code: MIH
• UDI-Device Identifier: 00763000101039
• UDI-Public: (01)00763000101039(17)210818
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Report Date (Section B): 06/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/18/2021
• Device Catalogue Number: VNMC3434C223TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2019
• 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
• Patient Age: 72 YR
• Patient Sex: Male