MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV EVOLUT FX VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	EVOLUTFX-26
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Thickening of Material (4056)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Thrombosis/Thrombus (4440); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that approximately 2 years and 7 months following the implant of a transcatheter valve, the valve failed due to an unknown reason.A computed tomography (ct) scan was performed that revealed leaflet thickening with thrombus/pannus formation.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
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 that approximately 2 years and 7 months following the implant of a transcatheter valve, the valve failed due to an unknown reason.A computed tomography (ct) scan was performed that revealed leaflet thickening with thrombus/pannus formation.No patient complications were reported as a result of this event.Additional information was received that approximately two years and six months following the valve implant, examination and imaging showed the aortic valve well seated with no paravalvular leak (pvl)or issues noted.
Event or Problem Description
It was reported that approximately 2 years and 7 months following the implant of a transcatheter valve, the valve failed due to an unknown reason.A computed tomography (ct) scan was performed that revealed leaflet thickening with thrombus/pannus formation.No patient complications were reported as a result of this event.Additional information was received that approximately two years and six months following the valve implant, examination and imaging showed the aortic valve well seated with no paravalvular leak (pvl)or issues noted.Additional information was received that no treatment was prescribed for the transcatheter aortic valve as it was deemed not to have failed and the patient was not treated for thrombus.The patient is being evaluated for transcatheter mitral valve replacement due to severe mitral regurgitation.
Additional Manufacturer Narrative
Updated: b5, h6.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: EVOLUT FX VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23467486
• Report Number: 9617601-2025-02494
• Device Sequence Number: 8915591
• Product Code: NPT
• UDI-Device Identifier: 00763000370695
• UDI-Public: (01)00763000370695(17)240825
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 12/09/2025

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: 08/25/2024
• Device Model Number: EVOLUTFX-26
• Device Catalogue Number: EVOLUTFX-26
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 11/10/2025; 11/12/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 11/12/2025; 12/09/2025
• Date Device Manufactured: 08/26/2022
• 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: 82 YR
• Patient Sex: Female
• Patient Weight: 85 KG