MAUDE Adverse Event Report: Medtronic Mexico S. De R.L. De CV EVOLUT FX VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	EVOLUTFX-23
Medical Device Problem Codes	Gradient Increase (1270); Patient Device Interaction Problem (4001); Thickening of Material (4056); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Transvalvular Pressure Gradient Increased (4854)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 1 year and 2 months following the implant of a transcatheter aortic valve, an echocardiogram was performed revealing moderate aortic stenosis and a mean gradient of 30 millimeters of mercury (mmhg).Approximately 4 days later, the patient reported increased shortness of breath.Approximately 4 months later, a computed tomography (ct) scan was performed, demonstrating hypoattenuated leaflet thickening (halt).An echocardiogram was performed the following day revealing the mean gradient had increased to 35 mmhg.Approximately one month later, the patient was hospitalized due to shortness of breath and increased work of breathing, where they were diagnosed with congestive heart failure (chf).The patient was started on anti-coagulation medicine, andwill return for a repeat echocardiogram to evaluate for potential further treatment options.
Additional Manufacturer Narrative
This report was impacted by emdr scheduled maintenance occurring july 22-27, 2026.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 ; +353(091)708096
• MDR Report Key: 50087326
• Report Number: 9617601-2026-04616
• Device Sequence Number: 13215533
• Product Code: NPT
• UDI-Device Identifier: 00763000370688
• UDI-Public: (01)00763000370688(17)241221
• 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: 2024
• 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): 08/24/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/21/2024
• Device Model Number: EVOLUTFX-23
• Device Catalogue Number: EVOLUTFX-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/24/2026
• Date Device Manufactured: 12/22/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 159 LB