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

Model Number	EVPROPLUS-26US
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Stroke/CVA (1770); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
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 5 years and 11 months following the implant of a transcatheter aortic valve, the valve failed due to aortic stenosis.The patient suffered a stroke as a result, and is being evaluated for a potential thrombus.
Event or Problem Description
It was reported that approximately 5 years and 11 months following the implant of a transcatheter aortic valve (tav), the valve failed due to aortic stenosis.The patient suffered a stroke as a result, and is being evaluated for a potential thrombus.Additional information was received that the stroke symptoms presented when the patient was hospitalized on the same day the valve failure was identified.The stroke was confirmed via computed tomography (ct) scan, neurological assessment, and magnetic resonance imaging (mri).The ct scan and echocardiogram did not show any signs of hypoattenuated leaflet thickening (halt).Per the physician, it was unknown whether the stroke was related to the valve.Approximately 3 weeks following hospitalization, another ct scan was performed that revealed moderate central aortic regurgitation.Subsequently, the patient was evaluated for a tav in tav, or explant, and the patient remains inpatient at the hospital.
Additional Manufacturer Narrative
Updated data: b2.B5.H6.Additional codes.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
Updated data: b2, b5, additional codes.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 5 years and 11 months following the implant of a transcatheter aortic valve (tav), the valve failed due to aortic stenosis.The patient suffered a stroke as a result, and is being evaluated for a potential thrombus.Additional information was received that the stroke symptoms presented when the patient was hospitalized on the same day the valve failure was identified.The stroke was confirmed via computed tomography (ct) scan, neurological assessment, and magnetic resonance imaging (mri).The ct scan and echocardiogram did not show any signs of hyperattenuated leaflet thickening (halt).Per the physician, it was unknown whether the stroke was related to the valve.Approximately 3 weeks following hospitalization, another ct scan was performed that revealed moderate central aortic regurgitation.Subsequently, the patient was evaluated for a tav in tav, or explant, and the patient remains inpatient at the hospital.Additional information was received that the patient underwent catheterization and is waiting for replacement of the transcatheter valve.

• Brand Name: EVOLUT PRO PLUS 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: 24472054
• Report Number: 9617601-2026-01490
• Device Sequence Number: 10308969
• Product Code: NPT
• UDI-Device Identifier: 00763000211110
• UDI-Public: (01)00763000211110(17)211112
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2026

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: 11/12/2021
• Device Model Number: EVPROPLUS-26US
• Device Catalogue Number: EVPROPLUS-26US
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 03/02/2026; 03/25/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/20/2026; 04/09/2026
• Date Device Manufactured: 12/03/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 88 YR
• Patient Sex: Female