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

Model Number	EVPROPLUS-29US
Medical Device Problem Codes	Gradient Increase (1270); Perivalvular Leak (1457); Patient Device Interaction Problem (4001); Thickening of Material (4056); Device Stenosis (4066); Unspecified Valve Regurgitation (4080)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450); Transvalvular Pressure Gradient Increased (4854)
Date of Event	12/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 4 years following implantation of a transcatheter aortic valve, a computed tomography angiogram (cta) was obtained which indicated severe hypoattenuated leaflet thickening (halt).The patient was then prescribed warfarin and eliquis, both of which they did not tolerate.Eventually, the patient was transitioned to pradaxa.5 years and 5 months following implantation of the valve, a transthoracic echocardiogram (tte) was obtained which showed a ejection fraction of 55-60%.5 years and 6 months following implantation of the valve, a second tte was obtained that showed an ejection fraction of 35-40% and mild to moderate aortic valve regurgitation.The patient then presented to the emergency department 5 years and 7 months following implantation of the valve for dyspnea and generalized weakness.Subsequently, a third tte was obtained, which reflected an ejection fraction of 28% and a high aortic valve mean gradient of 71 millimeters of mercury (mm hg).Subsequently, the patient was admitted to the intensive care unit (icu) and was intubated due to acute hypoxic and hypercapnic respiratory failure.Additionally, the patient was started on a heparin drip due to suspected halt.Aortic stenosis was also noted as well as valve thrombosis and acute chronic heart failure.
Additional Manufacturer Narrative
B3: date is approximate.Month and year are confirmed valid.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 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 ; +353(091)708096
• MDR Report Key: 50083011
• Report Number: 9617601-2026-04602
• Device Sequence Number: 10320426
• Product Code: NPT
• UDI-Device Identifier: 00763000211127
• UDI-Public: (01)00763000211127(17)220117
• 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: 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
• 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: 01/17/2022
• Device Model Number: EVPROPLUS-29US
• Device Catalogue Number: EVPROPLUS-29US
• 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: 07/21/2026
• 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: 02/06/2020
• 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; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 157 LB