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 Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	07/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Additional information was received indicating that the patient is being evaluated for whether treatment is needed.
Event or Problem Description
It was reported that 4 years and 10 months following implantation of a transcatheter aortic valve, moderate central regurgitation was identified.Subsequently, the patient was hospitalized.
Additional Manufacturer Narrative
Image review: a case report and one 3mensio video clip from imaging services dated 07/29/2026 were provided.Report review: the patient is reported to have a 26 mm evolut pro+ valve implanted in september 2021.Evolut appears under expanded.Calcification is present outside the tav frame in the native non-coronary cusp (ncc) at approximately node 2/9.0 mm.Calcification is also seen within the tav frame.Possible pannus, thrombus, or inadequate contrast filling is noted within the tav frame at approximately 12.7 mm.Implant depth measures approximately 5.6 mm beneath the left coronary cusp (lcc) and 5.7 mm beneath the right coronary cusp (rcc).3mensio video clip review: the video clip scrolls through the computed tomography (ct) anatomy from the evolut inflow to outflow and confirms the findings described in the report.Updated b.5 and h.6 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
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: 50089989
• Report Number: 9617601-2026-04834
• Device Sequence Number: 10317466
• Product Code: NPT
• UDI-Device Identifier: 00763000211110
• UDI-Public: (01)00763000211110(17)230421
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 08/27/2026

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: 04/21/2023
• Device Model Number: EVPROPLUS-26US
• Device Catalogue Number: EVPROPLUS-26US
• 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: 07/29/2026
• Supplement Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/27/2026
• Date Device Manufactured: 04/21/2021
• 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
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 137 LB