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

Model Number	EVOLUTR-23-US
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Valvular Stenosis (2697); Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580)
Date of Event	11/04/2025
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 8 years following the implant of a transcatheter valve, a computed tomography (ct) scan was performed that revealed the valve failed for an unknown reason.Subsequently, the patient was evaluated for a transcatheter aortic valve-in-transcatheter aortic valve replacement.No patient complications were reported as a result of this event.
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.
Event or Problem Description
It was reported that approximately 8 years following the implant of a transcatheter valve, a computed tomography (ct) scan was performed that revealed the valve failed for an unknown reason.Subsequently, the patient was evaluated for a transcatheter aortic valve-in-transcatheter aortic valve replacement.No patient complications were reported as a result of this event.Additional information was received that the failure was due to stenosis and no treatment has been planned.
Additional Manufacturer Narrative
Updated data: a4.Weight in lbs.B1.Adverse event and product problem.B2.Outcome attributed to adverse event.B5.A third paragraph was added.H1.Serious injury.H6.Annex e code, annex a code.Additional codes.Corrected data: d10.There is no concomitant product associated with this event.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 8 years following the implant of a transcatheter valve, a computed tomography (ct) scan was performed that revealed the valve failed for an unknown reason.Subsequently, the patient was evaluated for a transcatheter aortic valve-in-transcatheter aortic valve replacement.No patient complications were reported as a result of this event.Additional information was received that the failure was due to stenosis and no treatment has been planned.Additional information was received that approximately 8 years and 1 month following the implant of the valve, severe central aortic regurgitation was observed.Subsequently, a second transcatheter valve was implanted valve-in-valve, and the severity of the regurgitation changed to trace.
Additional Manufacturer Narrative
Updated: b2, b5, d6b, 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.
Event or Problem Description
It was reported that approximately 8 years following the implant of a transcatheter valve, a computed tomography (ct) scan was performed that revealed the valve failed for an unknown reason.Subsequently, the patient was evaluated for a transcatheter aortic valve-in-transcatheter aortic valve replacement.No patient complications were reported as a result of this event.Additional information was received that the failure was due to stenosis and no treatment has been planned.Additional information was received that approximately eight years, one and one half months following the implant of the valve, severe central aortic regurgitation was observed.Subsequently, a second tav was implanted valve-in-valve, and the severity of the regurgitation reduced to trace.Additional information was received that the when the patient was admitted to the hospital for valve replacement, the initial valve was explanted and the new transcatheter valve was implanted during an open surgical procedure following the explant.

• Brand Name: EVOLUT R TRANSCATHETER AORTIC 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: 23635599
• Report Number: 9617601-2025-02964
• Device Sequence Number: 13335065
• Product Code: NPT
• UDI-Device Identifier: 00643169637986
• UDI-Public: (01)00643169637986(17)190809
• 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: 2017
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 02/06/2026

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: 08/09/2019
• Device Model Number: EVOLUTR-23-US
• Device Catalogue Number: EVOLUTR-23-US
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 11/24/2025; 12/20/2025; 01/19/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/10/2025; 01/18/2026; 02/06/2026
• Date Device Manufactured: 08/22/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NO.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 39 KG