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-29
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	11/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported approximately four years, seven and a half months following the implant of this 29mm transcatheter aortic bioprosthetic valve (tav) (serial number unknown), a multi-detector computed tomography was performed.The primary mode of valve failure was s tructural valve deterioration: predominant aortic regurgitation (ar) with severe hemodynamic valve deterioration.This was characterized by a new occurrence or increase of >=2 grades of intra-prosthetic aortic regurgitation resulting in >=severe ar.The patient was enrolled in a clinical study with existing, baseline valve failure to determine whether a redo-transcatheter aortic valve replacem ent procedure, tav-in-tav, was appropriate.Three weeks after the valve failure was identified, the patient was treated with re-intervention for the failed tav.A non-medtronic (edwards) valve was implanted within the medtronic tav.No patient symptoms prior to re intervention were reported and no complications were reported as a result of this event.
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
Additional information received indicated the baseline transthoracic echocardiogram (tte) measurements, prior to the valve-in-valve revision identified a max aortic valve velocity (v2) of 1.65 meters per second (m/sec), a mean aortic gradient (mgv2) of 5.94 millimeters of mercury (mm hg), an aortic valve area (ava) of 3.89 centimeters squared (cm2), severe total aortic prosthetic regurgitation, severe transvalvular regurgitation, moderate mitral regurgitation (mr) and mild tricuspid regurgitation (tr).
Additional Manufacturer Narrative
Updated data: a1, b5, d4, h4, h6 corrected data: b2, 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.

• 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: 23803089
• Report Number: 9617601-2025-03468
• Device Sequence Number: 18063764
• Product Code: NPT
• UDI-Device Identifier: 00763000017675
• UDI-Public: (01)00763000017675(17)210820
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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: 08/20/2021
• Device Model Number: EVOLUTR-29
• Device Catalogue Number: EVOLUTR-29
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/15/2026
• Date Device Manufactured: 09/05/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NO.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White