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-US
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Restenosis (4576); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
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, approximately 10 years after the implant of this 29 mm transcatheter aortic bioprosthetic valve, in a patient with aortic stenosis (as) at baseline, the valve failed due to severe as with an ejection fraction of 45-50%.Of note, the patient had aleft atrial appendage with placement of an existing non-medtronic closure device with possible thrombus/plaque observed.No treatment plans were reported.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Updated data: b1.Adverse event and product problem.B2.Outcome attributed to adverse event.B5.A second paragraph was added.H1.The original information indicated the event was a reportable malfunction.Additional information indicates that intervention was required.The event is now a reportable serious injury.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported, approximately 10 years after the implant of this 29 millimeter (mm) transcatheter aortic bioprosthetic valve, in a patient with aortic stenosis (as) at baseline, the valve failed due to severe as with an ejection fraction of 45-50%.Of note, the patient had a left atrial appendage with placement of an existing non-medtronic closure device with possible thrombus/plaque observed.No treatment plans were reported.No patient complications were reported as a result of this event.Additional information was received that eight days later, a 26 mm non-medtronic transcatheter valve was implanted valve-in-valve.F ollowing this procedure, the patient was hospitalized due to vascular complications not revelated to the medtronic valve.

• 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: 24283431
• Report Number: 9617601-2026-01023
• Device Sequence Number: 8319054
• Product Code: NPT
• UDI-Device Identifier: 00643169638006
• UDI-Public: (01)00643169638006(17)171027
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 03/10/2026

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: 10/27/2017
• Device Model Number: EVOLUTR-29-US
• Device Catalogue Number: EVOLUTR-29-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: 02/02/2026
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2015
• 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 Sex: Female