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-34-US
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	12/23/2025
Type of Reportable Event	Death
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 5 years and 10 months following the implant of a transcatheter aortic valve, the patient was re-hospitalized due to stenosis of the valve.A valve-in-valve procedure was performed with a non-medtronic valve; however, the patient ultimately passed away due to complications related to the valve-in-valve procedure.It was noted that the medtronic valve was ultimately explanted.
Additional Manufacturer Narrative
Updated data: b5.A second paragraph was added.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 5 years and 10 months following the implant of a transcatheter aortic valve (tav), the patient was re-hospitalized due to stenosis of the valve.A tav-in-tav procedure was performed with a non-medtronic (edwards sapien) valve; however, the patient ultimately passed away due to complications related to the valve-in-valve procedure.It was noted that the transcatheter valve was ultimately explanted.Additional information was received to confirm the medtronic tav indirectly contributed to the patient's death.It was further noted if the medtronic tav had not failed, then no redo-tav replacement would not have been necessary.Ultimately, the non-medtronic (edwards sapien) tav going into the ventricle, and the complications from that, is what caused the patient's death.

• 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: 25302340
• Report Number: 9617601-2026-03425
• Device Sequence Number: 13091111
• Product Code: NPT
• UDI-Device Identifier: 00643169792340
• UDI-Public: (01)00643169792340(17)191031
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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
• Report Date (Section B): 06/24/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: EVOLUTR-34-US
• Device Catalogue Number: EVOLUTR-34-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: 05/22/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 06/24/2026
• Date Device Manufactured: 11/16/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Death; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male