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	Fluid/Blood Leak (1250); Gradient Increase (1270); Perivalvular Leak (1457); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Thickening of Material (4056); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Stenosis (2263); Thrombosis/Thrombus (4440)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
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 6 months following the implant of a transcatheter valve, a computed tomography (ct) scan was performed that revealed the valve failed due to an unknown reason.Additionally, possible thrombus/pannus formation inside the valve frame was also observed.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Updated data: b5.B6.B7.E1.E4 email.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
Additional information was received that 5 years and 3 months following the implant of the valve, a transthoracic echocardiogram (tte) was performed that revealed moderate mitral regurgitation, aortic valve stenosis, and moderate aortic regurgitation.5 years and 5 months following the implant of the valve, a transesophageal echocardiogram (tee) was performed that revealed a mean aortic gradient of 15.1 millimeters of mercury (mm hg), and mild paravalvular leak (pvl).The patient was being evaluated for treatment options and a follow up echocardiogram would be performed in 6 months.
Event or Problem Description
It was reported that approximately 5 years and 6 months following the implant of a transcatheter valve, a computed tomography (ct) scan was performed that revealed the valve failed due to an unknown reason.Additionally, possible thrombus/pannus formation inside the valve frame was also observed.No patient complications were reported as a result of this event.Additional information was received that 5 years and 3 months following the implant of the valve, a transthoracic echocardiogram (tte) was performed that revealed moderate mitral regurgitation, aortic valve stenosis, and moderate aortic regurgitation.5 years and 5 months following the implant of the valve, a transesophageal echocardiogram (tee) was performed that revealed a mean aortic gradient of 15.1 millimeters of mercury (mm hg), and mild paravalvular leak (pvl).The patient was being evaluated for treatment options and a follow up echocardiogram would be performed in 6 months.Additional information was received that the moderate regurgitation was central.
Additional Manufacturer Narrative
Updated: b5.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: 23794198
• Report Number: 9617601-2025-03448
• Device Sequence Number: 5522198
• Product Code: NPT
• UDI-Device Identifier: 00763000017651
• UDI-Public: (01)00763000017651(17)200710
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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
• Report Date (Section B): 02/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2020
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 12/12/2025; 01/21/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/07/2026; 02/17/2026
• Date Device Manufactured: 07/30/2018
• 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
• Patient Age: 82 YR
• Patient Sex: Male