MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	EVOLUTR-23-US
Medical Device Problem Codes	Gradient Increase (1270); Insufficient Device Problem Information (3190); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Insufficiency/ Regurgitation (4450); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
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
Medtronic received information from the patient that immediately following the implant of this transcatheter bioprosthetic valve, inside a previously implanted non-medtronic valve, the patient's mean gradient was 12 millimeters of mercury (mm hg).5 years and 1 month following implant, the patient had a recent echocardiogram that revealed a maximum gradient of 35 millimeters of mercury (mm hg) and a mean gradient of 19 mmhg.No symptoms were reported, and no treatment was reported or planned.No adverse patient effects were reported.Additional information was received that approximately 6 years and 1 month following the implant of this transcatheter aortic valve (tav), a computed tomography (ct) scan was performed that revealed the valve failed due to an unknown reason.Subsequently, the patient was evaluated for a possible tav in tav.
Additional Manufacturer Narrative
Updated data: b1.B2.B5.H1.The original information indicated the event was a reportable malfunction.Additional information indicates that a life threatening injury occurred.The event is now a reportable serious injury.H6.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.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
Medtronic received information from the patient that immediately following the implant of this transcatheter bioprosthetic valve, inside a previously implanted non-medtronic valve, the patient's mean gradient was 12 millimeters of mercury (mm hg).(b)(6) following implant, the patient had a recent echocardiogram that revealed a maximum gradient of 35 millimeters of mercury (mm hg) and a mean gradient of 19 mmhg.No symptoms were reported, and no treatment was reported or planned.No adverse patient effects were reported.Additional information was received that approximately (b)(6) following the implant of this transcatheter aortic valve (tav), a computed tomography (ct) scan was performed that revealed the valve failed due to an unknown reason.Subsequently, the patient was evaluated for a possible tav in tav.Additional information was received that the valve failed due to moderate-severe central aortic regurgitation, and there is no tav in tav planned.

• Brand Name: EVOLUT R TRANSCATHETER AORTIC VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24619244
• Report Number: 2025587-2026-00286
• Device Sequence Number: 9586275
• Product Code: NPT
• UDI-Device Identifier: 00763000017651
• UDI-Public: (01)00763000017651(17)200920
• 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: 2019
• 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): 04/17/2026

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: 09/20/2020
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/17/2026
• Date Device Manufactured: 10/10/2018
• 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
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 95 KG