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 Codes	Fluid/Blood Leak (1250); Patient Device Interaction Problem (4001); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	10/21/2025
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 that approximately 7 years and 6 months following the implant of a transcatheter valve, a computed tomography (ct) scan and transesophageal echocardiogram (tee) were performed that revealed the valve failed due to possible moderate to severe aortic insufficiency.Additionally, a possible mobile echogenic structure on the valve leaflet was noted and reported to be possible thrombus/vegetation/mass.
Additional Manufacturer Narrative
Image review: echocardiogram findings include a mobile echogenic structure observed on the valve leaflets, with possible moderate to severe aortic insufficiency¿potentially involving two regurgitant jets identified in the short axis view.Additional findings include mild mitral regurgitation, moderate tricuspid regurgitation, and a possible pacemaker wire visualized in the right heart.Two separate video clips were provided, both confirming the presence of a mobile echogenic structure on the valve leaflets within the tav device, located near the non-coronary cusp (ncc).Updated b5.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 severe central aortic regurgitation was confirmed via echocardiogram.Medical treatment was not provided.
Additional Manufacturer Narrative
Updated data: b5.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
It was reported that approximately 7 years and 6 months following the implant of a transcatheter valve, a computed tomography (ct) scan and transesophageal echocardiogram (tee) were performed that revealed the valve failed due to possible moderate to severe aortic insufficiency.Additionally, a possible mobile echogenic structure on the valve leaflet was noted and reported to be possible thrombus/vegetation/mass.Additional information was received that severe central aortic regurgitation was confirmed via echocardiogram.Medical treatment was not provided.Additional information was received that approximately 7 years and 11 months following the implant of the valve, another computed tomography (ct) scan was performed for redo transcatheter aortic valve (tav) workup that revealed the valve failed.

• 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: 23536212
• Report Number: 9617601-2025-02689
• Device Sequence Number: 10026824
• Product Code: NPT
• UDI-Device Identifier: 00643169792340
• UDI-Public: (01)00643169792340(17)200118
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 03/25/2026

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: 01/18/2020
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 11/12/2025; 03/05/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/09/2025; 03/25/2026
• Date Device Manufactured: 02/06/2018
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 73 KG