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	Perivalvular Leak (1457); Patient Device Interaction Problem (4001); Thickening of Material (4056); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Thrombosis/Thrombus (4440); Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	12/08/2025
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 approximately eight years, four months following the implant of this 34mm transcatheter aortic bioprosthetic valve (tav), valve failure was reported.The primary mode of valve failure was structural valve deterioration: predominant aortic regurgitation (ar) with severe hemodynamic valve deterioration.This was characterized by a new occurrence or increase of >=2 grades of intra-prosthetic aortic regurgitation resulting in >=severe central ar.The patient was admitted and enrolled in a clinical study with existing, baseline valve failure to determine whether a redo-transcatheter aortic valve replacement procedure, tav-in-tav, was appropriate.Pre-intervention imaging was obtained which showed possible left atrial appendage thrombus versus inadequate contrast filling.Additionally, possible pannus/thrombus and leaflet thickening versus inadequate contrast filling seen inside of the tav frame.Plaque/thrombus was noted in the right circumflex iliac artery and possible plaque/thrombus seen in the native sinuses.Four days after the valve failure was identified, the patient was treated with re-intervention for the failed tav.A non-medtronic (edwards sapien) valve was implanted within the medtronic tav.No patient symptoms prior to reintervention were reported and no complications were reported as a result of this event.
Event or Problem Description
Additional information received indicated that the study baseline transthoracic echocardiogram (tte) identified a mean aortic gradient (mgv2) of 7.95 millimeters of mercury (mm hg), an aortic valve area (ava) of 2.52 centimeters squared (cm2), a max aortic valve velocity (v2) of 1.99 meters per second (m/sec), severe total aortic prosthetic regurgitation with severe prosthetic transvalvular regurgitation.Mild mitral regurgitation (mr) and mild tricuspid regurgitation (tr) were also present.
Additional Manufacturer Narrative
Updated data: b5, h6 corrected data: 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 which indicated that mild paravalvular leak was present immediately after the index tav implant procedure.
Additional Manufacturer Narrative
Updated data: b5.H6.H6.The codes present in section h6.Correspond to multiple components/products that comprise this reported event.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 ; +353 091708096
• MDR Report Key: 23967276
• Report Number: 9617601-2026-00054
• Device Sequence Number: 15788508
• Product Code: NPT
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2026

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: 11/09/2018
• 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 04/09/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/09/2026; 05/06/2026
• Date Device Manufactured: 11/28/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NO; NO.
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 185 LB
• Patient Race: White