MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV EVOLUT FX VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	EVOLUTFX-29
Medical Device Problem Codes	Gradient Increase (1270); Perivalvular Leak (1457); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453); Insufficient Information (4580); Transvalvular Pressure Gradient Increased (4854)
Date of Event	09/16/2024
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
It was reported following the implant of this 29mm transcatheter aortic bioprosthetic valve (tav), mild paravalvular leak (pvl) was noted.No treatment was required.Approximately one year, one month, three weeks following valve implant, 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 an increase in mean gradient of >=20mm hg from baseline and a mean gradient of >=30mm hg.An additional mode of valve failure was also mentioned: non-structural valve dysfunction, pvl of the aortic valve.The patient was 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.One and a half months after the valve failure was identified, the patient was treated with re-intervention for the failed tav.A non-medtronic (edwards) 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.
Additional Manufacturer Narrative
Updated data: 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.
Event or Problem Description
Additional information was received that following the redo tav implant, the mean gradient was 6 mmhg.
Additional Manufacturer Narrative
Updated data: b2.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received that prior to the redo tav, a baseline transthoracic echocardiogram was performed and revealed a mean aortic gradient of 12.23 mmhg, aortic valve area of 1.69 cm2, max velocity of 2.32 m/sec, severe total aortic prosthetic regurgitation, severe transvalvular regurgitation, and mild tricuspid and mitral regurgitation.
Additional Manufacturer Narrative
Corrected data: b3, 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.

• Brand Name: EVOLUT FX 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: 23860474
• Report Number: 9617601-2025-03648
• Device Sequence Number: 21233760
• Product Code: NPT
• UDI-Device Identifier: 00763000370701
• UDI-Public: (01)00763000370701(17)260221
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup
• Report Date (Section B): 03/23/2026

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: 02/21/2026
• Device Model Number: EVOLUTFX-29
• Device Catalogue Number: EVOLUTFX-29
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 12/22/2025; 02/25/2026; 03/05/2026
• Initial Report FDA Received Date: 12/21/2025
• Supplement Report FDA Received Date: 01/16/2026; 02/25/2026; 03/23/2026
• Date Device Manufactured: 02/22/2024
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 82 YR
• Patient Sex: Male