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

Model Number	EVOLUTPRO-29-US
Medical Device Problem Codes	Calcified (1077); Fluid/Blood Leak (1250); Gradient Increase (1270); Patient Device Interaction Problem (4001); Device Stenosis (4066)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Aortic Valve Insufficiency/ Regurgitation (4450); Tricuspid Valve Insufficiency/ Regurgitation (4453); Insufficient Information (4580); Transvalvular Pressure Gradient Increased (4854)
Date of Event	11/05/2025
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 seven years, eight months following the implant of this 29mm transcatheter aortic bioprosthetic valve (tav), valve failure was reported.The primary mode of valve failure was structural valve deterioration: predominant aortic regurgitation 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.The patient was enrolled in a clinical study with existing, baseline valve failure to determine whether a redo-tav replacement procedure, tav-in-tav, was appropriate.
Additional Manufacturer Narrative
The event now meets criteria for serious injury (from previous malfunction report type).Corrected data: h6 - aortic stenosis no longer applies to this 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.
Event or Problem Description
Additional information indicated that leaflet calcification and moderate tricuspid regurgitation were identified on the transthoracic echocardiogram (tte).Patient symptoms were not reported as result of this event.A valve-in-valve procedure was performed.A non-medtronic valve was implanted.
Additional Manufacturer Narrative
Updated data: b2.B5.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
Additional information was received that the patient was discharged home the day after the valve-in-valve procedure.
Event or Problem Description
Additional information was received that a core lab assessment identified thrombosis in the native sinus of the redo tav.The thromb osis was observed on the post-implant computed tomography (ct), that was performed one day following the tav-in-tav.The primary investigator at the implant facility, reviewed the imaging and confirmed the thrombosis.Per the physician, the thrombosis was possibly related to the redo tavr procedure and the non-medtronic tav.
Additional Manufacturer Narrative
Updated data: b5 b7 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 PRO 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: 23970808
• Report Number: 9617601-2026-00060
• Device Sequence Number: 7874789
• Product Code: NPT
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/23/2026

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: 11/24/2019
• Device Model Number: EVOLUTPRO-29-US
• Device Catalogue Number: EVOLUTPRO-29-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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: 01/07/2026; 02/02/2026; 08/24/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/02/2026; 02/26/2026; 09/23/2026
• Date Device Manufactured: 12/11/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 183 LB
• Patient Race: White