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-29-US
Medical Device Problem Codes	Gradient Increase (1270); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849); Aortic Valve Insufficiency/ Regurgitation (4450); Peripheral Edema (4578)
Date of Event	09/11/2025
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 9 years and 9 months following the implant of the transcatheter bioprosthetic aortic valve a severe hemodynamic valve deterioration was identified specific to a structural valve deterioration.This involved a new occurrence or an increase of =2 grades of intra-prosthetic aortic regurgitation resulting in severe aortic regurgitation.Seven days later a valve-in-valve revision occurred via the left femoral vein.A non-medtronic valve was successfully implanted.
Additional Manufacturer Narrative
Updated data: b2, b5, 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 received indicated prior to the valve-in-valve (viv) revision the patient experienced swelling in the lower extremities, fatigue, and shortness of breath.Hospitalization was required as result of the viv.The patient was discharged 18 days following admission.
Additional Manufacturer Narrative
Updated data: h6.Product analysis: as the device remained implanted in the patient at the time of the investigation, a product return analysis could not be conducted.Conclusion: a comprehensive review of the device history records for the suspect complaint device was performed.In this instance no manufacturing issues or signals, that may have been causative in considering this issue were identified.The device instructions for use (ifu) lists regurgitation and gradients as potential risks associated with the treatment procedures.The device ifu is developed from the product risk documentation as is the product labelled adverse events document.There was no identified inadequacy with the device ifu in relation to this event.Risk document review would not be applicable to the reported event.The complaint investigation determined this event is foreseen in risk management and is included in monitoring/trending.High gradients can be related to valve related factors (e.G.Degeneration, thrombus, calcification, etc.) or non-valve related facto rs (e.G.Left ventricle outflow tract obstruction, patient pressures, left ventricle dysfunction, etc.), but without review of echocardiographic imaging, an assignable root cause could not be determined.Post-implant occurrence of aortic regurgitation after an ext ended time period can be caused by a variety of factors, including changes to patient anatomy or pre-existing medical conditions.In this case, a root cause could not be determined.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 9 years and 9 months following the implant of the transcatheter bioprosthetic aortic valve a severe hemodynamic valve deterioration was identified specific to a structural valve deterioration.This involved a new occurrence or an increase of =2 grades of intra-prosthetic aortic regurgitation resulting in severe aortic regurgitation.Seven days later a valve-in-valve revision occurred via the left femoral vein.A non-medtronic valve was successfully implanted.Additional information received indicated prior to the valve-in-valve (viv) revision the patient experienced swelling in the lower e xtremities, fatigue, and shortness of breath.Hospitalization was required as result of the viv.The patient was discharged 18 days following admission.

• 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: 23301223
• Report Number: 9617601-2025-02025
• Device Sequence Number: 10028306
• Product Code: NPT
• UDI-Device Identifier: 00643169638006
• UDI-Public: (01)00643169638006(17)170927
• 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: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2025

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: 09/27/2017
• Device Model Number: EVOLUTR-29-US
• Device Catalogue Number: EVOLUTR-29-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: 09/18/2025
• Supplement Date Received by Manufacturer: 10/20/2025; 11/28/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/12/2025; 12/17/2025
• Date Device Manufactured: 10/13/2015
• 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: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White