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

Model Number	EVPROPLUS-34US
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Insufficiency/ Regurgitation (4450); Hemodynamic instability (4868)
Date of Event	02/28/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported, approximately three years, 11 months following the implant of this transcatheter aortic bioprosthetic valve, the patient presented to an outside hospital.Upon assessment, complete hemodynamic instability was observed and severe central regurgitation was identified.The patient was admitted and extracorporeal membrane oxygenation was initiated.No further information was reported.
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.
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.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 during the hospitalization, a non-medtronic transcatheter aortic bioprosthetic valve was implanted and the patient was transferred to a different hospital.The cause of the severe central aortic regurgitation was unknown.Subsequently, the patient passed away shortly after.The cause of death was not reported.
Event or Problem Description
It was reported, approximately three years, 11 months following the implant of this transcatheter aortic bioprosthetic valve, the patient presented to an outside hospital.Upon assessment, complete hemodynamic instability was observed and severe central regurgitation was identified.The patient was admitted and extracorporeal membrane oxygenation was initiated.No further information was reported.Additional information was received that during the hospitalization, a non-medtronic transcatheter aortic bioprosthetic valve was implanted and the patient was transferred to a different hospital.The cause of the severe central aortic regurgitation was unknown.Subsequently, the patient passed away shortly after.The cause of death was not reported.Additional information was received that per the physician, the cause of death was unknown but the valve cannot be excluded as a contributing factor to the death.
Additional Manufacturer Narrative
Updated data: 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.
Additional Manufacturer Narrative
Correction: h6 - patient code and device code were erroneously omitted from the initial regulatory report.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 PLUS 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: 24590833
• Report Number: 9617601-2026-01799
• Device Sequence Number: 8828597
• Product Code: NPT
• UDI-Device Identifier: 00763000211158
• UDI-Public: (01)00763000211158(17)230805
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 04/27/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/05/2023
• Device Model Number: EVPROPLUS-34US
• Device Catalogue Number: EVPROPLUS-34US
• 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: 02/28/2026
• Supplement Date Received by Manufacturer: 03/13/2026; 03/31/2026; 04/27/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 03/31/2026; 04/22/2026; 04/27/2026
• Date Device Manufactured: 08/05/2021
• 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; Death; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male