MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	EVPROPLUS-23US
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Thickening of Material (4056); Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Dyspnea (1816); Thrombosis/Thrombus (4440); Aortic Valve Insufficiency/ Regurgitation (4450); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
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 that approximately 3 years and 1 month following the implant of this transcatheter bioprosthetic valve, valve stenosis was noted.The site also reported hypo-attenuated leaflet thickening with measurements at 3 mm at the right coronary cusp, 1.5 mm at the left coronary cusp, and 3 mm at the non-coronary cusp.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Updated data: a4.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 was received that a transesophageal echocardiogram (tee) was performed revealing the valve was well seated, and all 3 leaflets were moving without restriction.There was moderate central aortic regurgitation with an eccentric jet.The patient was being worked up for a valve-in-valve procedure.
Event or Problem Description
It was reported that approximately 3 years and 1 month following the implant of this transcatheter bioprosthetic valve, valve stenosis was noted.The site also reported hypo-attenuated leaflet thickening with measurements at 3 mm at the right coronary cusp, 1.5 mm at the left coronary cusp, and 3 mm at the non-coronary cusp.No patient complications have been reported as a result of this event.Additional information was received that a transesophageal echocardiogram (tee) was performed revealing the valve was well seated, and all 3 leaflets were moving without restriction.There was moderate central aortic regurgitation with an eccentric jet.The patient was being worked up for a valve-in-valve procedure.Additional information was received indicating that the bioprosthetic aortic valve dysfunction appears to be clearly symptomatic with ongoing progressive dyspnea as well as new onset orthopnea.Per the physician this is due to the significant premature leaflet degeneration causing the significant regurgitation.Per the physician, the initial insult appeared to be under-expansion of the leaflets causing hypo-attenuated leaflet thickening and early subclinical thrombosis.The patient was tolerating antiplatelet and nonsteroidal anti-inflammatory drugs, but more robust anti-platelet medications were required.
Additional Manufacturer Narrative
Updated data: b1, b2, b5.Added third paragraph, h1, 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.

• Brand Name: EVOLUT PRO PLUS VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22088494
• Report Number: 2025587-2025-03893
• Device Sequence Number: 12489285
• Product Code: NPT
• UDI-Device Identifier: 00763000211103
• UDI-Public: 00763000211103
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 07/22/2025

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: 03/26/2023
• Device Model Number: EVPROPLUS-23US
• Device Catalogue Number: EVPROPLUS-23US
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 05/28/2025; 07/16/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/24/2025; 07/22/2025
• Date Device Manufactured: 03/26/2021
• 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: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 54 KG