MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION COREVALVE TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	MCS-P3-29-AOA-US
Medical Device Problem Code	Gradient Increase (1270)
Health Effect - Clinical Code	Transvalvular Pressure Gradient Increased (4854)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported approximately ten years, three and a half months following the implant of a transcatheter aortic bioprosthetic valve replacement procedure, the patient was enrolled in a clinical study with existing, baseline valve failure to determine whether a re do-transcatheter aortic valve replacement procedure, valve-in-valve, is appropriate.The study characterized the failure as structural valve deterioration with a severe increase in the mean aortic gradient which was >20mm hg at baseline and now >30mm hg.No patient symptoms were 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: b1, b2, b5, h1, h6 h1: updated to serious injury due to report of an intervention.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 that an unspecified intervention occurred.
Additional Manufacturer Narrative
Updated data: b2, b5, h6 - annes f corrected data: b3.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 that eight days following the identification of the failed valve, a redo valve-in-valve procedure occurred and required hospitalization.The second valve implanted was a non-medtronic aortic valve.The patient was discharged two days after the valve-in-valve procedure.

• Brand Name: COREVALVE TRANSCATHETER AORTIC 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: 22687427
• Report Number: 2025587-2025-05454
• Device Sequence Number: 15844375
• Product Code: NPT
• UDI-Device Identifier: 00643169448544
• UDI-Public: (01)00643169448544(17)161126
• 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: 2015
• 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
• Report Date (Section B): 09/24/2025

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: 11/26/2016
• Device Model Number: MCS-P3-29-AOA-US
• Device Catalogue Number: MCS-P3-29-AOA-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: 07/09/2025
• Supplement Date Received by Manufacturer: 08/01/2025; 08/28/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 08/27/2025; 09/24/2025
• Date Device Manufactured: 12/08/2014
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 67 KG