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

Model Number	MCS-P3-31-AOA-US
Medical Device Problem Codes	Fluid/Blood Leak (1250); Gradient Increase (1270); Perivalvular Leak (1457)
Health Effect - Clinical Codes	Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450); Transvalvular Pressure Gradient Increased (4854)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date is approximate.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 eight years, ten months following the implant of this transcatheter aortic bioprosthetic valve, the patient presented for a routine follow-up with the primary cardiologist.The patient reported worsening shortness of breath.A transthoracic echocardiogram was performed and it showed a worsening aortic valve mean gradient of 39mm hg; this was an increase from previous results of 15mm hg.Subject was started on a diuretic medication and was referred to structural heart clinic for evaluation for potential redo transcatheter aortic valve replacement.
Event or Problem Description
Additional information received indicated that unspecified regurgitation was also present.An unspecified valve intervention occurred approximately 2 months following onset of this event.Hospitalization was required.
Additional Manufacturer Narrative
Updated data: b2, b5, d4, 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
Updated data: b3.Date of event b5.A third paragraph was added.H6.Additional codes were added.Additional codes.An annex g code was added.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 eight years, ten months following the implant of this transcatheter aortic bioprosthetic valve, the patient presented for a routine follow-up with the primary cardiologist.The patient reported worsening shortness of breath (sob).A transthoracic echocardiogram was performed and it showed a worsening aortic valve mean gradient of 39mm hg, this was an increase from previous results of 15mm hg.Subject was started on a diuretic medication and was referred to structural heart clinic for evaluation for potential redo transcatheter aortic valve replacement.Additional information received indicated that unspecified regurgitation was also present.An unspecified valve intervention occurred approximately 2 months following onset of this event.Hospitalization was required.Additional information was received to note the onset of the patient's symptoms of worsening sob was approximately eight years, nine months following the valve implant procedure.The patient presented for the routine follow up appointment approximately three weeks after the sob onset.The regurgitation observed was mild paravalvular leak.The patient was admitted approximately one month, three weeks later for the transcatheter aortic valve replacement valve-in-valve (viv) procedure.The medtronic valve remains in the patient but replaced by a 26mm non-medtronic (edwards sapien 3 ultra) valve.One day following the viv, the worsening aortic valve gradient resolved and the patient was discharged to home.

• 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: 22202491
• Report Number: 2025587-2025-04220
• Device Sequence Number: 20524253
• Product Code: NPT
• UDI-Device Identifier: 00643169448551
• UDI-Public: (01)00643169448551(17)180126(21)B510627
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 08/29/2025

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: 01/26/2018
• Device Model Number: MCS-P3-31-AOA-US
• Device Catalogue Number: MCS-P3-31-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: 05/21/2025
• Supplement Date Received by Manufacturer: 07/08/2025; 08/04/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 08/01/2025; 08/29/2025
• Date Device Manufactured: 02/10/2016
• 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 Sex: Male
• Patient Weight: 76 KG