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

Model Number	MCS-P3-26-AOA-US
Medical Device Problem Codes	Gradient Increase (1270); Insufficient Device Problem Information (3190); Device Stenosis (4066)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Valvular Stenosis (2697); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that 9 years 3 months following the implant of this transcatheter bioprosthetic valve, the valve failed.The mechanism of failure was not provided.No adverse patient effects 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
Outcome attributed to adverse event updated b3.Date of event updated b5.Second paragraph added h1.Type of reportable event updated h6.Patient and device codes updated additional codes updated 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
Medtronic received information that 9 years 3 months following the implant of this transcatheter bioprosthetic valve, the valve failed.The mechanism of failure was not provided.No adverse patient effects were reported.Additional information was received that the patient experienced chest pain and shortness of breath with a new york heart association functional classification of iii.Valve stenosis was identified with a mean gradient of 45 mmhg.Subsequently, percutaneous coronary intervention was performed on the mid left anterior descending artery, and a second non-medtronic valve was implanted valve-in-valve.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Updated data: b5.Third paragraph 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
Medtronic received information that 9 years 3 months following the implant of this transcatheter bioprosthetic valve, the valve failed.The mechanism of failure was not provided.No adverse patient effects were reported.Additional information was received that the patient experienced chest pain and shortness of breath with a new york heart association functional classification of iii.Valve stenosis was identified with a mean gradient of 45 mmhg.Subsequently, percutaneous coronary intervention (pci) was performed on the mid left anterior descending artery, and a second non-medtronic valve was implanted valve-in-valve.No additional adverse patient effects were reported.Additional information was received that the patient had a history of coronary artery disease and a previous coronary artery occlusion.The pci was a planned intervention.

• 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: 19825233
• Report Number: 2025587-2024-04260
• Device Sequence Number: 12984675
• Product Code: NPT
• UDI-Device Identifier: 00643169448537
• UDI-Public: 00643169448537
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2024

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: 01/14/2017
• Device Model Number: MCS-P3-26-AOA-US
• Device Catalogue Number: MCS-P3-26-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: 07/22/2024
• Supplement Date Received by Manufacturer: 07/31/2024; 08/15/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/08/2024; 08/23/2024
• Date Device Manufactured: 02/05/2015
• 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: Required Intervention
• Patient Sex: Female