BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 11307317 · Received February 10, 2021

    Report

    Report Number
    2025587-2021-00496
    Event Type
    Injury
    Date Received
    February 10, 2021
    Date of Event
    October 3, 2019
    Report Date
    February 10, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ØSTERGAARD L, VEJLSTRUP N, KØBER L, FOSBØL EL, SØNDERGAARD L, IHLEMANN N. DIAGNOSTIC POTENTIAL OF INTRACARDIAC ECHOCARDIOGRAPHY IN PATIENTS WITH SUSPECTED PROSTHETIC VALVE ENDOCARDITIS. J AM SOC ECHOCARDIOGR. 2019 DEC;32(12):1558-1564. DOI: 10.1016/J. ECHO.2019.06.016. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING THE DIAGNOSTIC POTENTIAL OF INTRACARDIAC ECHOCARDIOGRAPHY IN PATIENTS WITH SUSPECTED ENDOCARDITIS. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2012 AND DECEMBER 2016. THE STUDY POPULATION INCLUDED 38 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 74 YEARS). TWO OF WHOM WERE IMPLANTED WITH MEDTRONIC A MELODY TRANSCATHETER PULMONARY VALVE AND TWELVE OF WHOM WERE IMPLANTED WITH A MEDTRONIC COREVALVE TRANSCATHETER AORTIC VALVE (NO SERIAL NUMBERS PROVIDED). AMONG THE PATIENTS IMPLANTED WITH A COREVALVE, ADVERSE EVENTS INCLUDED ENDOCARDITIS, MODERATE TO SEVERE REGURGITATION AND MODERATE PARAVALVULAR LEAK (PVL). BASED ON THE AVAILABLE INFORMATION A MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204990 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization