BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE AORTIC 21MM

    MDR report key: 8794644 · Received July 15, 2019

    Report

    Report Number
    MW5088174
    Event Type
    Injury
    Date Received
    July 15, 2019
    Date of Event
    June 19, 2019
    Report Date
    July 10, 2019
    Manufacturer
    SORIN GROUP ITALIA S.R.L. / LIVANOVA USA, INC.
    Product Code
    PMA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SYMPTOMATIC SEVERE BIOPROSTHETIC AORTIC STENOSIS AND PT STATUS POST-SURGICAL AORTIC VALVE REPLACEMENT IN 2016 WITH SORIN 21 MM MITROFLOW BOVINE PERICARDIAL TISSUE VALVE. PROSTHETIC AORTIC VALVE STENOSIS WITH PEAK TRANSVALVULAR VELOCITIES > 5M/S. PLANS HAVE BEEN MADE FOR REDO AORTIC VALVE REPLACEMENT WITH DR (B)(6) ON (B)(6) 2019. FYI (PT DECLINED GIVING HER RACE / ETHNICITY ON ADMISSION). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585737 VALVE AORTIC 21MM HEART - VALVE, NON-ALLOGRAFT TISSUE PMA SORIN GROUP ITALIA S.R.L. / LIVANOVA USA, INC. J6B928

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention