BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVANOVA

    MDR report key: 9539120 · Received December 31, 2019

    Report

    Report Number
    MW5091968
    Event Type
    Injury
    Date Received
    December 31, 2019
    Date of Event
    December 14, 2019
    Report Date
    December 27, 2019
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LWR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LIVANOVA PERCEVAL VALVE WAS IMPLANTED - 18 MONTHS PRIOR TO PRESENTATION. THE VALVE HAD MIGRATED DISTALLY, CAUSING SEVERE PERIVALVULAR LEAK, CONGESTIVE HEART FAILURE, AND OBSTRUCTION OF THE RIGHT CORONARY ARTERY. DID NOT APPEAR TO BE UNDER OR OVER SIZED. THE PT REQUIRED REDO STERNOTOMY AND VALVE EXPLANT, REPLACEMENT WITH 27 MM EDWARDS MAGNA EASE VALVE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328640 LIVANOVA HEART-VALVE, NON ALLOGRAFT TISSUE LWR LIVANOVA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| O| S