BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS LIFESCIENCES

    MDR report key: 1317558 · Received February 20, 2009

    Report

    Report Number
    1317558
    Event Type
    Injury
    Date Received
    February 20, 2009
    Date of Event
    January 23, 2009
    Report Date
    February 12, 2009
    Manufacturer
    EDWARDS LIFESCIENCE LLC
    Product Code
    LWR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT. ADMITTED TO HOSPITAL FOR AORTIC VALVE REPLACEMENT. PROCEDURE TO PLACE VALVE. PT CONTINUED TO EXPERIENCE INSUFFICIENCY. VALVE REPLACED NINE DAYS LATER. (A FOLLOW-UP ECHO WAS COMPLETED, PRIOR TO THAT DAY, WHICH SHOWED A PERIVALVULAR LEAK THAT WAS NOT APPARENT IN THE OR WHEN VALVE PLACED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS LIFESCIENCES AORTIC VALVE BIO PROSTHETIC LWR EDWARDS LIFESCIENCE LLC 3000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention