BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 1436994 · Received August 12, 2009

    Report

    Report Number
    2015691-2009-11305
    Event Type
    Injury
    Date Received
    August 12, 2009
    Date of Event
    July 13, 2009
    Report Date
    July 14, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED ON 08/14/09; HOWEVER, OUR LABORATORY WILL NOT PERFORM AN EVALUATION ON VALVES WITH INFECTED VALVES PER EDWARDS POLICY. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED ON 08/24/09, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. A DEVICE HISTORY RECORD REVIEW IS CURRENTLY IN PROCESS. REQUESTS WERE MADE VIA E-MAIL FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED, DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    REPORTEDLY AN EDWARDS DEVICE OF UNKNOWN MODEL AND SIZE WAS EXPLANTED IN 2009 DUE TO VALVE WAS SIGNIFICANTLY STENOTIC WITH 2 OF 3 LEAFLETS FROZEN AFTER A 4 YEAR IMPLANT DURATION. REPORTER IS TO OBTAIN MORE INFORMATION FROM THE DR. ON 07/17/09 ADDITIONAL INFORMATION RECEIVED FROM REPORTER INDICATES, THE PATIENT WAS A PREVIOUS DRUG USER, BEFORE THE FIRST IMPLANT. HE IS CURRENTLY ON AN ANTI VIRAL DRUG FOR HEPATITIS AND ALSO INTERFERON. PATIENT IS ALSO ON CUMADEN. AFTER AND 4 YEAR IMPLANT DURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3H1360

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention