BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    MDR report key: 1690771 · Received May 16, 2010

    Report

    Report Number
    2015691-2010-13375
    Event Type
    Death
    Date Received
    May 16, 2010
    Date of Event
    January 23, 2010
    Report Date
    April 15, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K020864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THE PATIENT ALSO HAD OTHER RELATED EVENTS; (B) (6). THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER (VIA FAX), THE OPERATIVE REPORT WAS RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 2.3 MONTHS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A RESPONSE WAS RECEIVED. UNFORTUNATELY, THE CAUSE OF DEATH WAS NOT PROVIDED. PER THE OPERATIVE REPORT OF (B) (6) 2009: THE PATIENT TOLERATED THE PROCEDURE WELL AND WILL BE BROUGHT TO THE INTENSIVE CARE UNIT IN STABLE CONDITION FOLLOWING THE PROCEDURE. THE PATIENT'S FAMILY WAS UPDATED ABOUT THE PATIENT'S CONDITION AND THE DIFFICULTY OF THE OPERATION, AS WELL AS INFORMED ABOUT THE FRAGILITY OF THE PATIENT'S TISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4900 R-09F1336

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death