BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS CLASSIC TRICUSPID ANNULOPLASTY RING

    MDR report key: 1707852 · Received June 2, 2010

    Report

    Report Number
    2015691-2010-13470
    Event Type
    Death
    Date Received
    June 2, 2010
    Report Date
    May 3, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K912554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER (VIA FAX), A RESPONSE WAS RECEIVED, HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. 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. THE DATE OF PATIENT'S DEATH AND IMPLANT DURATION ARE UNKNOWN. ON 05/15/2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), A RESPONSE WAS RECEIVED, HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS NOTED THAT THE SURGEON HAS NOT SEEN THE PATIENT SINCE 2002, AND HAS SINCE RELOCATED TO ANOTHER HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS CLASSIC TRICUSPID ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4500 1J1468

    Patients

    Seq Age Sex Outcome Treatment
    1 Death