BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    MDR report key: 1850754 · Received October 2, 2010

    Report

    Report Number
    2015691-2010-14145
    Event Type
    Death
    Date Received
    October 2, 2010
    Date of Event
    June 9, 2010
    Report Date
    September 2, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K020864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT EXPLANTED. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THE PATIENT ALSO HAD TWO OTHER DEVICES IMPLANTED; PLEASE REFERENCE THE OTHER MEDWATCH REPORTS FILED UNDER PATIENT IDENTIFIER # (B)(4). THROUGH FOLLOW-UP, ADDITIONAL INFORMATION REGARDING THIS PATIENT WAS RECEIVED, HOWEVER, THE CAUSE OF DEATH WAS NOT PROVIDED. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN 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 1.87 MONTHS. THROUGH FOLLOW-UP WITH THE SURGEON'S OFFICE, ADDITIONAL INFORMATION REGARDING THIS PATIENT WAS RECEIVED. UNFORTUNATELY, THE CAUSE OF DEATH WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4900 R-10A0010

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death