BEUDAMED
    FDA Adverse Event Death Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM WITH DURAFLO TREATMENT

    MDR report key: 1252707 · Received December 2, 2008

    Report

    Report Number
    6000002-2008-09380
    Event Type
    Death
    Date Received
    December 2, 2008
    Report Date
    November 10, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K980487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    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. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. PATIENT ALSO HAD TWO OTHER DEVICES IMPLANTED. NO FURTHER DETAILS WERE PROVIDED. INFORMATION LEARNED FROM IMPLANT PATIENT REGISTRY. IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE, MODEL #4625, WAS IMPLANTED. REFER TO MFR REPORT# 6000002-2008-09379. IT WAS ADDITIONALLY REPORTED THAT A THIRD DEVICE, MODEL #2700, WAS IMPLANTED. REFER TO MFR REPORT#6000002-2008-09381.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM WITH DURAFLO TREATMENT ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4625 R-08D0707

    Patients

    Seq Age Sex Outcome Treatment
    1 Death