BEUDAMED
    FDA Adverse Event Death Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM WITH DURAFLO TREATMENT

    MDR report key: 1403455 · Received June 18, 2009

    Report

    Report Number
    2015691-2009-10853
    Event Type
    Death
    Date Received
    June 18, 2009
    Date of Event
    January 24, 2009
    Report Date
    May 26, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K980487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT 08/21/2009, THERE HAS BEEN NO RESPONSE RECEIVED FROM THE SURGEON DESPITE OUR REPEATED ATTEMPTS TO CONTACT FOR RETURN OF PRODUCT AND ADDITIONAL INFORMATION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, 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 INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. A DEVICE HISTORY RECORD REVIEW IS IN PROCESS. TWO REQUESTS WERE MADE (VIA E-MAIL) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED AND NO DEVICE WAS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER A IMPLANT DURATION OF APPROXIMATELY 14.7 MONTHS DUE TO UNKNOWN REASONS. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. PATIENT ALSO HAD TWO OTHER DEVICES IMPLANTED. NO FURTHER DETAILS WERE PROVIDED.

    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-07F1290

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death