BEUDAMED
    FDA Adverse Event Death Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM WITH DURAFLO TREATMENT

    MDR report key: 1427674 · Received August 4, 2009

    Report

    Report Number
    2015691-2009-11249
    Event Type
    Death
    Date Received
    August 4, 2009
    Date of Event
    November 6, 2006
    Report Date
    June 22, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K980487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ON 07/17/2009 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), A COPY OF THE OPERATIVE REPORT WAS RECEIVED. UNFORTUNATELY, THE CAUSE OF DEATH REMAINS UNKNOWN. ON 08/21/2009 (THROUGH ADDITIONAL FOLLOW-UP), IT WAS LEARNED THAT THE DATE OF DEATH WAS 2006. PATIENT EXPIRED AFTER AN IMPLANT DURATION OF 0.8 MONTHS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. TWO REQUESTS WERE MADE VIA FAX FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED AND NO DEVICE WAS RETURNED FOR EVALUATION. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED. THE DATE OF PATIENTS' DEATH AND IMPLANT DURATION ARE UNKNOWN, IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED. PATIENT ALSO HAD A PATCH IMPLANTED.

    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 6D0724

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death