BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 1685475 · Received May 12, 2010

    Report

    Report Number
    2015691-2010-13333
    Event Type
    Death
    Date Received
    May 12, 2010
    Report Date
    April 12, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. THE PATIENT ALSO HAD ANOTHER VALVE IMPLANTED; (B) (6). THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER (VIA FAX), A RESPONSE WAS RECEIVED. NOT ADDITIONAL INFORMATION REGARDING THE EVENT WAS PROVIDED. ALSO CALLED FOR THE OPERATIVE REPORT, HOWEVER, WAS TOLD THAT IT WAS UNAVAILABLE. 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 04/20/2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), A RESPONSE WAS RECEIVED. UNFORTUNATELY, THE CAUSE OF DEATH WAS NOT PROVIDED. NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900PTFX R-09F1324

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| R