BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    MDR report key: 1666317 · Received April 25, 2010

    Report

    Report Number
    2015691-2010-13215
    Event Type
    Death
    Date Received
    April 25, 2010
    Date of Event
    December 24, 2009
    Report Date
    March 26, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED; DEVICE REMAINS IMPLANTED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE PATIENT ALSO HAD TWO OTHER DEVICES IMPLANTED; (B) (6). THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A COPY OF THE DISCHARGE SUMMARY WAS RECEIVED. 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 0.3 MONTHS, DUE TO UNKNOWN REASONS. THROUGH FOLLOW- UP WITH THE HEALTH-CARE PROVIDER, A COPY OF THE DISCHARGE SUMMARY WAS RECEIVED. PER THE DISCHARGE SUMMARY: "... THE FAMILY WAS CALLED TO VISIT THE PATIENT, THE CONDITION WAS TOO DETERIORATED DESPITE THE MAXIMAL MEDICAL CARE ADMINISTERED, THE PATIENT EXPIRED AT 9:23 AM."

    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-09K2367

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death