BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1880726 · Received October 25, 2010

    Report

    Report Number
    2015691-2010-14254
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 24, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. CUSTOMER LETTER NOT REQUESTED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. NO ADDITIONAL PATIENT OR SURGEON INFORMATION IS AVAILABLE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE WAS EXPLANTED AT IMPLANT DUE TO UNKNOWN REASONS. THE REPLACEMENT DEVICE IS UNKNOWN. NO FURTHER DETAILS WERE PROVIDED. INFORMATION WAS LEARNED THROUGH (B)(4) IMPLANT PATIENT REGISTRY. THE DEVICE WILL NOT BE RETURNED, AS IT WAS DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 6900P 08B031

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R