BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1362007 · Received April 15, 2009

    Report

    Report Number
    2015691-2009-10322
    Event Type
    Death
    Date Received
    April 15, 2009
    Report Date
    March 18, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE. NO RESPONSE WAS RECEIVED FROM THE SURGEON DESPITE OUR ATTEMPTS ON 03/19/2009 AND ON 03/26/2009 BY EMAIL TO CONTACT FOR RETURN OF PRODUCT AND ADDITIONAL INFORMATION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED ON 04/28/2009 AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES.

    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. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. PATIENT ALSO HAD ANOTHER VALVE, MODEL 2900 IMPLANTED. NO FURTHER DETAILS WERE PROVIDED. INFORMATION LEARNED FROM IMPLANT PATIENT REGISTRY.

    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 08E119

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Death