BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 1897139 · Received November 12, 2010

    Report

    Report Number
    2015691-2010-14361
    Event Type
    Death
    Date Received
    November 12, 2010
    Date of Event
    September 8, 2010
    Report Date
    October 14, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED. PATIENT HAD 2 OTHER DEVICES. (B)(4). 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

    AN EVENT WAS RECEIVED THROUGH THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY. THIS "REGISTRY" IS A PATIENT TRACKING MECHANISM FOR SERIALIZED DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET REGISTRY. PATIENT AND DEVICE STATUS ARE REPORTED THROUGH THE REGISTRY. THIS INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED BY EDWARDS AS A CONVENTIONAL CUSTOMER COMPLAINT. IN THIS CASE, THE PATIENT EXPIRED AFTER AN IMPLANT DURATION OF 38 DAYS (1.23 MONTHS) DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX 10F134

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| H| R