BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERICARDIAL BIOPROSTHESIS

    MDR report key: 1031225 · Received April 15, 2008

    Report

    Report Number
    6000002-2008-06530
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 7, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 36 MONTHS DUE TO STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 2700 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention