BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS

    MDR report key: 1013326 · Received March 12, 2008

    Report

    Report Number
    6000002-2008-06194
    Event Type
    Other
    Date Received
    March 12, 2008
    Date of Event
    June 1, 2007
    Report Date
    November 8, 2007
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY PT WAS HOSPITALIZED DUE TO CALCIFICATION OF THE CUSPS, AORTIC STENOSIS SURFACE 0.9CM2. DEVICE WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 2650 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization