BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 682624 · Received March 1, 2006

    Report

    Report Number
    6000002-2006-00102
    Event Type
    Injury
    Date Received
    March 1, 2006
    Date of Event
    January 23, 2006
    Report Date
    January 30, 2006
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS VALVE WAS EXPLANTED AFTER APPROXIMATELY A 43 MONTH IMPLANT DURATION DUE TO "ONE LEAFLET BEING FROZEN SOLID".J IT WAS ALSO STATED THAT THIS VALVE WAS SEWN INTO A CONDUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 2800 2E1013

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention