BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 1242208 · Received November 18, 2008

    Report

    Report Number
    6000002-2008-09299
    Event Type
    Injury
    Date Received
    November 18, 2008
    Date of Event
    September 11, 2008
    Report Date
    November 10, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED APPROXIMATELY AFTER IMPLANT DURATION OF 89 MONTHS, DUE TO AORTIC STENOSIS. NO OTHER DETAILS WERE PROVIDED. INFO LEARNED PER RESPONSE FROM SURGEON.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention