BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 1315643 · Received February 11, 2009

    Report

    Report Number
    2015691-2009-09882
    Event Type
    Injury
    Date Received
    February 11, 2009
    Date of Event
    December 19, 2008
    Report Date
    January 21, 2009
    Manufacturer
    EDWARDS LIFESCIENCES, LLC.
    Product Code
    LWR
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 AFTER AN IMPLANT DURATION OF AT LEAST 133 MONTHS, DUE TO AORTIC INSUFFICIENCY. INFO LEARNED FROM THE OPERATIVE REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention