BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 1023252 · Received March 31, 2008

    Report

    Report Number
    6000002-2008-06381
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 14, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, THIS DEVICE WAS EXPLANTED AFTER APPROXIMATELY 97 MONTHS DUE TO AORTIC INSUFFICIENCY AND AORTIC STENOSIS.

    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 UNK Required Intervention