BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER - EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 1170006 · Received September 12, 2008

    Report

    Report Number
    6000002-2008-08638
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Report Date
    August 29, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P86005/S001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THE EVENT WAS REPORTED BY THE PATIENT. DUE TO HIPPA REGULATIONS, WE ARE UNABLE TO PROVIDE YOU WITH THE PATIENT'S PERSONAL INFORMATION.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT AFTER A 5 MONTH DURATION, SHE HAS MODERATE STENOSIS. THE PATIENT WOULD LIKE TO KNOW HOW COMMON IS THIS. REPORTEDLY, THE 2ND ECHO AT 8 1/2 MONTHS STILL INDICATES MODERATE AORTIC STENOSIS WITH HIGHER GRADIENT NUMBERS.

    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 R-07E1104

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR