BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBOMEDIC TOP-HAT 25ML VALVE

    MDR report key: 2964177 · Received February 14, 2013

    Report

    Report Number
    MW5028981
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    February 22, 2010
    Report Date
    February 14, 2013
    Manufacturer
    SORIN
    Product Code
    DYE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010 PATIENT HAD AN AORTIC VALVE REPLACEMENT. THE IMPLANT WAS THE CARBOMEDICS TOP-HAT 25ML VALVE MANUFACTURED BY SORIN. IMMEDIATELY AFTER THE IMPLANT, PATIENT WAS FEELING GREAT UNTIL ABOUT 6 MONTHS AGO WHEN HE STARTED FEELING WEAK, DIZZY, WAS ALWAYS FALLING ASLEEP, EXPERIENCED CHEST PAIN, MIGRAINE, AND SHORTNESS OF BREATH ESPECIALLY WHEN LYING DOWN ON HIS BACK OR ON HIS SIDE. HE SAYS HE'S UP TO DATE WITH HIS MEDICAL EXAMS AND EKGS. LAST WEEK HIS DOCTOR TOLD HIM HIS AORTIC VALVE WAS REGURGITATING AND THEREFORE LEAKING. AND THAT THE LEFT SIDE OF HIS HEART WAS GRADUALLY SWELLING UP. HE'S WORRIED AND WILL LIKE FOR HIS VALVE TO BE CHECKED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65520 CARBOMEDIC TOP-HAT 25ML VALVE AORTIC VALVE DYE SORIN

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR