BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNISCIENCE CARDIAC VALVE PROSTHESIS

    MDR report key: 376930 · Received February 16, 2002

    Report

    Report Number
    2124529-2002-00001
    Event Type
    Injury
    Date Received
    February 16, 2002
    Date of Event
    January 1, 1993
    Report Date
    January 18, 2002
    Manufacturer
    MEDICALCV, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SIZE 21 AORTIC VALVE WAS RETURNED FOR SCIENTIFIC EVAL 8 YEARS AFTER IT WAS EXPLANTED. SHORTLY AFTER THE VALVE PROSTHESIS WAS IMPLANTED, THE PT DEVELOPED SEVERE HYPOTENSION. THE SURGEON DECIDED TO REMOVE THE PROSTHESIS (ON THE SAME DAY IT WAS IMPLANTED). THE PT RECOVERED AND IS FINE. LAB EVAL FOUND THAT THE PROSTHESIS FUNCTIONED ACCORDING TO ITS SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNISCIENCE CARDIAC VALVE PROSTHESIS MECHANICAL REPLACEMENT HEART VALVE LWQ MEDICALCV, INC. 2312 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention