BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC HALL PROSTHETIC HEART VALVE

    MDR report key: 296843 · Received September 18, 2000

    Report

    Report Number
    6000026-2000-00018
    Event Type
    Injury
    Date Received
    September 18, 2000
    Report Date
    August 25, 2000
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTED IN JOURNAL ARTICLE: "INTERMITTENT ELECTROMECHANICAL DISSOCIATION DUE TO MECHANICAL PROSTHETIC VALVE DYSFUNCTION", J HEART VALVE DIS; VOL.9, NO. 3, MAY 2000; (466-468). CASE REPORT OF A PT WHO, APPROX 4 MONTHS POST MED HALL MITRAL VALVE REPLACEMENT (27MM), PRESENTED WITH RECURRENT EPISODES OF SYNCOPE. ECHOCARDIOGRAPHY SHOWED THE VALVE TO BE OPENING EITHER INTERMITTENTLY OR LATE IN DISATOLE, IN BETWEEN PERIODS OF NORMAL OPENING. A FILAMENTOUS STRUCTURE OF ABOUT 12MM LENGTH WAS SEEN, ATTACHED TO THE VALVE RING PROJECTING INTO THE "LVOT". A DIAGNOSIS OF INTERMITTENT VALVE DYSFUNCTION DUE TO MECHANICAL OBSTRUCTION WAS MADE. PT WAS ADMITTED FOR RE-OP AND PLACED UNDER STRICT CARDIAC MONITORING. FROM 5TH DAY ONWARD, PT BECAME ASYMPTOMATIC SPONTANEOUSLY. REPEAT ECHO SHOWED THE DISSAPPEARANCE OF THE FILAMENTOUS STRUCTURE AND NORMALIZATION OF VALVE FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC HALL PROSTHETIC HEART VALVE MECHANICAL HEART VALVE LWQ MEDTRONIC HEART VALVES, INC. M7700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention