BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC HALL PROSTHETIC HEART VALVE

    MDR report key: 99586 · Received June 18, 1997

    Report

    Report Number
    6000026-1997-00015
    Event Type
    Injury
    Date Received
    June 18, 1997
    Report Date
    May 20, 1997
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTED IN JOURNAL ARTICLE: "THROMBOLYSIS FOR PROSTHETIC VALVE THROMBOSIS: INDICATIONS AND RESULTS", THE JOURNAL OF HEART VALVE DISEASE, MARCH 1997;6:212-218. THIS ARTICLE PROVIDED RESULTS ON THROMBOLYSIS FOR PROSTHETIC VALVE THROMBOSIS. BETWEEN JAN. 1991 AND JAN. 1994 THERE WERE 20 CASES OF PROTHETIC THROMBOSIS TREATED WITH THROMBOLYSIS USING RECOMBINANT TISSUE TYPE PLASMINOGEN ACTIVATOR (RE-PA). 2 FEMALE PATIENTS HAD MEDTRONIC HALL VALVES. THROMBOLYTIC THERAPY WAS SUCCESSFULL IN 19 OF THE 20 PATIENTS. ONE PATIENT WITH A SORIN VALVE UNDERWENT REOPERATION. CONCLUSION: THROMBOLYSIS THERAPY AS TREATMENT PROVED SATISFACTORY.

    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 58 YR Hospitalization| R