BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMBOSPHERE MICROSPHERES

    MDR report key: 420377 · Received October 2, 2002

    Report

    Report Number
    1226551-2002-00009
    Event Type
    Death
    Date Received
    October 2, 2002
    Date of Event
    September 4, 2002
    Report Date
    October 1, 2002
    Manufacturer
    BIOSPHERE MEDICAL, SA, BAT A-PARC DES NATIONS
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS EMBOLIZED TO TREAT A RECURRENT LEFT PARIETAL MENINGIOMA/HEMANGIOPERICYTOMA. THE PT EXPIRED DUE TO HEMORRHAGING AFTER UNDERGOING THE EMBOLIZATION PROCEDURE. THE TUMOR WAS FED BY TWO LARGE BRANCHES OF THE LEFT MIDDLE MENINGEAL ARTERY. THREE VIALS OF EMBOSPHERE MICROSPHERES WERE USED (100-300 MICRONS), THEN TWO VIALS OF PRODUCT (300-500 MICRONS) WERE INJECTED SLOWLY INTO THE FEEDING ARTERY. AFTER THAT DIVISION WAS EMBOLIZED, THE FINAL MICROCATHETER INJECTION SHOWED CONTRAST POOLING AT THE PERIPHERY OF THE TUMOR, PROBABLY EXTRAVASATION. THE PT COMPLAINED OF A SEVERE HEADACHE, BECAME BRADYCARDIC AND HYPERTENSIVE, THEN UNRESPONSIVE. A LEFT CAROTID ANGIOGRAM SHOWED SIGNIFICANTLY INCREASED MASS EFFECT IN THE LEFT HEMISPHERE. PT'S HEPARIN ANTICOAGULATION WAS REVERSED WITH PROTAMINE. PT'S LEFT PUPIL DILATED AND THEY LOST BRAINSTEM REFLEXES. A CRANIECTOMY WAS PERFORMED BUT PT DIED LATER THAT NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSPHERE MICROSPHERES ARTIFICIAL EMBOLIC AGENT HCG BIOSPHERE MEDICAL, SA, BAT A-PARC DES NATIONS 300-500 MICRONS, 100-300 MICRONS MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death