BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMBOSPHERE

    MDR report key: 309267 · Received December 11, 2000

    Report

    Report Number
    66641-2000-00003
    Event Type
    Death
    Date Received
    December 11, 2000
    Date of Event
    November 10, 2000
    Report Date
    December 8, 2000
    Manufacturer
    BIOSPHERE MEDICAL S.A.
    Product Code
    HCG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A SPLENIC EMBOLIZATION WAS PERFORMED ON A PT WITH A DIAGNOSIS OF SPLENOMEGALY. THE SPLEEN WAS UNUSUALLY LARGE AND THE PT HAD OTHER SYMPTOMS INCLUDING HEMOLYTIC ANEMIA AND THROMBOCYTOPENIA. 4CC OF 500-700 MICRONS EMBOSPHERES FOLLOWED BY 2CC OF 700-900 MICRONS EMBOSPHERES WERE DELIVERED. THERE WAS SUFFICIENT BLOOD FLOW TO THE SPLEEN SO IT WOULD NOT COMPLETELY INFARCT. ANGIOGRAPHICALLY, THE OUTCOME WAS SATISFACTORY. THE PT WAS DOING WELL BY MORNING. THE PHYSICIAN SAW THE PT AND RELEASED THE PT. WHILE PT WAS PREPARING TO LEAVE THE HOSPITAL, RESPIRATORY DEPRESSION BEGAN AND THE PT WAS INTUBATED. THE PT WAS STABLE THROUGH THE NIGHT AND EXTUBATED THEMSELVES. THE PT DID NOT REQUIRE INTUBATION AGAIN. THE PT EXPIRED A FEW DAYS LATER OF UNKNOWN CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSPHERE ARTIFICIAL EMBOLISM DEVICE HCG BIOSPHERE MEDICAL S.A. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death