BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIR-SPHERES MICROSPHERES

    MDR report key: 8101617 · Received November 26, 2018

    Report

    Report Number
    9710358-2018-00004
    Event Type
    Death
    Date Received
    November 26, 2018
    Date of Event
    July 25, 2018
    Report Date
    July 27, 2018
    Manufacturer
    SIRTEX MEDICAL LIMITED
    Product Code
    NAW
    PMA / PMN Number
    P990065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT DIED WITHIN 48 HOURS OF THE PROCEDURE. IN THE MIDDLE OF THE PROCEDURE THE PATIENT WAS EXPERIENCING CHEST PAIN AND THEY BROUGHT IN AN EKG AND PROCEEDED WITH THE ADMINISTRATION OF SIR-SPHERES. IMMEDIATELY FOLLOWING THE PROCEDURE A RAPID RESPONSE TEAM WAS DEPLOYED TO IR. I COULD CLEARLY TELL UNDER X-RAY THAT THE PATIENT HAD PRIOR OPEN HEART SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943500 SIR-SPHERES MICROSPHERES YTTRIUM 90 RESIN MICROSPHERES NAW SIRTEX MEDICAL LIMITED SIR-Y001

    Patients

    Seq Age Sex Outcome Treatment
    1 Death