BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIR-SPHERES MICROSPHERES

    MDR report key: 16875496 · Received May 5, 2023

    Report

    Report Number
    9710358-2023-00002
    Event Type
    Death
    Date Received
    May 5, 2023
    Date of Event
    February 8, 2023
    Report Date
    May 4, 2023
    Manufacturer
    SIRTEX MEDICAL PTY LIMITED
    Product Code
    NAW
    UDI-DI
    M425SIRY0010
    PMA / PMN Number
    P990065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE TREATING PHYSICIAN DOES NOT BELIEVE THAT IT WAS SIR-SPHERES THAT CAUSED THE DEATH. SIRTEX CONDUCTED A REVIEW OF BATCH RB006 AND IT WAS FOUND TO BE A VERY TYPICAL BATCH; ALL ACTIVITY MEASUREMENTS AND QC TEST RESULTS WERE TYPICAL/ACCEPTABLE AND NO NON-CONFORMANCES WERE RAISED.

    Description of Event or Problem · 0

    SIRTEX'S SALES REPRESENTATIVE SPOKE WITH DR. CHO ON FRIDAY, APRIL 7 REGARDING AN ADVERSE EVENT THAT OCCURRED WITH A PATIENT THAT WAS TREATED ON (B)(6) 2023. PATIENT WAS PRESCRIBED 3.663 GBQ'S TO SEGMENT 5 OF THE RIGHT LOBE, TUMOR VOLUME WAS 16CC'S. PATIENT DEVELOPED ABDOMINAL PAIN POST TREATMENT WHICH PROGRESSED TO FURTHER COMPLICATIONS AFTER THE TREATMENT. PATIENT DIED 5-6 WEEKS LATER FROM SEPSIS WHICH ORIGINATED IN THE ANTERIOR PORTION OF THE RIGHT LOBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2213439 SIR-SPHERES MICROSPHERES Y90 RESIN MICROSPHERES NAW SIRTEX MEDICAL PTY LIMITED SIR-Y001 RB006 M425SIRY0010

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death