BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE Y-90 (3.5 GBQ) CN CLINICAL

    MDR report key: 20506822 · Received October 22, 2024

    Report

    Report Number
    2124215-2024-65789
    Event Type
    Injury
    Date Received
    October 22, 2024
    Date of Event
    March 14, 2024
    Report Date
    October 22, 2024
    Manufacturer
    BIOCOMPATIBLES UK LIMITED
    Product Code
    NAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D3, MANUFACTURER ZIP/POSTAL: GU9 8QL. G1, MFR SITE ZIP/POST CODE: GU9 8QL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS TREATED MEDICALLY FOR PAIN. ON (B)(6) 2024, THE SUBJECT WAS RANDOMIZED TO THERASPHERE ARM IN THE MANDARIN STUDY (MAIN PHASE). PLANNED TREATMENT TYPE WAS UNI-LOBAR TREATMENT. TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2024. MAPPING 99MTC-MAA ANGIOGRAM WAS PERFORMED, AND TARGET VOLUME WAS 48 CM3. TREATMENT WAS PERFORMED ADMINISTERING 3.6 GBQ THROUGH 1 VIAL AND 6.68 GBQ THROUGH 2ND VIAL. THE TOTAL DOSE ADMINISTERED WAS 10.28 GBQ. TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS 0.09 GBQ AND 825 GY. THE DOSE WAS PERFUSED TO TARGET TUMOR TISSUE, AND 99.8 GY PERFUSED TO NORMAL LIVER TISSUE. ON (B)(6) 2024, ON THE SAME DAY OF INDEX PROCEDURE, SUBJECT HAD EXPERIENCED MILD ABDOMINAL PAIN AND NAUSEA, AND AS A RESULT, FLURBIPROFEN AXETIL INJECTION WAS ADMINISTERED FOR THE ABDOMINAL PAIN. NO CORRECTIVE ACTION WAS TAKEN RELATED TO NAUSEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946920 THERASPHERE Y-90 (3.5 GBQ) CN CLINICAL MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED 2361-01 2499114

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention