BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE Y-90 (8 GBQ) CN CLINICAL

    MDR report key: 19798927 · Received July 22, 2024

    Report

    Report Number
    2124215-2024-44538
    Event Type
    Injury
    Date Received
    July 22, 2024
    Date of Event
    June 21, 2024
    Report Date
    November 12, 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 ADDRESS 1:(B)(6). D3: MANUFACTURER ZIP/POSTAL CODE: (B)(6). G1: MFR SITE ADDRESS 1:(B)(6) G1: MFR SITE ZIP/POST CODE: (B)(6).

    Additional Manufacturer Narrative · 0

    D3: MANUFACTURER ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK, D3: MANUFACTURER ZIP/POSTAL CODE: GU9 8QL, G1: MFR SITE ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK, G1: MFR SITE ZIP/POST CODE: GU9 8QL.

    Description of Event or Problem · 0

    MANDARIN CLINICAL STUDY IT WAS REPORTED THAT THE SUBJECT HAD ABDOMINAL PAIN REQUIRING PRESCRIPTION MEDICATION. ON (B)(6) 2024, THE SUBJECT WAS THE SUBJECT WAS RANDOMIZED (THERASPHERE ARM) IN THE MANDARIN STUDY (MAIN PHASE). PLANNED TREATMENT TYPE WAS SELECTIVE TREATMENT. TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2024. 99MTC-MACROAGGREGATED ALBUMIN (MAA) ANGIOGRAM WAS PERFORMED, AND TARGET VOLUME WAS 190 CM3. 8.02 GBQ WAS ADMINISTERED THROUGH 1 VIAL. TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS 0.129 GBQ. THERASPHERE DELIVERY TO PERFUSED LIVER TISSUE WAS 2.35 GBQ. RADIATION DOSE TO PERFUSED LIVER TISSUE WAS 600 GY AND TOTAL RADIATION DOSE TO LUNGS WAS 6.4 GY. ON (B)(6) 2024, ON THE SAME DAY OF INDEX PROCEDURE, THE SUBJECT EXPERIENCED ABDOMINAL PAIN AND NAUSEA. FLURBIPROFEN AXETIL INJECTION, COMPOUND CODEINE PHOSPHATE, AND IBUPROFEN SUSTAINED RELEASE TABLETS WERE ADMINISTERED AS A CORRECTIVE ACTION FOR THE ABDOMINAL PAIN. MEDICATION GIVEN OR REGIMEN WAS ADJUSTED TO TREAT THE EVENT OF NAUSEA.

    Description of Event or Problem · 0

    MANDARIN CLINICAL STUDY. IT WAS REPORTED THAT THE SUBJECT HAD ABDOMINAL PAIN REQUIRING PRESCRIPTION MEDICATION. ON (B)(6) 2024, THE SUBJECT WAS THE SUBJECT WAS RANDOMIZED (THERASPHERE ARM) IN THE MANDARIN STUDY (MAIN PHASE). PLANNED TREATMENT TYPE WAS SELECTIVE TREATMENT. TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2024. 99MTC-MACROAGGREGATED ALBUMIN (MAA) ANGIOGRAM WAS PERFORMED, AND TARGET VOLUME WAS 190 CM3. 8.02 GBQ WAS ADMINISTERED THROUGH 1 VIAL. TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS 0.129 GBQ. THERASPHERE DELIVERY TO PERFUSED LIVER TISSUE WAS 2.35 GBQ. RADIATION DOSE TO PERFUSED LIVER TISSUE WAS 600 GY AND TOTAL RADIATION DOSE TO LUNGS WAS 6.4 GY. ON (B)(6) 2024, ON THE SAME DAY OF INDEX PROCEDURE, THE SUBJECT EXPERIENCED ABDOMINAL PAIN AND NAUSEA. FLURBIPROFEN AXETIL INJECTION, COMPOUND CODEINE PHOSPHATE, AND IBUPROFEN SUSTAINED RELEASE TABLETS WERE ADMINISTERED AS A CORRECTIVE ACTION FOR THE ABDOMINAL PAIN. MEDICATION GIVEN OR REGIMEN WAS ADJUSTED TO TREAT THE EVENT OF NAUSEA. IT WAS FURTHER REPORTED THAT NO DRUGS WERE ADMINISTERED TO TREAT THE NAUSEA; HOWEVER, ELECTROSTATIC THERAPY WAS INDUCED TO ALLEVIATE THE NAUSEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2466670 THERASPHERE Y-90 (8 GBQ) CN CLINICAL MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED 2361-01 2499282

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention