BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE Y-90 (8 GBQ) CN CLINICAL

    MDR report key: 20363936 · Received October 3, 2024

    Report

    Report Number
    2124215-2024-61882
    Event Type
    Injury
    Date Received
    October 3, 2024
    Date of Event
    July 21, 2024
    Report Date
    October 3, 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

    A2 - AGE AT TIME OF EVENT: THE SUBJECT WAS 43 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. D3 & G1 - MANUFACTURER ADDRESS 1: (B)(6). D3 & G1 - MANUFACTURER ZIP/POSTAL CODE: (B)(6).

    Description of Event or Problem · 0

    MANDARIN CLINICAL STUDY IT WAS REPORTED THAT AS A RESULT OF THERASPHERE ADMINISTRATION, THE SUBJECT DEVELOPED AN INTESTINAL OBSTRUCTION AND WAS TREATED WITH PRESCRIPTION MEDICATION. ON (B)(6) 2024, THE SUBJECT WAS RANDOMIZED IN THE THERASPHERE ARM OF THE MANDARIN STUDY. TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2024. 99MTC-MAA ANGIOGRAM WAS PERFORMED, AND TARGET VOLUME WAS 673.4 CM3. THREE VIALS OF THERASPHERE WERE ADMINISTERED. 7.92 GBQ WAS ADMINISTERED THROUGH VIAL 1 (LOT # 2499330), 3.69 GBQ WAS ADMINISTERED THROUGH VIAL 2 (LOT # 2499324), AND 9.92 GBQ WAS ADMINISTERED THROUGH VIAL 3 (LOT # 2499328). A TOTAL OF 21.53 GBQ WAS ADMINISTERED. TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS REPORTED AS 0.089 GBQ, THERASPHERE DELIVERY TO PERFUSED LIVER TISSUE WAS 117 GY, AND DOSE TO PERFUSED TARGET TUMOR TISSUE WAS 234 GY. ON (B)(6) 2024, THREE DAYS POST INDEX PROCEDURE, THE SUBJECT EXPERIENCED VENTOSITY (FLATULENCE) AND ASTRICTION (INTESTINAL OBSTRUCTION). NO CORRECTIVE ACTION WAS TAKEN TO TREAT THE VENTOSITY. ASTRICTION WAS TREATED MEDICALLY USING A GLYCERIN ENEMA AND LACTULOSE ORAL SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442677 THERASPHERE Y-90 (8 GBQ) CN CLINICAL MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED 2361-01 2499330

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Required Intervention