BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y-90 THERASPHERE

    MDR report key: 21895742 · Received April 23, 2025

    Report

    Report Number
    2124215-2025-25920
    Event Type
    Injury
    Date Received
    April 23, 2025
    Date of Event
    January 5, 2024
    Report Date
    April 23, 2025
    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

    ONLY THE LOT NUMBER WAS REPORTED BY THE CLINICAL STUDY; THUS, THE UDI AND PRODUCT SPECIFIC INFORMATION IS UNKNOWN. 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 EXPERIENCED POST-EMBOLIZATION SYMPTOMS THAT WERE TREATED WITH MEDICATION. ON (B)(6) 2023, THE SUBJECT WAS RANDOMIZED (THERASPHERE ARM) IN A CLINICAL STUDY (MAIN PHASE). THE PLANNED TREATMENT TYPE WAS SELECTIVE, AND TREATMENT WITH THERASPHERE WAS PERFORMED ON (B)(6) 2024. THE 99MTC-MAA ANGIOGRAM WAS PERFORMED AND TARGET VOLUME WAS 156.7 CM3, AND 3.13 GBQ AND 3.02 GBQ WERE ADMINISTERED THROUGH TWO VIALS. A TOTAL 6.14 GBQ WAS ADMINISTERED DURING THE INDEX PROCEDURE. THE TOTAL ACTIVITY OF THERASPHERE DELIVERY TO LUNG WAS REPORTED AS 3.1 GBQ, THERASPHERE DELIVERY TO PERFUSED LIVER TISSUE WAS 1.93 GBQ, AND TOTAL RADIATION DOSE TO LUNGS 3.1 GY AND RADIATION DOSE TO PERFUSED LIVER WAS 0 GY. ON (B)(6) 2024, ON THE SAME DAY OF INDEX PROCEDURE, THE SUBJECT EXPERIENCED NAUSEA AND ABDOMINAL PAIN DUE TO POST-INTERVENTIONAL EMBOLIZATION SYNDROME THAT WAS TREATED WITH MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680377 Y-90 THERASPHERE MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED 2399613

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention