BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y-90 THERASPHERE

    MDR report key: 15904364 · Received December 2, 2022

    Report

    Report Number
    2124215-2022-50110
    Event Type
    Injury
    Date Received
    December 2, 2022
    Date of Event
    February 2, 2022
    Report Date
    December 2, 2022
    Manufacturer
    BIOCOMPATIBLES UK LIMITED
    Product Code
    NAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER ADDRESS 1: (B)(4).

    Description of Event or Problem · 0

    PROACTIF CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT HAD HEPATITIS POST THERASPHERE PROCEDURE. STANDARD, SINGLE COMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS TREATMENT DOSE. PRE-TREATMENT IMAGING DOCUMENTED A STRONG UPTAKE OF TC-MAA ON TUMOR. ON (B)(6) 2021, THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. TYPE OF THERASPHERE INFUSION WAS SELECTIVE; 1.070 GBQ WAS ADMINISTERED SELECTIVELY THROUGH CAUDATE-SPIEGEL LOBE (SEGMENT I) THROUGH VIAL 1. POST-TREATMENT DOSIMETRY DOCUMENTED A STRONG UPDATE OF THE DELIVERED DOSE. THE DELIVERED DOSE ABSORBED TO TOTAL PERFUSED LIVER AND TOTAL PERFUSED TUMOR WAS 921 GY, RESPECTIVELY. ON (B)(6) 2022, 50 DAYS POST INDEX PROCEDURE, AN EVENT OF HEPATIC CYTOLYSIS PREDOMINANTLY ON AST WAS REPORTED. THE ACTION TAKEN WAS TO STOP CHEMOTHERAPY BY (B)(6). IN (B)(6) 2022, THE EVENT WAS CONSIDERED RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347161 Y-90 THERASPHERE MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other