BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE Y-90 (5 GBQ)

    MDR report key: 16250169 · Received January 26, 2023

    Report

    Report Number
    2124215-2023-00197
    Event Type
    Injury
    Date Received
    January 26, 2023
    Date of Event
    December 7, 2022
    Report Date
    January 26, 2023
    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 THIS PATIENT WAS TREATED FOR ASCITES AND ELEVATED CHILD-PUGH SCORE C10. ON (B)(6) 2022, THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. THE THERASPHERE INFUSION SITE WAS SELECTIVE; 4.744 GBQ WAS ADMINISTERED THROUGH RIGHT HEPATIC ARTERY (IRRESPECTIVE OF ORIGIN) (SEGMENTS V/VI/VII/VIII). POST-TREATMENT DOSIMETRY DOCUMENTED A STRONG UPTAKE OF Y90 ON TUMORS, DOSE TO PERFUSED LIVER WAS 104 GY AND DOSE TO PERFUSED TUMOR WAS 116 GY. UPON AN ADDITIONAL FOLLOW-UP VISIT ON 07-DEC-2022 (70 DAYS POST-INDEX PROCEDURE), THE SUBJECT HAD DEVELOPED ASCITES AND LIVER DETERIORATION ALONG WITH AN ELEVATED CHILD-PUGH SCORE C10 (GRADE 3). IN RESPONSE TO THIS EVENT, THE ASCITES WAS TREATED MEDICALLY. THE ELEVATED CHILD-PUGH SCORE WAS ALSO TREATED MEDICALLY AS WELL AS SURGERY/INTERVENTIONAL RADIOLOGY PROCEDURE WAS ALSO PERFORMED. IT WAS NOTED THAT THE ELEVATED CHILD-PUGH SCORE WAS ALSO RELATED TO TUMOR PROGRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203508 THERASPHERE Y-90 (5 GBQ) MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention