BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE Y-90 (10.5 GBQ) CN CLINICAL

    MDR report key: 13334071 · Received January 24, 2022

    Report

    Report Number
    2134265-2022-00442
    Event Type
    Injury
    Date Received
    January 24, 2022
    Date of Event
    September 26, 2021
    Report Date
    August 1, 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

    AGE AT TIME OF EVENT: (B)(6) AT THE TIME OF STUDY ENROLLMENT.

    Additional Manufacturer Narrative · 0

    A2: AGE AT TIME OF EVENT: 45 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. D3: MANUFACTURER ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK. G1: MFR SITE ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK. G1: MFR SITE ZIP/POST CODE: GU9 8QL.

    Additional Manufacturer Narrative · 0

    A2: AGE AT TIME OF EVENT: 45 YEARS OLD AT THE TIME OF STUDY ENROLLMENT. D3: MANUFACTURER ADDRESS 1: (B)(6). G1: MFR SITE ADDRESS 1: (B)(6). G1: MFR SITE ZIP/POST CODE: (B)(6).

    Description of Event or Problem · 0

    MANDARIN STUDY. IT WAS REPORTED THAT THE SUBJECT EXPERIENCED PLEURAL EFFUSION, REQUIRING INTERVENTION. ON (B)(6) 2021, THE SUBJECT WAS ENROLLED INTO MANDARIN STUDY. PLANNED TREATMENT TYPE WAS UNI-LOBAR TREATMENT. TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. TOTAL CALIBRATED ACTIVITY PRIOR TO INFUSION WAS 3.12 GBQ AND CALCULATED DOSE TO PERFUSED TARGET LIVER TISSUE WAS 213.49 GY. ON (B)(6) 2021, 2 DAYS POST THERASPHERE PROCEDURE, THE SUBJECT EXPERIENCED LOSS OF APPETITE AND WAS NOTED WITH FEVER. BOTH EVENTS WERE CONSIDERED MILD. NO ACTION WAS TAKEN TO TREAT THE EVENTS. THE EVENTS WERE CONSIDERED RESOLVED WITHIN 1-2 DAYS. ON (B)(6) 2021, 21 DAYS POST THERASPHERE PROCEDURE, THE SUBJECT EXPERIENCED LOSS OF APPETITE. NO ACTION WAS TAKEN TO TREAT THE EVENT. THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2021. ON (B)(6) 2021, 36 DAYS POST THERASPHERE PROCEDURE, THE SUBJECT EXPERIENCED PLEURAL EFFUSION. PLEURAL PUNCTURE WAS PERFORMED AS AN INTERVENTIONAL PROCEDURE. ON (B)(6) 2021 THE EVENT WAS CONSIDERED RESOLVED.

    Description of Event or Problem · 0

    MANDARIN STUDY: IT WAS REPORTED THAT THE SUBJECT EXPERIENCED PLEURAL EFFUSION, REQUIRING INTERVENTION. ON (B)(6) 2021, THE SUBJECT WAS ENROLLED INTO MANDARIN STUDY. PLANNED TREATMENT TYPE WAS UNI-LOBAR TREATMENT. TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. TOTAL CALIBRATED ACTIVITY PRIOR TO INFUSION WAS 3.12 GBQ AND CALCULATED DOSE TO PERFUSED TARGET LIVER TISSUE WAS 213.49 GY. ON (B)(6) 2021, 2 DAYS POST THERASPHERE PROCEDURE, THE SUBJECT EXPERIENCED LOSS OF APPETITE AND WAS NOTED WITH FEVER. BOTH EVENTS WERE CONSIDERED MILD. NO ACTION WAS TAKEN TO TREAT THE EVENTS. THE EVENTS WERE CONSIDERED RESOLVED WITHIN 1-2 DAYS. ON (B)(6) 2021, 21 DAYS POST THERASPHERE PROCEDURE, THE SUBJECT EXPERIENCED LOSS OF APPETITE. NO ACTION WAS TAKEN TO TREAT THE EVENT. THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2021. ON (B)(6) 2021, 36 DAYS POST THERASPHERE PROCEDURE, THE SUBJECT EXPERIENCED PLEURAL EFFUSION. PLEURAL PUNCTURE WAS PERFORMED AS AN INTERVENTIONAL PROCEDURE. ON 16-NOV-2021 THE EVENT WAS CONSIDERED RESOLVED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2021, 99MTC-MAA ANGIOGRAM WAS PERFORMED, AND TUMOR VOLUME/TARGET VOLUME WAS 552 CM3. 10.5 GBQ WAS ADMINISTERED THROUGH VIAL 1.

    Description of Event or Problem · 0

    MANDARIN STUDY: IT WAS REPORTED THAT THE SUBJECT EXPERIENCED PLEURAL EFFUSION, REQUIRING INTERVENTION. ON (B)(6) 2021, THE SUBJECT WAS ENROLLED INTO MANDARIN STUDY. PLANNED TREATMENT TYPE WAS UNI-LOBAR TREATMENT. TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. TOTAL CALIBRATED ACTIVITY PRIOR TO INFUSION WAS 3.12 GBQ AND CALCULATED DOSE TO PERFUSED TARGET LIVER TISSUE WAS 213.49 GY. ON (B)(6) 2021, 2 DAYS POST THERASPHERE PROCEDURE, THE SUBJECT EXPERIENCED LOSS OF APPETITE AND WAS NOTED WITH FEVER. BOTH EVENTS WERE CONSIDERED MILD. NO ACTION WAS TAKEN TO TREAT THE EVENTS. THE EVENTS WERE CONSIDERED RESOLVED WITHIN 1-2 DAYS. ON (B)(6) 2021, 21 DAYS POST THERASPHERE PROCEDURE, THE SUBJECT EXPERIENCED LOSS OF APPETITE. NO ACTION WAS TAKEN TO TREAT THE EVENT. THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2021. ON (B)(6) 2021, 36 DAYS POST THERASPHERE PROCEDURE, THE SUBJECT EXPERIENCED PLEURAL EFFUSION. PLEURAL PUNCTURE WAS PERFORMED AS AN INTERVENTIONAL PROCEDURE. ON (B)(6) 2021 THE EVENT WAS CONSIDERED RESOLVED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2021, 99MTC-MAA ANGIOGRAM WAS PERFORMED, AND TUMOR VOLUME/TARGET VOLUME WAS 552 CM3. 10.5 GBQ WAS ADMINISTERED THROUGH VIAL 1. IT WAS FURTHER REPORTED THAT MEDICATION WAS ADMINISTERED AS A CORRECTIVE ACTION TO TREAT THE FEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834743 THERASPHERE Y-90 (10.5 GBQ) CN CLINICAL MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED 2361-01 2199439

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention