BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y-90 THERASPHERE

    MDR report key: 17497423 · Received August 10, 2023

    Report

    Report Number
    2124215-2023-42172
    Event Type
    Injury
    Date Received
    August 10, 2023
    Date of Event
    May 19, 2023
    Report Date
    August 10, 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

    A1: PATIENT IDENTIFIER: (B)(6). A2: AGE AT TIME OF EVENT: THE PATIENT WAS 62 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.

    Description of Event or Problem · 0

    (B)(4) PROACTIF. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ASCITES AS A RESULT OF LIVER FUNCTION DETERIORATION 38 DAYS POST INDEX PROCEDURE. ON (B)(6) 2023, THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND SELECTIVE THERASPHERE TREATMENT WAS PERFORMED ON THE SAME DAY. THE CATHETER WAS POSITIONED IN THE RIGHT HEPATIC ARTERY (IRRESPECTIVE OF ORIGIN) (SEGMENTS V/VI/VII/VIII); 2.67 GBQ OF THERASPHERE WAS ADMINISTERED TO THE SELECTIVE LIVER THROUGH VIAL 1. POST DOSIMETRY RESULTS WERE NOT DETERMINED. ON (B)(6) 2023, 38 DAYS POST DURING INDEX PROCEDURE, THE SUBJECT EXPERIENCED DETERIORATION IN GENERAL HEALTH STATUS. ON (B)(6) 2023, THE SUBJECT CAME FOR ADDITIONAL FOLLOW UP VISIT AND WAS ADMITTED TO THE HOSPITAL FOR FURTHER TREATMENT AND EVALUATION. ON THE SAME DAY, ECOG PERFORMANCE SCORE AND ENCEPHALOPATHY SCALE WAS 0. ADDITIONALLY, ASCITES EVALUATION RESULT WAS 2, THE CHILD-PUGH SCORE WAS ASSESSED AS C10 AND BCLC CLASSIFICATION WAS A. DURING HOSPITALIZATION, THE SUBJECT WAS DIAGNOSED WITH LIVER FUNCTION DETERIORATION WHICH WAS PROBABLY DUE TO RADIO-EMBOLIZATION. ASCITES PUNCTURE WAS DONE AS A CORRECTIVE ACTION TO TREAT THE EVENT. ADDITIONALLY, SUBJECT WAS TREATED WITH CONCOMITANT MEDICATION. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797577 Y-90 THERASPHERE MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention