BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y-90 THERASPHERE

    MDR report key: 17182059 · Received June 22, 2023

    Report

    Report Number
    2124215-2023-31992
    Event Type
    Injury
    Date Received
    June 22, 2023
    Date of Event
    June 25, 2020
    Report Date
    June 22, 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

    A2: DATE OF BIRTH: (B)(6) 1964. G1: MFR SITE ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK. G1: MFR SITE ZIP/POST CODE: GU9 8QL.

    Description of Event or Problem · 0

    PROACTIF CLINICAL STUDY: IT WAS REPORTED THAT THE PATIENT EXPERIENCED LIVER DYSFUNCTION. STANDARD, SINGLE COMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS TREATMENT DOSE. PRE-TREATMENT MAA DOSIMETRY DOCUMENTED DOSE TO TOTAL PERFUSED LIVER AS 188.9 GY. DOSE TO TOTAL PERFUSED TUMOR WAS NOT DETERMINED. ON (B)(6) 2020, 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. THE CATHETER WAS POSITIONED IN THE RIGHT HEPATIC ARTERY (IRRESPECTIVE OF ORIGIN) (SEGMENTS V/VI/VII/VIII); 1.64 GBQ OF THERASPHERE WAS ADMINISTERED TO THE SELECTIVE LIVER THROUGH VIAL 1. POST DOSIMETRY RESULTS WERE NOT DETERMINED. ON (B)(6) 2020, 49 DAYS POST INDEX PROCEDURE, SUBJECT EXPERIENCED DETERIORATION IN HEALTH. ON THE SAME DAY, THE SUBJECT WAS HOSPITALIZED FOR FURTHER TREATMENT AND EVALUATION. DURING THE COURSE OF HOSPITALIZATION, THE SUBJECT WAS DIAGNOSED WITH AN ELEVATED CHILD-PUGH SCORE OF C11. ON THE SAME DAY, ECOG PERFORMANCE SCORE WAS 0, ASCITES ASSESSMENT SCORE WAS 2, BCLC WAS ASSESSED AS D AND CHILD-PUGH SCORE WAS GREATER THAN C10. CONCOMITANT MEDICATION WAS ADMINISTRATED TO TREAT THE EVENT. THE TREATMENT WITH THERASPHERE DECOMPENSATED THE HEPATIC FUNCTION. ON (B)(6) 2020, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. OF NOTE, ON (B)(6) 2020, 77 DAYS POST INDEX PROCEDURE, THE SUBJECT EXPERIENCED SEPTIC SHOCK OF UNKNOWN ORIGIN. CONCOMITANT MEDICATION WAS ADMINISTRATED TO TREAT THE EVENT. ADDITIONALLY, SUBJECT WAS GIVEN END OF LIFE SUPPORT AND COMFORT CARE. ON (B)(6) 2020, 83 DAYS POST INDEX PROCEDURE, THE SUBJECT PASSED AWAY. THE PHYSICIAN NOTED THE SEPTIC SHOCK AND DEATH TO BE NOT RELATED TO THE ADMINISTRATION PROCEDURE AND NOT RELATED TO THE THERASPHERE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062452 Y-90 THERASPHERE MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Hospitalization