BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y-90 THERASPHERE

    MDR report key: 20019177 · Received August 21, 2024

    Report

    Report Number
    2124215-2024-51046
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    December 23, 2022
    Report Date
    August 20, 2024
    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) 1938. D3: MANUFACTURER ADDRESS 1: CHAPMAN HOUSE, FARNHAM BUS PARK. D3: MANUFACTURER ZIP/POSTAL CODE: GU9 8QL. 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 ANASARCA WITH OEDEMATOASCITIC DECOMPENSATION AND HEMORRHAGIC SHOCK OCCURRED. STANDARD, SINGLE COMPARTMENT DOSIMETRY WAS PERFORMED TO ASSESS TREATMENT DOSE. PRE-TREATMENT MACRO AGGREGATED ALBUMIN (MAA) DOSIMETRY DOCUMENTED, DOSE TO TOTAL PERFUSED LIVER AS 199.2 GY. DOSE TO TOTAL PERFUSED TUMOR WAS 359.4 GY. ON (B)(6) 2022, 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. THERASPHERE ACTIVITY WAS ADMINISTERED TO THE SELECTIVE LIVER THROUGH VIAL 1. ON (B)(6) 2022, 37 DAYS POST INDEX PROCEDURE COMPUTED TOMOGRAPHY (CT) SCAN REVEALED DECOMPENSATION OF THE LIVER DISEASE WITH INCREASED ASCITES. THE SUBJECT WAS NOTED WITH EDEMA OF LOWER LIMBS WAS ALSO DIAGNOSED ON THE SAME DAY. ON (B)(6) 2022, 42 DAYS POST INDEX PROCEDURE, SUBJECT PRESENTED THE FIRST EPISODE OF HEMATEMESIS. ON (B)(6) 2022, ANOTHER THREE EPISODES OF HEMATEMESIS WAS NOTED. THEREFORE, SUBJECT WAS HOSPITALIZED EMERGENTLY ON THE SAME DAY. TREATMENT WITH FILLING, PANTAPRAZOLE AND SANDOSTATINE WAS INITIATED FOR HEMORRHAGIC SHOCK. UPPER GASTROINTESTINAL (GI) ENDOSCOPY REVEALED TWO LARGE CORDS OF ESOPHAGEAL VARICES, WITH RED SIGN, LIGATED WITH 5 RUBBER BANDS. ADDITIONALLY, ENDOSCOPY ALSO REVEALED DUODENAL ANGIODYSPLASIAS WITH TRACES OF FRESH BLOOD, ELECTROCOAGULATED WITH GOLDPROBE. SUBJECT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND 2 UNITS OF PACKED RED BLOOD CELLS (PRBC) AND 2 UNITS OF FRESH FROZEN PLASMA (FFP) WERE TRANSFUSED. ON (B)(6) 2023 THE EVENT OF HEMORRHAGIC SHOCK WAS CONSIDERED RESOLVED. NO RECURRENCE OF BLEEDING WAS NOTED DURING HOSPITALIZATION. HENCE, SANDOSTATINE WAS DISCONTINUED ON (B)(6) 2023. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2023, 64 DAYS POST INDEX PROCEDURE, DUE TO THE CLINICAL WORSENING OF THE SUBJECT'S HEALTH, THE SUBJECT WAS ADMITTED TO THE HOSPITAL FOR FURTHER TREATMENT AND EVALUATION. DURING HOSPITALIZATION, SUBJECT WAS DIAGNOSED WITH POST RADIOEMBOLIZATION ANASARCA. SUBJECT WAS TREATED WITH CONCOMITANT MEDICATION. SIGNIFICANT DIURETIC AGENTS LIKE LASILIX AND ALDACTONE OF 150 MG WAS GIVEN TO TREAT THE EVENT. SUBJECT LOST 29 KGS, WITH THE TREATMENT USING DIURETICS. HENCE, TREATMENT WITH DIURETICS WERE GRADUALLY REDUCED (ALDACTONE CONCENTRATION WAS MAINTAINED). ON (B)(6) 2023, ANASARCA WITH OEDEMATOASCITIC DECOMPENSATION WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY. ON (B)(6) 2023, THE SYMPTOMS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300145 Y-90 THERASPHERE MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Life Threatening| R| H