BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y-90 THERASPHERE (3 GBQ) CANADA COMM

    MDR report key: 13015075 · Received December 15, 2021

    Report

    Report Number
    2134265-2021-15873
    Event Type
    Injury
    Date Received
    December 15, 2021
    Date of Event
    January 28, 2021
    Report Date
    February 10, 2022
    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

    B5 DESCRIBE EVENT OR PROBLEM AND H6 PATIENT CODES: UPDATED.

    Description of Event or Problem · 0

    PROACTIF STUDY . IT WAS REPORTED THAT AN INFECTION OCCURRED. IN (B)(6) 2021, THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. THE TYPE OF THERASPHERE INFUSION WAS IN THE PROPER HEPATIC ARTERY. 1.2 GBQ OF THERASPHERE WAS ADMINISTERED TO THE LIVER (SELECTIVE) THROUGH VIAL 1 AND 0.3 GBQ OF THERASPHERE WAS ADMINISTERED TO THE LIVER (SELECTIVE) THROUGH VIAL 2. THE TOTAL DOSE ADMINISTERED WAS 1.5 GBQ. TWO DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH INFECTION AND ACUTE RENAL FAILURE. THE SUBJECT HAD A BODY TEMPERATURE OF 39 DEGREES C AND WAS POSITIVE FOR K. PNEUMONIAE AND K. OXYTOCA. THE SUBJECT WAS TREATED MEDICALLY. FIVE DAYS POST INDEX PROCEDURE THE EVENTS WERE CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY. IT WAS FURTHER REPORTED THE SUBJECT WAS DIAGNOSED WITH BACTEREMIA. THE SUBJECT WAS HOSPITALIZED AND THE EVENTS WERE TREATED MEDICALLY AND OLIGURIA WAS ADMINISTERED WITH HYDRATION AND LASILIX..

    Description of Event or Problem · 0

    (B)(6) STUDY. IT WAS REPORTED THAT AN INFECTION OCCURRED. IN (B)(6) 2021, THE SUBJECT WAS ENROLLED INTO THE (B)(6) STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. THE TYPE OF THERASPHERE INFUSION WAS IN THE PROPER HEPATIC ARTERY. 1.2 GBQ OF THERASPHERE WAS ADMINISTERED TO THE LIVER (SELECTIVE) THROUGH VIAL 1 AND 0.3 GBQ OF THERASPHERE WAS ADMINISTERED TO THE LIVER (SELECTIVE) THROUGH VIAL 2. THE TOTAL DOSE ADMINISTERED WAS 1.5 GBQ. TWO DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH INFECTION AND ACUTE RENAL FAILURE. THE SUBJECT HAD A BODY TEMPERATURE OF 39 DEGREES CELSIUS AND WAS POSITIVE FOR K. PNEUMONIAE AND K. OXYTOCA. THE SUBJECT WAS TREATED MEDICALLY. FIVE DAYS POST INDEX PROCEDURE THE EVENTS WERE CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911613 Y-90 THERASPHERE (3 GBQ) CANADA COMM MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male Required Intervention