BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y-90 THERASPHERE (3 GBQ) CANADA COMM

    MDR report key: 12626944 · Received October 13, 2021

    Report

    Report Number
    2134265-2021-12712
    Event Type
    Injury
    Date Received
    October 13, 2021
    Date of Event
    August 22, 2021
    Report Date
    October 13, 2021
    Product Code
    NAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT PANCREATITIS 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. TYPE OF THERASPHERE INFUSION WAS IN THE RIGHT ANTERIOR SECTOR (SEGMENTS V/VIII). 1.03 GBQ WAS ADMINISTERED TO THE LIVER (ULTRA-SELECTIVE) THROUGH VIAL 1 AND 1.06 GBQ WAS ADMINISTERED TO THE LIVER (ULTRA-SELECTIVE) THROUGH VIAL 2. TOTAL DOSE ADMINISTERED TO THE LIVER WAS 2.09 GBQ. IN (B)(6) 2021, 30 DAYS POST INDEX-PROCEDURE, THE SUBJECT WAS HOSPITALIZED FOR ABDOMINAL PAIN WITH INCREASED JAUNDICE. THE COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED FOR FURTHER EVALUATION; INDICATED ACUTE PANCREATITIS. CHOLECYSTITIS AND RADIATION OR ISCHEMIC CHOLANGITIS WAS NOTED, SUSPECTED TO BE DUE TO EMBOLIZATION OF THE BILIARY ARTERIES FOLLOWING RADIO EMBOLIZATION. THE EVENT WAS TREATED MEDICALLY. SUBJECT WAS MADE TO FAST, WAS HYDRATED AND TREATED WITH ACUPAN EPS. THE LIVER FUNCTION WAS NOTED TO IMPROVE SPONTANEOUSLY AND SUBJECT NO LONGER COMPLAINED OF PAIN. SIX DAYS LATER, THE SUBJECT WAS DISCHARGED AND THE EVENT WAS CONSIDERED RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525712 Y-90 THERASPHERE (3 GBQ) CANADA COMM MICROSPHERES RADIONUCLIDE NAW

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention