BEUDAMED
    FDA Adverse Event Death Summary report: N

    Y-90 THERASPHERE (3 GBQ) CANADA COMM

    MDR report key: 12814055 · Received November 15, 2021

    Report

    Report Number
    2134265-2021-14301
    Event Type
    Death
    Date Received
    November 15, 2021
    Date of Event
    October 1, 2021
    Report Date
    November 15, 2021
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    NAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: KUMAR, P., MHASKAR, R., BIBOK, A., KIM, R., ANAYA, D., FRAKES, J., HOFFE, S., EL-HADDAD, G., CHOI, J., & KIS, B. (2021). ABSTRACT NO. 160 UNRESECTABLE INTRAHEPATIC CHOLANGIOCARCINOMA TREATED WITH RADIATION SEGMENTECTOMY/LOBECTOMY USING Y90-LABELED GLASS MICROSPHERES. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 32(5), S71. HTTPS//DOI.ORG/10.1016/J.JVIR.2021.03.166. EVENT DATE: UNKNOWN, USE FIRST DAY MONTH BSC WAS MADE AWARE, 10/1/2021 IMPLANT DATE - (B)(6) 2009 AND (B)(6) 2019. DEATH DATE - (B)(6) 2009 AND (B)(6). 2019.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA ABSTRACT ARTICLE#160: "UNRESECTABLE INTRAHEPATIC CHOLANGIOCARCINOMA TREATED WITH RADIATION SEGMENTECTOMY/LOBECTOMY USING Y90-LABELED GLASS MICROSPHERES", PATIENTS DEATH OCCURRED. THE PURPOSE OF THE ARTICLE IS TO EVALUATE THE SAFETY AND EFFICACY OF RADIATION SEGMENTECTOMY/LOBECTOMY USING Y90-LABELED GLASS MICROSPHERES IN PATIENTS WITH UNRESECTABLE INTRAHEPATIC CHOLANGIOCARCINOMA (IHC). THIS IS A SINGLE-CENTER, RETROSPECTIVE STUDY INCLUDED 16 PATIENTS WITH IHC WHO RECEIVED RADIATION SEGMENTECTOMY OR LOBECTOMY TREATMENT USING Y90-LABELED GLASS MICROSPHERES BETWEEN MAY 2009 AND OCTOBER 2019. RADIATION SEGMENTECTOMY/LOBECTOMY WAS DEFINED AS AT LEAST 190 GY DOSE DELIVERED INTO THE TREATED LIVER VOLUME . PATIENTS WERE NOT EXCLUDED IF THEY HAD PRIOR LIVER-DIRECTED THERAPY OR CHEMOTHERAPY. MEDIAN FOLLOW-UP TIME WAS 7.5 MONTHS (RANGE, 2.4-54.2 MONTHS). AT THE TIME OF THIS ANALYSIS, 14 PATIENTS HAD DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1710569 Y-90 THERASPHERE (3 GBQ) CANADA COMM MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death