BEUDAMED
    FDA Adverse Event Death Summary report: N

    Y-90 THERASPHERE (3 GBQ) CANADA COMM

    MDR report key: 12816536 · Received November 15, 2021

    Report

    Report Number
    2134265-2021-14303
    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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: GUICHET, P. L., TASLAKIAN, B., ZHAN, C., AALTONEN, E., FARQUHARSON, S., HICKEY, R., HORN, C. J., & GROSS, J. S. (2021). MRI-DERIVED SARCOPENIA ASSOCIATED WITH INCREASED MORTALITY FOLLOWING YTTRIUM-90 RADIOEMBOLIZATION OF HEPATOCELLULAR CARCINOMA. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 44(10), 1561-1569. HTTPS://DOI.ORG/10.1007/S00270-021-02874-6. DATE OF DEATH: BETWEEN DECEMBER 2013 AND DECEMBER 2017. DATE OF EVENT: BETWEEN DECEMBER 2013 AND DECEMBER 2017 - UNKNOWN DATE USED WAS THE FIRST DAY OF THE MONTH BSC WAS MADE AWARE, 1OCTOBER, 2021. IMPLANT DATE - BETWEEN DECEMBER 2013 AND DECEMBER 2017.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE ARTICLE: "MRI-DERIVED SARCOPENIA ASSOCIATED WITH INCREASED MORTALITY FOLLOWING YTTRIUM-90 RADIOEMBOLIZATION OF HEPATOCELLULAR CARCINOMA" DEATH OCCURRED. THE PURPOSE OF THE ARTICLE IS TO EVALUATE THE INFLUENCE OF SARCOPENIA ON SURVIVAL IN PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) TREATED WITH 90Y RADIOEMBOLIZATION. A SINGLE-CENTER RETROSPECTIVE COHORT STUDY ANALYZED 82 CONSECUTIVE PATIENTS (65 MEN AND17 WOMEN, MEAN AGE 65 YEARS, RANGE 31-83 YEARS) WITH HCC TREATED WITH 90Y RADIOEMBOLIZATION BETWEEN DECEMBER 2013 AND DECEMBER 2017. SARCOPENIA WAS ASSESSED ON PRE-PROCEDURE MRI PERFORMED WITHIN 100 DAYS PRIOR TO 90Y RADIOEMBOLIZATION BY SEGMENTING THE PARASPINAL MUSCULATURE AT THE LEVEL OF THE SUPERIOR MESENTERIC ARTERY ORIGIN AND SUBTRACTING FAT-INTENSITY PIXELS TO YIELD FAT-FREE MUSCLE AREA (FFMA). SARCOPENIA WAS DEFINED AS FFMA B31.97 CM2 FOR MEN AND B28.95 CM2 FOR WOMEN. SURVIVAL AT 90 DAYS, 180 DAYS, 1 YEAR, AND 3 YEARS FOLLOWING INITIAL TREATMENT WAS ASSESSED USING MEDICAL AND PUBLIC OBITUARY RECORDS. SARCOPENIA WAS IDENTIFIED IN 30% OF PATIENTS. DEATH WAS REPORTED FOR 49% OF MALES AND 71% OF FEMALES (MEAN FOLLOW-UP 19.6 MONTHS, RANGE 21 DAYS-58 MONTHS). PATIENTS WITH SARCOPENIA WERE FOUND TO HAVE INCREASED MORTALITY AT 180 DAYS (31.8% VS. 8.9%) AND 1 YEAR (68.2% VS. 21.2%). SARCOPENIA WAS AN INDEPENDENT PREDICTOR OF MORTALITY ADJUSTED FOR BCLC STAGE AND SUB-ANALYSIS DEMONSTRATED THAT SARCOPENIA INDEPENDENTLY PREDICTED INCREASED MORTALITY FOR PATIENTS WITH BCLC STAGEB DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1712706 Y-90 THERASPHERE (3 GBQ) CANADA COMM MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death