BEUDAMED
    FDA Adverse Event Death Summary report: N

    Y-90 THERASPHERE (3 GBQ) CANADA COMM

    MDR report key: 12814322 · Received November 15, 2021

    Report

    Report Number
    2134265-2021-14302
    Event Type
    Death
    Date Received
    November 15, 2021
    Date of Event
    October 1, 2021
    Report Date
    November 15, 2021
    Manufacturer
    BIOCOMPATIBLES UK LIMITED
    Product Code
    NAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APA7 CITATION: SRINIVAS, S., HSIEH, L., ROCKWELL, H., DUNCAN, D., ROSE, S., MINOCHA, J., & BERMAN, Z. (2021). ABSTRACT NO. 33 SAFETY AND EFFICACY OF TRANSARTERIAL RADIOEMBOLIZATION AFTER PRIOR TRANSARTERIAL CHEMOEMBOLIZATION. JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 32(5), S15-S16. HTTPS;//DOI.ORG/10.1016/J.JVIR.2021.03.449. DATE OF EVENT - DATE IS UNKNOWN, USE FIRST OF THE MONTH BSC WAS MADE AWARE, 10/1/2021. DATE OF DEATH - (B)(6) 2017 - (B)(6) 2019. IMPLANT DATE - (B)(6) 2017 - (B)(6) 2019.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA THE LITERATURE ARTICLE: "SAFETY AND EFFICACY OF TRANSARTERIAL RADIOEMBOLIZATION AFTER PRIOR TRANSARTERIAL CHEMOEMBOLIZATION" DEATH OCCURRED. TRANSARTERIAL RADIOEMBOLIZATION (TARE) IS A COMMON TECHNIQUE TO TREAT PATIENTS WITH HEPATOCELLULAR CARCINOMA REFRACTORY TO TRANSARTERIAL CHEMOEMBOLIZATION (TACE). TARE CAN CAUSE LIVER TOXICITY. THE DEGREE OF TOXICITY MAY BE HEIGHTENED DUE TO PREVIOUS LIVER INJURY FROM PRIOR ENDOVASCULAR THERAPIES. THIS STUDY ASSESSED THE SAFETY AND CHANGES IN LIVER FUNCTION AFTER TARE FOR MULTIFOCAL HEPATOCELLULAR CARCINOMA REFRACTORY TO PREVIOUS EMBOLIZATION. A RETROSPECTIVE CHART REVIEW WAS PERFORMED BETWEEN 2017 AND 2019 TO IDENTIFY PATIENTS WHO UNDERWENT TACE OR BLAND EMBOLIZATION FOLLOWED BY TARE FOR HEPATOCELLULAR CARCINOMA. DEMOGRAPHIC, LABORATORY, AND IMAGING INFORMATION WAS COLLECTED PRIOR TO TARE AND 3, 6, 9, 12, 18, AND 24 MONTHS AFTER TARE. 30 PATIENTS WERE INCLUDED. MEAN AGE WAS 67.5 YEARS (53-89), 10 WERE FEMALES. THERE WAS A MEDIAN OF 2 PRIOR LESION SPECIFIC TREATMENTS FOR EACH PATIENT. THE MEAN PRESCRIBED Y90 ACTIVITY PER WAS 2.6 GBQ. THIRTEEN PATIENTS DIED. THERE WERE THREE MORTALITIES THAT COULD BE ATTRIBUTED TO RADIOEMBOLIZATION-INDUCED LIVER DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1709883 Y-90 THERASPHERE (3 GBQ) CANADA COMM MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death