BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMBOSPHERE MICROSPHERES

    MDR report key: 4336967 · Received November 26, 2014

    Report

    Report Number
    9615728-2014-00004
    Event Type
    Death
    Date Received
    November 26, 2014
    Date of Event
    April 25, 2014
    Report Date
    November 4, 2014
    Manufacturer
    BIOSPHERE MEDICAL, S.A.
    Product Code
    NAJ
    PMA / PMN Number
    K021397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S TEST RESULTS PERFORMED ON (B)(6) 2014, BEFORE THE DEVICE WAS USED, ALREADY SHOWED DETERIORATED LIVER FUNCTION. THE CAUSE OF DEATH WAS CONSIDERED TO BE THE PROGRESSION OF ACIDOSIS ASSOCIATED WITH MASSIVE TUMOR SELL LYSIS IN THE PRESENCE OF MULTIPLE TUMORS AND HEPATIC CIRRHOSIS. CAUSAL RELATIONSHIP BETWEEN TUMOR LYSIS SYNDROME AND DEVICE HAS NOT BEEN FOUND. SINCE THE LOT HUMBER WAS NOT PROVIDED, THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT PATIENT WITH HEPATOCELLULAR CARINOMA (STAGE III) DIED ONE DAY AFTER HAVING RECEIVED TRANS-ARTERIAL EMBOLIZATION WITH THE DEVICE. ON (B)(6) 2014, 2 SYRINGES OF EMBOSPHERE WERE USED FOR TRANS-ARTERIAL EMBOLIZATION. EXACERBATION OF DIFFICULTY BREATHING AND MALAISE WAS NOTED, AND DESPITE INITIATION OF CONTINUOUS HEMO-FILTRATION (CHR) AND ACIDOSIS PROGRESSED. ON (B)(6) 2014, THE PATIENT DIED. THE CAUSE OF DEATH WAS CONSIDERED TO BE THE PROGRESSION OF ACIDOSIS ASSOCIATED WITH MASSIVE TUMOR SELL LYSIS IN THE PRESENCE OF MULTIPLE TUMORS AND HEPATIC CIRRHOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767567 EMBOSPHERE MICROSPHERES AGENTS, EMBOLIC, TREAT. UTER. FIBRO. NAJ BIOSPHERE MEDICAL, S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death