BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 4091897 · Received August 20, 2014

    Report

    Report Number
    3002124545-2014-00019
    Event Type
    Death
    Date Received
    August 20, 2014
    Date of Event
    July 24, 2014
    Report Date
    August 19, 2014
    Manufacturer
    BIOCOMPATIBLES U.K. LIMITED
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS COMPLAINT IS ONGOING AND FURTHER INFORMATION WILL BE REQUESTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A METASTATIC COLORECTAL CANCER PATIENT (PATIENT INFORMATION NOT PROVIDED) WHO EXPERIENCED BILIARY OBSTRUCTION POST RADIOEMBOLIZATION WITH THERASPHERE. PRIOR TO TREATMENT THE PATIENT PRESENTED WITH NO EXTRAHEPTIC METASTASES WITH LESION AND ECOG SCORE OF 0. THE DOMINANT LESION WAS IN SEGMENT 4. ON AN UNKNOWN DATE THE PATIENT RECEIVED LEFT LOBE INFUSION TO SEGMENT 2,3 AND 4 WITH THE MAJORITY OF MICROSPHERES DEPOSITING IN SEGMENT 4 BASED ON FLOW DYNAMICS. THE REPORTED INCIDENT DATE WAS (B)(4) 2014 WHICH WAS APPROXIMATELY ONE WEEK POST TREATMENT THE PATIENT'S BILIRUBIN LEVELS WERE 15MG/DL AND THE PHYSICIAN SUSPECTED BILIARY OBSTRUCTION. BILIARY DRAINAGE WAS PERFORMED ON AN UNKNOWN DATE BUT AT THE TIME OF REPORTING THE PATIENT'S BILIRUBIN LEVELS REMAINED HIGH AND CONTINUED TO VACILLATE BETWEEN 10 AND 15 MG/DL. THE REPORTING PHYSICIAN WAS CONCERNED THAT THEY MAY BE OBSERVING RADIATION INDUCED LIVER DISEASE (RILD) OR SOME FORM OF LIVER DECOMPENSATION BUT DIAGNOSIS WAS NOT CONFIRMED AT THE TIME OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503736 THERASPHERE NONE NAW BIOCOMPATIBLES U.K. LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other