BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERASPHERE

    MDR report key: 7503296 · Received May 10, 2018

    Report

    Report Number
    3002124543-2018-00032
    Event Type
    Death
    Date Received
    May 10, 2018
    Report Date
    April 10, 2018
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS NOT REPORTED TO THE MANUFACTURER AS A COMPLAINT AGAINST THERASPHERE. A SEARCH DID NOT RETURN ANY LIKELY MATCH ASSOCIATED WITH THE PARTICIPANT ON THE BTG LIVE WEBINAR. NO FOLLOW UP COULD BE PERFORMED. LIMITED INFORMATION IS AVAILABLE IN ASSOCIATION WITH THIS PATIENT DEATH. A PATIENT OF UNKNOWN AGE AND SEX WAS ADMINISTERED AN UNKNOWN DOSE OF Y90 ON AN UNKNOWN DATE. FOLLOWING THE ADMINISTRATION, WITHIN 4 WEEKS, THE PATIENT EXPERIENCED VENOUS OCCLUSIVE DISEASE AND DIED. NO OTHER PATIENT OR PROCEDURE INFORMATION IS AVAILABLE. THIS PATIENT DEATH IS BEING REPORTED IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    ON 10 APRIL 2018 A BTG EMPLOYEE WAS WATCHING A BTG LIVE WEBINAR TITLED "EXPANDING THE APPLICATION OF Y90 IN HEPATOCELLULAR CARCINOMA: TREATING ACROSS THE BCLC PARADIGM" AND REPORTED THAT A PARTICIPANT USED THE CHAT FUNCTION TO ASK A QUESTION REGARDING ONE OF HER PATIENTS. THE PARTICIPANT ASKED IF THE FACILITATOR HAD ANY DATA ON OR EXPERIENCE MANAGING OR PREVENTING HEPATIC VENOUS OCCLUSIVE DISEASE POST Y90. THE PARTICIPANT POSTED THAT SHE RECENTLY LOST A PATIENT TO VOD (VENOUS OCCLUSIVE DISEASE) POST Y90.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345655 THERASPHERE YTTRIUM-90 GLASS MICROSPHERES NAW BIOCOMPATIBLES UK LTD UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death