BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE

    MDR report key: 7421023 · Received April 11, 2018

    Report

    Report Number
    3002124543-2018-00024
    Event Type
    Injury
    Date Received
    April 11, 2018
    Date of Event
    October 22, 2016
    Report Date
    March 16, 2018
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENTS WERE NOT REPORTED TO BTG BY THE TREATING PHYSICIAN AT THE TIME OF THE EVENT IN 2016. THE EVENTS WERE REPORTED THROUGH A RETROSPECTIVE CLINICAL TRIAL. CHOLECYSTITIS IS LISTED AS A KNOWN ADVERSE EVENT POSSIBLY ASSOCIATED WITH THERASPHERE TREATMENT. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO DEVICE MALFUNCTION WAS REPORTED. THE LOT NUMBER ASSOCIATED WITH THE THERASPHERE ADMINISTRATION WAS NOT REPORTED THEREFORE NO INVESTIGATION COULD BE PERFORMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS IS A FOLLOW UP REPORT TO CORRECT THE SUBJECT NUMBER AND AGE IN THE EVENT DESCRIPTION. NO OTHER CHANGES MADE. REFER TO INITIAL REPORT FOR CONCLUSION. SUBJECT (B)(6) IS A (B)(6) YEAR OLD MALE PATIENT.

    Description of Event or Problem · 1

    SUBJECT (B)(6) IS AN (B)(6) YEAR OLD MALE PATIENT ENROLLED IN THE BTG CLINICAL STUDY TARGET ((B)(6), TARGET: (B)(6).) A RETROSPECTIVE REVIEW OF THIS PATIENT'S CHART IDENTIFIED A SERIOUS ADVERSE EVENT FOLLOWING THE ADMINISTRATION OF THERASPHERE. THIS PATIENT WAS ADMINISTERED 2.59 GBQ OF THERASPHERE ON (B)(6) 2016. ON (B)(6) 2016, THE SUBJECT WAS DIAGNOSED WITH ACUTE CHOLECYSTITIS (GRADE 3/SEVERE). THE SUBJECT WAS HOSPITALIZED AND UNDERWENT A CHOLECYSTECTOMY. THE PI ASSESSED THE EVENT AS SERIOUS AND POSSIBLY RELATED TO THE THERASPHERE. THE PATIENT RECOVERED AND THE EVENT WAS REPORTED AS RESOLVED ON (B)(6) 2016. THIS EVENT WAS NOT REPORTED TO BTG BY THE TREATING PHYSICIAN AT THE TIME OF THE EVENT IN 2016.

    Description of Event or Problem · 1

    THIS IS A FOLLOW UP REPORT TO CORRECT THE SUBJECT NUMBER AND AGE IN THE EVENT DESCRIPTION. NO OTHER CHANGES MADE. SUBJECT (B)(6) IS A (B)(6) YEAR OLD MALE PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264311 THERASPHERE YTTRIUM-90 GLASS MICROSPHERES NAW BIOCOMPATIBLES UK LTD UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R