BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE

    MDR report key: 11726661 · Received April 26, 2021

    Report

    Report Number
    3002124543-2021-00012
    Event Type
    Injury
    Date Received
    April 26, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 26, 2021
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEVER OCCURRED. ON (B)(6) 2021, THE PATIENT WAS ENROLLED INTO THE (B)(6) STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON SAME DAY. 1.67 GBQ WAS ADMINISTERED THROUGH VIAL-1 AND 1.51 GBQ WAS ADMINISTERED THROUGH VIAL-2. TOTAL DOSE OF 3.18 GBQ WAS ADMINISTERED TO THE PATIENT. POST-TREATMENT MACROAGGREGATED ALBUMIN (MAA) IMAGING DOCUMENTED A STRONG UPTAKE OF MAA ON TUMORS, DOSES TO PERFUSED LIVER WAS 100 GY AND DOSE TO PERFUSED TUMOR WAS 151 GY. ON (B)(6) 2021, 50 DAYS POST THERASPHERE ADMINISTRATION, THE PATIENT DEVELOPED FEVER (39.5 CELSIUS) AND WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT ON (B)(6) 2021. THE PATIENT WAS TREATED WITH CONCOMITANT MEDICATION AND THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2021. PATIENT WAS DISCHARGED ON THE SAME DAY. THIS EVENT IS LISTED AS CAUSALLY RELATED TO THERASPHERE. NO FURTHER PATIENT EVENTS WERE REPORTED. NO OTHER INFORMATION IS KNOWN AT THIS TIME. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622176 THERASPHERE YTTRIUM-90 GLASS MICROSPHERES NAW

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention