BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERASPHERE

    MDR report key: 11771173 · Received May 4, 2021

    Report

    Report Number
    3002124543-2021-00014
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    October 21, 2020
    Report Date
    May 4, 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

    DEVICE EVALUATED BY MANUFACTURER: THE LOT NUMBER WAS NOT REPORTED AND THEREFORE A MANUFACTURING BATCH RECORD REVIEW COULD NOT BE COMPLETED. THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABDOMINAL PAIN OCCURRED. IN (B)(6) 2020, SUBJECT (B)(6) SUBJECT WAS ENROLLED INTO THE (B)(6) STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY. TYPE OF THERASPHERE INFUSION WAS IN THE RIGHT HEPATIC ARTERY (IRRESPECTIVE OF ORIGIN) (SEGMENTS V/VI/VII/VIII). 7.30 GBQ WAS ADMINISTERED TO THE LIVER (RIGHT LIVER) THROUGH VIAL 1. 9 DAYS POST TREATMENT WITH THERASPHERE, THE SUBJECT PRESENTED WITH ABDOMINAL PAIN. IN (B)(6) 2020, 25 DAYS LATER, THE SUBJECT WAS HOSPITALIZED IN OTHER INSTITUTION FOR FURTHER EVALUATION AND TREATMENT. AS A TREATMENT, THE SUBJECT WAS PRESCRIBED WITH LOVENOX, OXYNORM BRO 5 MG AND INNOHEP 18000 U. 5 DAYS LATER, THE SUBJECT WAS DISCHARGED FROM HOSPITAL. IN (B)(6) 2020, 30 DAYS LATER, THE EVENT WAS CONSIDERED RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669243 THERASPHERE YTTRIUM-90 GLASS MICROSPHERES NAW

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization