BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIR-SPHERES MICROSPHERES

    MDR report key: 6074806 · Received November 2, 2016

    Report

    Report Number
    9710358-2016-00001
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    January 1, 2016
    Report Date
    September 12, 2016
    Manufacturer
    SIRTEX MEDICAL LIMITED
    Product Code
    NAW
    PMA / PMN Number
    P990065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED DEVICE UNABLE TO BE RETURNED.

    Description of Event or Problem · 1

    FEMALE PATIENT TREATED WITH SIR-SPHERES MICROSPHERES IN APPROXIMATELY (B)(6) 2016 IS SUSPECTED TO HAVE RECEIVED AN EXCESSIVE ACTIVITY (53MCI OR 2GBQ) DELIVERED TO THE LEFT HEPATIC LOBE, AND SUBSEQUENTLY DEVELOPED RADIOEMBOLIZATION INDUCED LIVER DISEASE (ALSO REFERRED TO AS REILD OR RADIATION HEPATITIS). PATIENT INJURY WAS OBSERVED DURING DIAGNOSTIC FOLLOW-UP IMAGING BY A DIFFERENT PHYSICIAN (THE REPORTER), WHO REPORTED THAT THE PATIENT APPEARED TO HAVE EXPERIENCED AN UNINTENTIONAL RADIATION LOBECTOMY, AND THAT SHE HAD BEEN SICK FOR MANY MONTHS WITH PROLONGED RECOVERY PERIOD, BUT NOW SEEMS TO BE OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723365 SIR-SPHERES MICROSPHERES YTTRIUM-90 RESIN MICROSPHERES NAW SIRTEX MEDICAL LIMITED SIR-Y001

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability