BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIR-SPHERES MICROSPHERES

    MDR report key: 6179984 · Received December 15, 2016

    Report

    Report Number
    9710358-2016-00004
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    March 20, 2016
    Report Date
    December 16, 2016
    Manufacturer
    SIRTEX MEDICAL LIMITED
    Product Code
    NAW
    PMA / PMN Number
    P990065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED DEVICE UNABLE TO BE RETURNED.

    Description of Event or Problem · 1

    PATIENT IS A (B)(6) YO FEMALE WITH MCRC WHO HAD HER PRIMARY TUMOR REMOVED. THE PATIENT WAS PREVIOUSLY TREATED WITH XELODA. CHEMO WAS TEMPORARILY STOPPED WHILE SHE WAS EVALUATED AND TREATED WITH SIR-SPHERES MICROSPHERES. ON (B)(6) 2016 THE RIGHT LOBE WAS TREATED WITH 39MCI OF SIR-SPHERES MICROSPHERES. IN (B)(6) 2016 THE LEFT LOBE WAS TREATED WITH 11MCI OF SIR-SPHERES MICROSPHERES. THE PATIENT RESPONDED TO THE THERAPY, CHEMO WAS RESTARTED AND IN (B)(6) 2016 THE CT LOOKED GOOD. IN (B)(6) 2016 THE PATIENT PRESENTED WITH ASCITES. AND IN (B)(6) OF 2016 A PARACENTESIS WAS PERFORMED TO REMOVE THE ASCITES. DOCTOR SUSPECTS PATIENT MAY BE EXPERIENCING REILD BUT DID NOT SHARE LFTS TO SUBSTANTIATE THEIR SUSPICION, BUT DID NOTE "THE PATIENT'S LABS ARE IMPROVING" AT TIME OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825900 SIR-SPHERES MICROSPHERES YTTRIUM-90 RESIN MICROSPHERES NAW SIRTEX MEDICAL LIMITED SIR-Y001

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention