BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIR-SPHERES MICROSPHERES

    MDR report key: 6074868 · Received November 2, 2016

    Report

    Report Number
    9710358-2016-00002
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    December 1, 2015
    Report Date
    September 20, 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

    MALE PATIENT WITH CRCLMS WAS TREATED WITH SIR-SPHERES Y-90 RESIN MICROSPHERES IN (B)(6) 2015 WITH 2GBQ OF ACTIVITY ADMINISTERED TO THE RIGHT LOBE, WHICH THE REPORTER BELIEVED WAS APPROXIMATELY TWO TIMES MORE THAN THEY CONSIDERED APPROPRIATE. THE REPORTER STATED HE WAS NOT THE TREATING PHYSICIAN BUT BECAME AWARE OF THE PATIENT HAVING DEVELOPED RADIOEMBOLIZATION INDUCED LIVER DISEASE (REILD) WHEN HE WAS PERFORMING THE DIAGNOSTIC FOLLOW-UP IMAGING, WHICH DEMONSTRATED THAT THE PATIENT'S RIGHT HEPATIC LOBE HAD EVIDENCE OF RADIATION INJURY AND THE PATIENT HAD DEVELOPED FLORID ABDOMINAL ASCITES. THE REPORTER STATED THAT THE PATIENT HAD EXPERIENCED CR ON FOLLOW-UP IMAGING BUT THAT HE HAD DEVELOPED CHRONIC ASCITES REQUIRING WEEKLY PARACENTESIS (PERFORMED BY THE REPORTER). THE PATIENT OTHERWISE HAD RELATIVELY NORMAL LIVER FUNCTION, HOWEVER IN THE ABSENCE OF RADIOLOGICAL EVIDENCE OF TUMOUR PROGRESSION, THE ASCITES WAS CONSIDERED TO BE LIKELY DUE TO REILD FROM SIRT WITH SIR-SPHERES MICROSPEHRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724966 SIR-SPHERES MICROSPHERES YTTRIUM-90 RESIN MICROSPHERES NAW SIRTEX MEDICAL LIMITED SIR-Y001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S