BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIR-SPHERES MICROSPHERES

    MDR report key: 6179982 · Received December 15, 2016

    Report

    Report Number
    9710358-2016-00003
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    December 1, 2015
    Report Date
    December 14, 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

    DOCTOR TREATED PATIENT (B)(6) IN (B)(6) 2015. (B)(6) IS A (B)(6) YEAR OLD MALE WITH MCRC. (B)(6) HAS THE PRIMARY TUMOR INTACT. THE PATIENT WAS TREATED WITH FOLFOX AND AVASTIN. (B)(6) HAD NO OTHER UNDERLYING LIVER DISEASE. THE PATIENT WAS TREATED WITH 40.5 MCI OF SIR-SPHERES MICROSPHERES IN THE RIGHT LOBE FOLLOWING EMBOLIZATION OF THE GDA. A FOLLOW-UP MRI IN (B)(6) 2016 SHOWED NO REMARKABLE FINDINGS. IN (B)(6) 2016, THE PATIENT PRESENTED WITH ASCITES, DECREASED LIVER FUNCTION, ELEVATED BILIRUBIN, INCREASED ALK PHOS. IN (B)(6), DOCTOR DRAINED THE ASCITES. ON (B)(6) 2016 DOCTOR DISCUSSED THE ISSUE AND STATED THAT THE PATIENT WAS IMPROVING BUT CONTINUES TO HAVE ASCITES AND SIGNS OF A CIRRHOTIC LIVER. DOCTOR FURTHER ADVISED ON (B)(6) 2016 THAT PATIENT LAB VALUES HAVE RESOLVED; HOWEVER, THE PATIENT HAD PROLONGED ASCITES WHICH HAS REQUIRED SURGICAL/MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826737 SIR-SPHERES MICROSPHERES YTTRIUM-90 RESIN MICROSPHERES NAW SIRTEX MEDICAL LIMITED SIR-Y001

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention