BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIR-SPHERES MICROSPHERES

    MDR report key: 22873954 · Received August 22, 2025

    Report

    Report Number
    3005579300-2025-00018
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    November 20, 2024
    Report Date
    August 22, 2025
    Manufacturer
    SIRTEX MEDICAL PTY LIMITED
    Product Code
    NAW
    UDI-DI
    00850014612146
    PMA / PMN Number
    P990065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIRTEX FOLLOWED UP WITH THE PHYSICIAN AND WAS TOLD THE "PATIENT STAYED OVERNIGHT AND WAS IN SOME PAIN" AND NO OTHER DETAILS WERE PROVIDED. PAIN IS AN EXPECTED ADVERSE EVENT LISTED IN THE IFU. SIRTEX MEDICAL AFFAIRS HAS STATED THAT STASIS IS A PROCEDURAL COMPLICATION AND COULD BE CONSIDERED AN ADVERSE EVENT SHOULD THE PATIENT BE UNDER DOSED. IT WAS ALSO STATED THAT STASIS MOST COMMONLY OCCURS DUE TO THE PATIENT'S PHYSIOLOGY. BATCH RECORD REVIEW SHOWED THE DEVICE WAS MANUFACTURED TO RELEASED SPECIFICATIONS AND HAD PASSING QUALITY TEST RESULTS. A RETROSPECTIVE MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE POTENTIAL FOR SERIOUS INJURY SHOULD THE FULL DOSE NOT BE ABLE TO BE ADMINISTERED.

    Description of Event or Problem · 0

    PHYSICIAN REACHED STASIS UNEXPECTEDLY. THE PATIENT STAYED OVERNIGHT AND WAS IN SOME PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2666939 SIR-SPHERES MICROSPHERES Y90 RESIN MICROSPHERES NAW SIRTEX MEDICAL PTY LIMITED SIR-Y002 SK032 00850014612146

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other