BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIR-SPHERES MICROSPHERES

    MDR report key: 21047619 · Received December 31, 2024

    Report

    Report Number
    9710358-2024-00003
    Event Type
    Injury
    Date Received
    December 31, 2024
    Date of Event
    May 21, 2024
    Report Date
    December 31, 2024
    Manufacturer
    SIRTEX MEDICAL PTY LIMITED
    Product Code
    NAW
    UDI-DI
    M425SIRY0010
    PMA / PMN Number
    P990065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT DEVELOPED ASCITES POST Y90 SIRT THERAPY, REQUIRING INITIATION OF DIURETICS. POST Y90 HEPATIC DECOMPENSATION (E.G., NEW ONSET ASCITES) IS A RECOGNIZED POTENTIAL COMPLICATION/ADVERSE EVENT OF THIS THERAPY. THE PRINCIPAL INVESTIGATOR (PI) OF THE DOORWAY90 STUDY ASSESSED THE ADVERSE EVENT AS UNLIKELY RELATED TO SIRT MAPPING/PLANNING PROCEDURE, UNLIKELY RELATED TO SIRT IMPLANT PROCEDURE, AND PROBABLY RELATED TO THE STUDY DEVICE. A COMPREHENSIVE DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THIS PRODUCT BATCH AND DID NOT RESULT IN ANY ABNORMAL FINDINGS RELATED TO THE MANUFACTURING PROCESS. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE MALFUNCTIONED OR WAS NOT USED AS INTENDED.

    Description of Event or Problem · 0

    DOORWAY90 CLINICAL STUDY PATIENT EXPERIENCED ABDOMINAL PAIN, NAUSEA, AND VOMITING. PATIENT DEVELOPED ASCITES WHICH RESULTED IN PROLONGATION OF HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1752881 SIR-SPHERES MICROSPHERES Y90 RESIN MICROSPHERES NAW SIRTEX MEDICAL PTY LIMITED SIR-Y001 SD024V02 M425SIRY0010

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization