BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIR-SPHERES MICROSPHERES

    MDR report key: 22529918 · Received July 17, 2025

    Report

    Report Number
    9710358-2025-00002
    Event Type
    Injury
    Date Received
    July 17, 2025
    Date of Event
    April 22, 2025
    Report Date
    July 17, 2025
    Manufacturer
    SIRTEX MEDICAL PTY LIMITED
    Product Code
    NAW
    UDI-DI
    00850014612030
    PMA / PMN Number
    P990065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. SIRTEX HAS LEARNED THAT THE SUBJECT WAS IN FACT DISCHARGED ON (B)(6) 2025. PRESCRIBED MEDICATION (PREDNISONE) IS STILL ON GOING AND WITH THE ANTICIPATED END DATE OF (B)(6) 2025.

    Description of Event or Problem · 0

    DOORWAY90 CLINICAL STUDY SERIOUS ADVERSE EVENT OF RADIATION PNEUMONIA (GRADE 3) LEADING TO PERSISTENT OR SIGNIFICANT DISABILITY/INCAPACITY CONSIDERED BY ADMINISTRATING PHYSICIAN TO BE PROBABLY RELATED TO THE SIR-SPHERES IMPLANT PROCEDURE. ON 05MAY2025, RESEARCH STAFF WERE REVIEWING THE SUBJECT'S MEDICAL RECORDS AND THE SUBJECT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2025 FOR ATYPICAL PNEUMONIA PER HER EMR. RESEARCH STAFF CALLED AND SPOKE WITH THE PATIENT THE SAME DAY (B)(6) 2025). THE SUBJECT SHARED THAT THEY WERE EXPERIENCING SHORTNESS OF BREATH FOR A WHILE BUT HAD BEEN ATTRIBUTING IT TO THEIR ATRIAL FIBRILLATION. THE SUBJECT WAS ADMITTED TO AN OUTSIDE HOSPITAL LOCAL TO THEIR AREA. THE SUBJECT WAS DIAGNOSED WITH RADIATION PNEUMONIA IN THE LUNGS. THE SUBJECT WAS HOSPITALIZED FOR 14 DAYS BUT EXPRESSED THAT THEY WERE FEELING BETTER AND MAY GET DISCHARGED THAT DAY (B)(6) 2025). THE SUBJECT WAS PRESCRIBED PREDNISONE (60 MG). RELATEDNESS OF THE ADVERSE EVENT TO THE SIRT MAPPING/PLANNING PROCEDURE: NOT RELATED. RELATEDNESS OF THE ADVERSE EVENT TO THE SIRT IMPLANT PROCEDURE: PROBABLY. RELATEDNESS OF THE ADVERSE EVENT TO THE STUDY DEVICE: DEFINITELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913900 SIR-SPHERES MICROSPHERES Y90 RESIN MICROSPHERES NAW SIRTEX MEDICAL PTY LIMITED SIR-Y001 SG017V05 00850014612030

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Hospitalization ATORVASTATIN (PRE-EXISTING CONDITION)| BUMETANIDE (PRE-EXISTING CONDITION)| DIGOXIN (PRE-EXISTING CONDITION)| DULOXETINE (PRE-EXISTING CONDITION)| ELIQUIS (PRE-EXISTING CONDITION)| HUMALOG MIX 75-25 KWIKPEN (PRE-EXISTING CONDITION)| HYDROMORPHONE (PRE-EXISTING CONDITION)| LEVOTHYROXINE (PRE-EXISTING CONDITION)| LOSARTAN (PRE-EXISTING CONDITION)| SEMAGLUTIDE (PRE-EXISTING CONDITION)| TAPENTADOL (PRE-EXISTING CONDITION)| XIGDUO XR (PRE-EXISTING CONDITION)