BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCOZENE MICROSPHERES

    MDR report key: 15166725 · Received August 4, 2022

    Report

    Report Number
    2134265-2022-08365
    Event Type
    Injury
    Date Received
    August 4, 2022
    Date of Event
    January 6, 2022
    Report Date
    August 4, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER FACILITY NAME: (B)(6). VOIZARD, NICOLAS, ET AL. "SMALL PARTICLE DEBIRI TACE AS SALVAGE THERAPY IN PATIENTS WITH LIVER DOMINANT COLORECTAL CANCER METASTASIS: RETROSPECTIVE ANALYSIS OF SAFETY AND OUTCOMES." CURRENT ONCOLOGY 29.1 (2022): 209-220.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A JOURNAL ARTICLE THAT PATIENT COMPLICATIONS OCCURRED. ABSTRACT: THE AIM OF THIS STUDY WAS TO EXAMINE THE SAFETY AND EFFICACY OF 40 MICROMETER AND 75 MICROMETER CALIBRATED IRINOTECAN-ELUTING BEADS (DEBIRI-TACE) FOR THE TREATMENT OF COLORECTAL CANCER METASTASES. WE CONDUCTED A RETROSPECTIVE REVIEW OF 36 PATIENTS WITH UNRESECTABLE LIVER METASTASES FROM COLORECTAL CANCER WHO WERE TREATED WITH DEBIRI-TACE BETWEEN 2017 TO 2020. PATIENTS WHO RECEIVED AT LEAST ONE SESSION OF DEBIRI WERE INCLUDED IN OUR ANALYSIS. A TOTAL OF 105 DEBIRI SESSIONS WERE COMPLETED. 86% OF PATIENTS (N = 31) UNDERWENT ONE ROUND OF TREATMENT, 14% OF PATIENTS (N = 5) UNDERWENT TWO DISTINCT ROUNDS OF TREATMENT. THE MAJORITY OF PATIENTS WERE DISCHARGED THE NEXT DAY (92%, N = 33 PATIENTS) WITH NO 30-DAY POST-DEBIRI MORTALITY. FIVE HIGH-GRADE ADVERSE EVENTS OCCURRED, INCLUDING LONGER STAY FOR PAIN MANAGEMENT (N = 2), POSTEMBOLIZATION SYNDROME REQUIRING READMISSION (N = 2), AND LIVER ABSCESS (N = 1). THE AVERAGE SURVIVAL FROM DIAGNOSIS OF METASTATIC DISEASE WAS 33.3 MONTHS (RANGE 11 - 95, MEDIAN 28). NINE OF 36 PATIENTS ARE STILL ALIVE (DECEMBER 2020) AND HAVE AN AVERAGE FOLLOW-UP TIME OF 36.8 MONTHS FROM T0 (RANGE 12 - 63, MEDIAN 39). SMALL PARTICLE DEBIRI IS SAFE AND WELL-TOLERATED IN THE SALVAGE SETTING, WITH OUTCOMES COMPARABLE TO THAT OF LARGER BEAD SIZES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1721030 ONCOZENE MICROSPHERES DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other