BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMBOZENE MICROSPHERES

    MDR report key: 12158176 · Received July 13, 2021

    Report

    Report Number
    2134265-2021-08849
    Event Type
    Death
    Date Received
    July 13, 2021
    Date of Event
    July 17, 2020
    Report Date
    July 13, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NAJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EVENT DATE NOT PROVIDED AND PUBLICATION DATE OF JOURNAL ARTICLE WAS USED. SEBASTIAN, NIKHIL T., ET AL. "A PILOT TRIAL EVALUATING STEREOTACTIC BODY RADIATION THERAPY TO INDUCE HYPEREMIA IN COMBINATION WITH TRANSARTERIAL CHEMOEMBOLIZATION FOR HEPATOCELLULAR CARCINOMA." INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY* BIOLOGY* PHYSICS 108.5 (2020): 1276-1283.

    Description of Event or Problem · 1

    IT WAS REPORTED A SUBJECT PASSED AWAY FOLLOWING TRANSARTERIAL CHEMOEMBOLIZATION (TACE) VIA A JOURNAL ARTICLE. SIXTEEN PATIENTS WERE ENROLLED THE STUDY. 13 PATIENTS RECEIVED SINGLE-FRACTION STEREOTACTIC BODY RADIATION THERAPY (SBRT) FOLLOWED BY TACE WITHIN 24 HOURS. MEDIAN FOLLOW-UP WAS 15.3 MONTHS. THE MOST COMMON TOXICITIES WERE FATIGUE (46.2%), ABDOMINAL PAIN (38.5%), AND NAUSEA (38.5%). CRUDE RATES OF GRADE 1 OR HIGHER AND GRADE 2 OR HIGHER TOXICITY WERE 85% AND 38%, RESPECTIVELY. THERE WERE NO GRADE 3 OR 4 TOXICITIES. ONE PATIENT IN COHORT 2 DIED OF INTRAPERITONEAL HEMORRHAGE 4 DAYS AFTER TACE (GRADE 5 TOXICITY), WHICH WAS PROBABLY RELATED TO PROTOCOL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054830 EMBOZENE MICROSPHERES EMBOLIC DEVICE NAJ BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death