BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMBOSPHERE®

    MDR report key: 15638439 · Received October 20, 2022

    Report

    Report Number
    9615728-2022-00003
    Event Type
    Death
    Date Received
    October 20, 2022
    Date of Event
    September 1, 2017
    Report Date
    October 7, 2022
    Manufacturer
    MERIT MEDICAL, INC
    Product Code
    NAJ
    UDI-DI
    00884450403440
    PMA / PMN Number
    K021397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. A FOLLOW UP WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE COULD NOT BE RETURNED FOR INVESTIGATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE IMPLANT DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED. THERE IS NO EVIDENCE TO SUGGEST THAT ANY MANUFACTURING-RELATED CONCERNS CONTRIBUTED TO THE ADVERSE EVENT.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT IN (B)(6) 2017, AFTER A UTERINE ARTERY EMBOLIZATION PROCEDURE WHERE EMBOLICS WERE USED, THE PATIENT DIED. DEATH CAUSED BY ACUTE RIGHT HEART FAILURE DUE TO PULMONARY INFARCTION DURING UAE (UTERINE ARTERY EMBOLIZATION) PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2803748 EMBOSPHERE® AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS NAJ MERIT MEDICAL, INC 00884450403440 00884450403440

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death