BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR PVA MICROSPHERES

    MDR report key: 2433082 · Received January 31, 2012

    Report

    Report Number
    2134265-2012-00107
    Event Type
    Injury
    Date Received
    January 31, 2012
    Date of Event
    October 21, 2011
    Report Date
    January 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    NAJ
    PMA / PMN Number
    K030966
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR# 2134265-2012-00042, 2134265-2012-00102, 2134265-2012-00103, 2134265-2012-00104, 2134265-2012-00105, 2134265-2012-00106. IT WAS REPORTED THAT POST A UTERINE FIBROID EMBOLIZATION (UFE) TREATMENT PROCEDURE, SEVERE POST EMBOLIZATION SYNDROME WAS EXPERIENCED. THE PATIENT PRESENTED FOR A UFE PROCEDURE WITH SYMPTOMS OF SWELLING AND BLEEDING. THE PATIENT HAD 30 FIBROIDS. THE PATIENT WAS TREATED ON ONE SIDE USING 3 BOTTLES OF 355 - 500 UM CONTOUR PVA MICROSPHERES. THE OTHER SIDE WAS TREATED USING 3 BOTTLES OF 355 - 500 UM CONTOUR PVA MICROSPHERES AND 1 BOTTLE OF 500-710 UM CONTOUR PVA MICROSPHERES. THERE WAS COMPLETE OCCLUSION OF THE VESSELS AND ALL THE FIBROIDS DIED. FOLLOWING THE PROCEDURE, THE PATIENT CONTINUED TO HAVE AN ELEVATED TEMPERATURE AND INCREASED LEVELS OF LEUKOCYTOSIS AND INFLAMMATORY PROTEINS REQUIRING HOSPITALIZATION FOR ONE MONTH POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR PVA MICROSPHERES AGENTS, EMBOLIC, FOR TREATMENT OF UTERINE FIBROIDS NAJ BOSTON SCIENTIFIC - CORK UNK90

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O