BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR PVA MICROSPHERES

    MDR report key: 2402669 · Received January 6, 2012

    Report

    Report Number
    2134265-2012-00042
    Event Type
    Injury
    Date Received
    January 6, 2012
    Date of Event
    October 21, 2011
    Report Date
    December 9, 2011
    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

    IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2012-00102, 2134265-2012-00103, 2134265-2012-00104, 2134265-2012-00105, 2134265-2012-00106, 2134265-2012-00107. 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 300-500 UM CONTOUR PVA MICROSPHERES. THE OTHER SIDE WAS TREATED USING 3 BOTTLES OF 300-500 UM CONTOUR PVA MICROSPHERES AND 1 BOTTLE OF 500-700 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