BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXXENT FLEXISHIELD MINI (K090417)

    MDR report key: 1959775 · Received January 7, 2011

    Report

    Report Number
    MW5018936
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    June 24, 2010
    Report Date
    January 6, 2011
    Manufacturer
    XOFT, INC.
    Product Code
    IXI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FOLLOW-UP TO REPORT DATED 01/06/2011.

    Description of Event or Problem · 1

    EARLY STAGE BREAST CANCER (PT1B). PT WAS TREATED ON (B)(6) 2010 WITH LEFT SEGMENTAL RESECTION, SENTINEL LYMPH NODE (SLN) MAPPING, SLN DISSECTION, AND INTRAOPERATIVE RADIATION THERAPY FOLLOWED BY LEFT BREAST RECONSTRUCTION, RIGHT MASTOPLEXY FOR SYMMETRY AND REMOVAL AND REPLACEMENT OF BILATERAL IMPLANTS. PT'S 6 MONTH FOLLOW-UP MAMMOGRAM ON (B)(6) 2010 FINDINGS REPORTED "INNUMERABLE, NEW HIGH DENSITY PRESUMED CALCIFICATIONS SEEN SCATTERED IN THE LEFT (TREATED) BREAST." MRI OF THE BREAST ON (B)(6) 2010 SHOWED "NUMEROUS PUNCTATE FOCI OF MAGNETIC SUSCEPTIBILITY WITHIN THE SKIN, ALONG THE IMPLANT CAPSULE AND WITHIN THE BREAST PARENCHYMA ARE PREDOMINATELY DISTRIBUTED WITH THE POSTSURGICAL BED AND ALONG THE SURGICAL INCISION SITES. THESE LIKELY ARE ARTIFACT FROM METALLIC DEBRIS." ON (B)(6) 2010, A CORE BIOPSY WAS PERFORMED. THE (B)(6) 2011, PATHOLOGY REPORT "CONFIRMS THE PRESENCE OF HIGH DENSITY, PUNCTATE MATERIAL WITHIN SEVERAL OF THE CORE SPECIMENS." THIS REPORT IS BEING FILED WITH FDA DUE TO THE FINDINGS OF THE 6 MONTH PT FOLLOW-UP COMPLETED ON (B)(6) 2011. THE PT HAS NOT EXPERIENCED ANY ADVERSE EVENTS OR UNTOWARD EFFECTS TO DATE.

    Description of Event or Problem · 2

    FOLLOW-UP TO REPORT OF 01/07/2011 ON PT (B)(6) (#1); 3 ADDITIONAL PTS HAVE HAD MAMMOGRAPHY IMAGING SHOW SIMILAR RESULTS OF "INNUMERABLE PUNCTATE METALLIC DENSITIES...FELT TO BE ARTIFACTUAL AND APPARENTLY ARE DEBRIS LEFT FROM THE TUNGSTEN SHIELD PLACED AT THE TIME OF INTRAOPERATIVE RADIATION THERAPY" ESTABLISHING A PATTERN. NO FURTHER PTS HAVE OR WILL BE TREATED WITH THE FLEXISHIELD AT THIS FACILITY. IT IS ANTICIPATED THAT SUBSEQUENT IMAGING ON 23 ADDITIONAL PTS (N=27 TOTAL) WILL HAVE SIMILAR RESULTS ON IMAGING. NO ADVERSE EVENTS OR UNTOWARD EFFECTS HAVE BEEN REPORTED TO DATE.

    Description of Event or Problem · 3

    FOLLOW-UP TO REPORT OF 01/07/2011 ON PT (B)(6) (#1); 3 ADDITIONAL PTS HAVE HAD MAMMOGRAPHY IMAGING SHOW SIMILAR RESULTS OF "INNUMERABLE PUNCTATE METALLIC DENSITIES...FELT TO BE ARTIFACTUAL AND APPARENTLY ARE DEBRIS LEFT FROM THE TUNGSTEN SHIELD PLACED AT THE TIME OF INTRAOPERATIVE RADIATION THERAPY" ESTABLISHING A PATTERN. NO FURTHER PTS HAVE OR WILL BE TREATED WITH THE FLEXISHIELD AT THIS FACILITY. IT IS ANTICIPATED THAT SUBSEQUENT IMAGING ON 23 ADDITIONAL PTS (N=27 TOTAL) WILL HAVE SIMILAR RESULTS ON IMAGING. NO ADVERSE EVENTS OR UNTOWARD EFFECTS HAVE BEEN REPORTED TO DATE.

    Description of Event or Problem · 4

    FOLLOW-UP TO REPORT OF 01/07/2011 ON PT (B)(6) (#1); 3 ADDITIONAL PTS HAVE HAD MAMMOGRAPHY IMAGING SHOW SIMILAR RESULTS OF "INNUMERABLE PUNCTATE METALLIC DENSITIES...FELT TO BE ARTIFACTUAL AND APPARENTLY ARE DEBRIS LEFT FROM THE TUNGSTEN SHIELD PLACED AT THE TIME OF INTRAOPERATIVE RADIATION THERAPY" ESTABLISHING A PATTERN. NO FURTHER PTS HAVE OR WILL BE TREATED WITH THE FLEXISHIELD AT THIS FACILITY. IT IS ANTICIPATED THAT SUBSEQUENT IMAGING ON 23 ADDITIONAL PTS (N=27 TOTAL) WILL HAVE SIMILAR RESULTS ON IMAGING. NO ADVERSE EVENTS OR UNTOWARD EFFECTS HAVE BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXXENT FLEXISHIELD MINI (K090417) FLEXISHIELD IXI XOFT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other
    2 Other
    3 Other
    4 Other