BEUDAMED
    FDA Adverse Event Death Summary report: N

    LC BEAD

    MDR report key: 3836174 · Received April 25, 2014

    Report

    Report Number
    3002124545-2014-00004
    Event Type
    Death
    Date Received
    April 25, 2014
    Report Date
    April 24, 2014
    Manufacturer
    BIOCOMPATIBLES U.K. LIMITED
    Product Code
    HCG
    PMA / PMN Number
    K094018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LC BEAD LOADED WITH DOXORUBICIN WAS USED IN THE TREATMENT OF THIS PATIENT. LC BEAD IS NOT INDICATED FOR USE WITH DRUGS IN THE USA. THE DEVICE HAS NOT BEEN SENT TO THE MFR FOR EVAL. NO BATCH REVIEW WAS POSSIBLE FOR THIS CASE AS THE LOT NUMBER COULD NOT BE ASCERTAINED. NO PRODUCT MALFUNCTION/DEFICIENCY HAS BEEN IDENTIFIED. THE INVESTIGATION INTO THIS REPORT IS ONGOING. COMPANY MEDICAL ASSESSMENT: THIS PATIENT HAD VERY EXTENSIVE INVOLVEMENT OF THE LIVER WITH TUMOR PRIOR TO THE PROCEDURE. IT IS IMPOSSIBLE TO KNOW IF LIVER FAILURE WOULD HAVE OCCURRED DUE TO DISEASE PROGRESSION ANYWAY OR IF THE CHEMOEMBOLIZATION PROCEDURE TRIGGERED THE LIVER FAILURE. WHILST THE DEVICE DID NOT MALFUNCTION, IT COULD BE ARGUED THAT THIS PATIENT HAD TOO MUCH DISEASE FOR SAFE TACE, THEREFORE, IMPLYING A POTENTIAL "USER ERROR". THEREFORE, THIS CASE WAS ASSESSED AS MEDICALLY REPORTABLE. PATIENT CONTINUED INVOLVEMENT IN A FURTHER CLINICAL STUDY PRIOR TO TACE PROCEDURE.

    Description of Event or Problem · 1

    INITIAL REPORT RECEIVED VIA U.S MAIL. ADD'L DATA RELATING TO THE PATIENT DEATH RECEIVED ON (B)(4) 2014. PATIENT WITH ER-/PR-HER2+ BREAST CANCER DIAGNOSED AT AGE (B)(6) WITH LIVER METASTASES DIAGNOSED AT AGE (B)(6). PATIENT UNDERWENT SURGERY AND RECEIVED MULTIPLE DIFFERENT LINES OF SYSTEMIC CHEMOTHERAPY. PATIENT HAD RECEIVED NO PRIOR LIVER DIRECTED THERAPY. AT THE TIME OF TREATMENT, THE PATIENT HAD LIVER METASTASES WITH 50-75% LIVER INVOLVEMENT AND IMAGING EVIDENCE OF PORTAL HYPERTENSION. PATIENT RECEIVED A SINGLE TACE TREATMENT OF 70-150 BEADS LOADED WITH 150MG DOXORUBICIN. SIX WEEKS FOLLOWING THE TACE PROCEDURE, THE PATIENT DIED DUE TO LIVER FAILURE RELATED TO PROGRESSION OF CANCER AND DECOMPENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250449 LC BEAD EMBOLIC AGENT HCG BIOCOMPATIBLES U.K. LIMITED LC BEAD 70-150 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death LC BEAD WAS LOADED WITH DOXORUBICIN PRIOR TO USE