BEUDAMED
    FDA Adverse Event Death Summary report: N

    DC BEAD

    MDR report key: 3952861 · Received July 17, 2014

    Report

    Report Number
    3002124545-2014-00017
    Event Type
    Death
    Date Received
    July 17, 2014
    Date of Event
    August 4, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    HCG
    PMA / PMN Number
    K094018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    DC BEAD WITH EPIRUBICIN WAS REPORTED TO HAVE BEEN USED IN THE TREATMENT OF THIS PATIENT. DC BEAD IS NOT INDICATED FOR USE WITH EPIRUBICIN. THE EQUIVALENT PRODUCT, LC BEAD, IS AVAILABLE IN THE USA AND IS INDICATED FOR THE TREATMENT OF HYPERVASCULAR TUMOURS AND AVMS. THE DEVICE HAS NOT BEEN SENT TO THE MANUFACTURER FOR EVALUATION. NO BATCH REVIEW WAS POSSIBLE FOR THIS CASE AS THE LOT NUMBER COULD NOT BE ASCERTAINED. NO PRODUCT MALFUNCTION/DEFICIENCY HAS BEEN IDENTIFIED. MEDICAL ASSESSMENT: PER REPORTED INFORMATION, THE PATIENT SUFFERED ELEVATED BILIRUBIN AFTER TACE PROCEDURE. FURTHER INFORMATION IS NEEDED, BUT THIS COULD REPRESENT LIVER FAILURE. THE FOLLOW-UP INFORMATION RECEIVED ON (B)(6) 2014 STATED: THE PATIENT'S AST, ALT, T-BIL, AND ALB IMPROVED OVER THE WEEK POST TACE, AND PATIENT WAS DISCHARGED FROM THE HOSPITAL. HOWEVER, DURING RECOVERY IMPROVEMENT SLOWED AND T-BIL WENT UP TO 7.4 MG/DL, SO THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL DUE TO POOR PROGNOSIS. DUE TO THE PATIENT BEING TRANSFERRED TO ANOTHER HOSPITAL THIS REPORT IS CONSERVATIVELY ASSESSED AS SERIOUS AND REPORTABLE.

    Description of Event or Problem · 1

    INITIAL AND FOLLOW-UP INFORMATION WAS RECEIVED FROM A USER FACILITY, VIA A PARTNER ORGANIZATION, ON THE (B)(6) 2014, RESPECTIVELY. IT WAS REPORTED THAT ON (B)(6) 2014, TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE) WAS PERFORMED ON A PATIENT WITH HEPATOCELLULAR CARCINOMA IN THE LIVER (S8 TO S4). THE PATIENT RECEIVED 3ML/20ML OF TEN-FOLD DILUTION OF DEVICE DC BEAD (BEAD SIZE: 100-300 UM) LOADED WITH EPIRUBICIN 50 MG. THE MIXTURE OF THE DC BEAD AND EPIRUBICIN 2 ML WAS INJECTED INTO THE SECOND BRANCH OF THE LEFT HEPATIC ARTERY. PATIENT AST, ALT, T-BIL AND ALB LEVELS IMPROVED WITHIN A WEEK AFTER THE TACE PROCEDURE - PATIENT WAS DISCHARGED. FOLLOW THIS, PATIENT T-BIL WENT UP TO 7.4 MG/DL AND PATIENT WAS HOSPITALIZED, "DUE TO POOR PROGNOSIS AND PROLONGATION." IT IS FURTHER REPORTED THAT BETWEEN (B)(6) 2014, PATIENT BILIRUBIN LEVELS INCREASED FROM 3.3 U/L TO 10 U/L. REPORT ALSO STATES THAT TACE WAS PERFORMED A TOTAL OF 15 TIMES ON PATIENT (WITH BILIRUBIN LEVELS INCREASING, BUT THEN RETURNING TO NORMAL LEVELS WITHIN A WEEK OR SO) AND A SMOOTH RECOVERY WAS MADE EACH TIME. FINAL PATIENT OUTCOME IS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419257 DC BEAD HCG/KRD HCG BIOCOMPATIBLES UK LTD 100-300 MICROM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Hospitalization| O| D DC BEAD LOADED WITH EPIRUBICIN 50MG PRIOR TO USE| DC BEAD LOADED WITH EPIRUBICIN 50MG PRIOR TO USE