BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DC BEAD

    MDR report key: 7185643 · Received January 12, 2018

    Report

    Report Number
    3002124543-2018-00001
    Event Type
    Injury
    Date Received
    January 12, 2018
    Date of Event
    September 3, 2014
    Report Date
    December 28, 2017
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    KRD
    PMA / PMN Number
    K094018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DC BEAD WITH EPIRUBICIN HYDROCHLORIDE WAS REPORTED TO HAVE BEEN USED IN THE TREATMENT OF THIS PATIENT. THE EQUIVALENT PRODUCT LC BEAD IS AVAILABLE IN THE US AND IS INDICATED FOR THE TREATMENT OF HYPERVASCULAR TUMORS AND AVMS. DC BEAD WITH EPIRUBICIN IS CONSIDERED OFF-LABEL USE. ABDOMINAL PAIN, INCREASED HEPATOBILIARY ENZYMES AND HEPATIC INFARCTION ARE ANTICIPATED ADVERSE EVENTS ASSOCIATED WITH DC BEAD. ABDOMINAL PAIN AND INCREASED HEPATOBILIARY ENZYMES ARE NON SERIOUS EVENTS. HEPATIC INFARCTION IS A SERIOUS EVENT THAT REQUIRED HOSPITALIZATION. THE PHYSICIAN REPORTED THAT THE EVENT DEVELOPED IN THE EARLY STAGE OF THE TREATMENT AND A POSSIBILITY OF INSUFFICIENT DILUTION COULD NOT BE RULED OUT. THE PHYSICIAN'S PROCESS FOR DILUTION WAS NOT REPORTED. THE PRODUCT IFU DOES NOT DIRECT DEVICE DILUTION BEYOND THE USE OF A CONTRAST AGENT, THEREFORE, WITHOUT FURTHER DETAIL FROM THE REPORTING PHYSICIAN, IT IS UNKNOWN WHAT ROLE THE DILUTION PLAYED IN THE ADVERSE EVENT. THE EVENT WAS ASSESSED BY A BTG PHYSICIAN AND THE EFFECTS OF EMBOLIZATION USUALLY OCCUR WITHIN THE FIRST WEEK AFTER TREATMENT, WHILE THESE EVENTS OCCURRED GREATER THAN 30 DAYS AFTER DEVICE IMPLANTATION. THEREFORE, DUE TO A LACK OF INFORMATION, BTG IS REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION. EPIRUBICIN COULD HAVE FAVORED THE OCCURRENCE OF THE ADVERSE EVENT BUT IS NOT THE CAUSALITY. NO BATCH REVIEW WAS POSSIBLE FOR THIS CASE AS THE LOT NUMBER COULD NOT BE ASCERTAINED. NO PRODUCT MALFUNCTION/DEFICIENCY HAS BEEN IDENTIFIED. FOLLOW UP INFORMATION WAS REQUESTED, BUT THE INFORMATION PROVIDED TO BTG DID NOT CONTAIN ANY RELEVANT INFORMATION. SHOULD WE RECEIVE ANY INFORMATION TO ENABLE FURTHER INVESTIGATIONS, A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME, THIS REPORT IS CONSIDERED FINAL.

    Description of Event or Problem · 1

    ON (B)(6) 2014, AN (B)(6) MALE WITH A HISTORY OF RIGHT LUNG CANCER AND ANGINA PECTORIS WAS TREATED FOR HCC WITH TACE IN HEPATIC ARTERY A3 (INFERIOR BRANCH OF THE LEFT HEPATIC ARTERY) WITH A 10-FOLD DILUTION OF DC BEAD (100-300 MICROM) 1.6 ML LOADED WITH 50 MG OF EPIRUBICIN HYDROCHLORIDE (OFF-LABEL USE). CONCOMITANT DRUGS REPORTED: EPIRUBICIN HYDROCHLORIDE, HYDROCORTISONE SODIUM SUCCINATE. ON (B)(6) 2014, THE PATIENT PRESENTED WITH UPPER ABDOMINAL PAIN AND INCREASED HEPATOBILIARY ENZYMES. COMPUTED TOMOGRAPHY (CT) SHOWED HEPATIC INFARCTION IN THE S4 SEGMENT (UNTREATED SEGMENT). FLUID REPLACEMENT AND ANTIBIOTIC THERAPY WITH SULTAMUGIN (CEFOPERAZONE SODIUM/SULBACTAM SODIUM) 2G/DAY WERE STARTED ON THE SAME DAY. ON (B)(6) 2014, THE ABDOMINAL PAIN IMPROVED. IMPROVEMENT IN THE HEPATOBILIARY ENZYMES AND INFLAMMATORY REACTION WAS NOTED ON CT. THE ANTIBIOTIC THERAPY WAS DISCONTINUED ON (B)(6) 2014 AND THE PATIENT RECOVERED FROM THE HEPATIC INFARCTION AND WAS DISCHARGED ON (B)(6) 2014. THE DURATION OF HOSPITALIZATION WAS NOT REPORTED. THE PHYSICIAN REPORTED THAT THE EVENT DEVELOPED IN THE EARLY STAGE OF THE TREATMENT AND A POSSIBILITY OF INSUFFICIENT DILUTION COULD NOT BE RULED OUT. THE PHYSICIAN ASSESSED HEPATIC INFARCTION AS PROBABLY RELATED TO DC BEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30850 DC BEAD SINGLE USE IMPLANTABLE MEDICAL DEVICE KRD BIOCOMPATIBLES UK LTD 100-300 MICROM

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization THE 50 MG OF EPIRUBICIN HYDROCHLORIDE