BEUDAMED
    FDA Adverse Event Death Summary report: N

    DC BEAD

    MDR report key: 4833602 · Received May 22, 2015

    Report

    Report Number
    3002124545-2015-00029
    Event Type
    Death
    Date Received
    May 22, 2015
    Date of Event
    April 9, 2015
    Report Date
    April 28, 2015
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    HCG
    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 USA AND IS INDICATED FOR THE TREATMENT OF HYPERVASCULAR TUMORS AND AVMS. THE USE OF DC BEAD WITH EPIRUBICIN HYDROCHLORIDE IS CONSIDERED OFF-LABEL USE. 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.

    Description of Event or Problem · 1

    SEPSIS [SEPSIS], LIVER ABSCESS [LIVER ABSCESS], BACTERASCITES [BACTERASCITES], PERITONITIS [PERITONITIS], PYREXIA [PYREXIA]. CASE DESCRIPTION: INITIAL INFORMATION RECEIVED ON (B)(6) 2015: THIS SPONTANEOUS MEDICAL DEVICE REPORT WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA THE COMPANY DISTRIBUTOR, CONCERNING A (B)(6) PATIENT (GENDER UNSPECIFIED). PATIENT'S CONCOMITANT DISEASE INCLUDED (B)(6) AND GASTROOESOPHAGEAL VARICES. PATIENT'S MEDICAL HISTORY INCLUDED ALLERGIC PREDISPOSITION TO CISPLATIN AND LIPIODOL (IODINE ADDITION PRODUCTS OF THE ETHYLESTERS OF THE FATTY ACIDS OBTAINED FROM POPPYSEED OIL, HISTORY OF ADVERSE DRUG REACTIONS TO CISPLATIN AND LIPIODOL. THE PATIENT WAS TAKING THE FOLLOWING CONCOMITANT DRUGS: LACTULOSE, FUROSEMIDE, OMEPRAZOLE, ENTECAVIR HYDRATE, EPIRUBICIN HYDROCHLORIDE. ON (B)(6) 2015, THE PATIENT UNDERWENT TACE PERFORMED WITH DC BEAD (BEAD SIZE UNSPECIFIED) (LOT NUMBER AND EXPIRATION DATE NOT REPORTED) LOADED WITH EPIRUBICIN HYDROCHLORIDE (INDICATION NOT SPECIFIED). THE PATIENT DEVELOPED PYREXIA AFTER TACE WITH DC-BEAD. ON (B)(6)2015, THE PATIENT DEVELOPED SEPSIS. ON (B)(6) 2015, THE PATIENT DEVELOPED LIVER ABSCESS AND BACTERASCITES ASSOCIATED WITH PERITONITIS. ON (B)(6) 2015, THE PATIENT PASSED AWAY. PYREXIA, SEPSIS, LIVER ABSCESS, BACTERASCITES, AND PERITONITIS WERE CONSIDERED BY THE REPORTER AS THE CAUSES OF DEATH. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. THE REPORTER ASSESSED ALL THE EVENTS AS POSSIBLY RELATED TO DC-BEAD THERAPY. THE CAUSES OF DEATH REPORTED BY THE PHYSICIAN WAS LIVER ABSCESS AND BACTERASCITES ASSOCIATED WITH PERITONITIS. CASE COMMENT: PYREXIA, SEPSIS, LIVER ABSCESS, BACTERASCITES, AND PERITONITIS ARE CONSIDERED UNLISTED ACCORDING TO DC BEAD CURRENT INSTRUCTION FOR USE. THE PHYSICIAN CONSIDERED THE EVENTS AS POSSIBLY RELATED TO THE USE OF DC BEAD. THE COMPANY CONSIDERED ALSO THE EVENTS EXPERIENCED BY THE PATIENT AS RELATED, AS ITS ROLE CANNOT BE EXCLUDED. MOREOVER, EVEN IF THE EVENTS (PYREXIA, SEPSIS, LIVER ABSCESS, BACTERASCITES, AND PERITONITIS) ARE CONSIDERED UNLISTED, DEATH AND INFECTIONS ARE CONSIDERED LISTED ACCORDING TO DC BEAD CURRENT INSTRUCTION FOR USE. THIS SINGLE CASE REPORT DOES NOT MODIFY THE RISK BENEFIT BALANCE OF DC BEAD. THE COMPANY IS CONTINUOUSLY MONITORING ALL RESPECTIVE REPORTS RECEIVED, AND BASED ON CUMULATIVE EXPERIENCE, WILL RE-EVALUATE THE AVAILABLE EVIDENCE ON AN ONGOING BASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337733 DC BEAD HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE HCG BIOCOMPATIBLES UK LTD 100-300 MICROM

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death OMERPRAZOLE| EPIRUBICIN HYDROCHLORIDE| LACTULOSE| FUROSEMIDE| ENTECAVIR