BEUDAMED
    FDA Adverse Event Death Summary report: N

    DC BEAD

    MDR report key: 4360777 · Received December 1, 2014

    Report

    Report Number
    3002124545-2014-00033
    Event Type
    Death
    Date Received
    December 1, 2014
    Date of Event
    October 30, 2014
    Report Date
    November 27, 2014
    Manufacturer
    BIOCOMPATIBLES U.K. 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 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 TUMOURS AND AVM'S. THE USE OF EPIRUBICIN WITH DC BEAD IS CONSIDERED OFF-LABEL USE. THE DEVICE HAS NOT BEEN SENT TO THE MANUFACTURER FOR EVALUATION. BATCH REVIEW WILL NOT BE POSSIBLE FOR THIS CASE AS THE REPORTER DOES NOT SPECIFY LOT NUMBER. GIVEN THE CASE INFORMATION CURRENTLY AVAILABLE, IT IS DIFFICULT FOR THE MANUFACTURER TO ASSESS IF PRODUCT MALFUNCTION/DEFICIENCY HAS OCCURRED. MEDICAL ASSESSMENT: THIS PATIENT WITH ADVANCED CIRRHOSIS (CHILD'S C) AND HCC UNDERWENT DEB-TACE, WITHIN 48 HOURS HE DEVELOPED PULMONARY OEDEMA AND LATER DIED. A COMPLICATING FACTOR WAS THAT HE HAD ONLY ONE LUNG, PATIENT PREVIOUSLY UNDERGONE A PNEUMONECTOMY. THE REPORTER FELT THE EVENT WAS RELATED TO THE UNDERLYING DISEASE AND NOT TO DEB-TACE. HOWEVER, THE TEMPORAL RELATIONSHIP SUGGEST THAT THE PROCEDURE MAY HAVE ELIMINATED THE REMAINING LIVER FUNCTION IN A VERY ILL PATIENT. THIS COULD CONSTITUTE USER ERROR IN THE TREATMENT OF A PATIENT WITH TOO LITTLE HEPATIC RESERVE. ACCORDINGLY THIS EVENT IS REPORTABLE. THIS EVENT IS CURRENTLY UNDER INVESTIGATION BY THE MANUFACTURER AND THE CONCLUSIONS OF THIS INVESTIGATION WILL BE COMMUNICATED AS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THIS INITIAL REPORT CONCERNS AN (B)(6) YEAR OLD MALE PATIENT AND WAS RECEIVED FROM A USER FACILITY VIA A PARTNER ORGANIZATION ON (B)(6) 2014. PATIENT'S MEDICAL HISTORY INCLUDES (B)(6) (COMPLETE REMOVAL OF THE RIGHT LUNG). IT WAS UNKNOWN IF THE PATIENT RECEIVED ANY CONCOMITANT MEDICATION. PATIENT'S CONCOMITANT DISEASE INCLUDE: (B)(6), HYPERTENSION, PROSTATE CANCER AND ASCITES. ON (B)(6) 2014, THE PATIENT RECEIVED DC-BEAD (SIZE: 100-300 MICRONS; 90% OF DCB 100 TO 300 MICRON WAS LOADED WITH 30 MG EPIRUBICIN) FOR HEPATOCELLULAR CARCINOMA. SIXTY PERCENT WAS INJECTED INTO THE LEFT DIAPHRAGMATIC ARTERY. ON (B)(6) 2014, APPROXIMATELY TWO DAYS AFTER THE PROCEDURE, THE PATIENT'S RESPIRATORY STATUS GOT WORSE, AND THE PATIENT DEVELOPED PULMONARY OEDEMA. THE PATIENT RECEIVED AN UNSPECIFIED DIURETIC BUT THE PATIENT CONDITION DID NOT IMPROVE. ON (B)(6) 2014, AT 4:00 AM, THE PATIENT PASSED AWAY WITHOUT IMPROVEMENT. AT THE TIME OF THIS REPORT, IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. THE REPORTING PHYSICIAN STATED THAT THE PULMONARY OEDEMA WAS NOT RELATED TO DC BEAD. THE REPORTER ALSO STATED THAT "ALTHOUGH THE PATIENT HAD PREVIOUSLY UNDERGONE TACE MANY TIMES, HE SHOWED CHILD C AND PS 1 TO 2, WHICH MEANT BAD GENERAL CONDITION. THE PATIENT UNDERWENT DEB-TACE, WHICH WAS EXPECTED TO BE THE LAST PERFORMANCE. COMPLETE REMOVAL OF THE RIGHT LUNG AFFECTED THIS OUTCOME SIGNIFICANTLY, AND HE WAS NOT CONSIDERED TO BE TOLERANT OF RACE. CTACE WOULD HAVE RESULTED IN THE SAME OUTCOME", HENCE THE REPORTER FELT THAT THERE WAS NO CAUSAL RELATIONSHIP WITH DC BEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774445 DC BEAD EMBLIC AGENT HCG BIOCOMPATIBLES U.K. LTD. 100-300 MICRONS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death EPIRUBICIN 30 MG