BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DC BEAD

    MDR report key: 4833738 · Received June 1, 2015

    Report

    Report Number
    3002124545-2015-00032
    Event Type
    Injury
    Date Received
    June 1, 2015
    Date of Event
    April 10, 2015
    Report Date
    May 7, 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

    NECROTIZING CHOLANGITIS (CHOLANGITIS]. CASE DESCRIPTION: INITIAL INFORMATION RECEIVED ON (B)(6)2015: THIS SPONTANEOUS CASE REPORT WAS RECEIVED FROM A PHYSICIAN VIA COMPANY DISTRIBUTOR AND IT CONCERNED A (B)(6) FEMALE PATIENT AFFECTED BY MULTIPLE HEPATOCELLULAR CARCINOMA (HCC). PATIENT'S PAST MEDICAL HISTORY INCLUDED: NEPHROSIS AND SPINAL STENOSIS. PATIENT'S CONCOMITANT DRUG WAS GELPART (POROUS GELATINE PARTICLES, 1MM). ON (B)(6) 2015, THE PATIENT UNDERWENT TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE) USING DRUG-ELUTING DC BEAD (100-300 MICROM) LOADED WITH 60 MG OF EPIRUBICIN HYDROCHLORIDE. DC BEAD LOADED WITH EPIRUBICIN (0.35 VIAL) WAS INJECTED INTO MULTIPLE HEPATOCELLULAR CARCINOMA (HCC) THROUGH THE RIGHT INFERIOR PHRENIC ARTERY. DC BEAD LOADED WITH EPIRUBICIN AND GELPART WAS INJECTED THROUGH DISTAL OF A5 (0.2 VIAL) AND THROUGH CHOLECYSTIC ARTERY (0.05 VIAL). ON (B)(6) 2015 PATIENT LABORATORY DATA WERE:TOTAL BILIRUBIN 0.7MG/DL (NORMAL RANGE: 0.2-1.0MG/DL), DIRECT BILIRUBIN 0.1MG/DL (NORMAL RANGE: 0.0-0.2 MG/DL), AST 27 IU/L (NORMAL RANGE: 10-35 IU/L), ALT 22IU/L (NORMAL RANGE: 5-40), LDH 274 IU/L (NORMAL RANGE: 120-240IU/L), AL-P 209IU/L (NORMAL RANGE 115-359IU/L), GAMMA-GT 54 IU/L (NORMAL RANGE: <30 IU/L), CK 95 IU/L (NORMAL RANGE 44-170 IU/L), WBC 6.10 10 3/MICROL (NORMAL RANGE: 4.00-9.00), AND CRP 0.22 MG/DL (NORMAL RANGE: <0.30). ON (B)(6) 2015, TOTAL BILIRUBIN WAS 1.2 MG/DL, DIRECT BILIRUBIN WAS 0.2 MG/DL, AST WAS 505 IU/L, ALT WAS 359 IU/L, LDH WAS 1376 IU/L, AL-P 317 IU/L, GAMMA-GT WAS 65 IU/L, WBC WAS 14.70 10 31MICROL AND CRP WAS 2.02 MG/DL. ON (B)(6) 2015, THE PATIENT PRESENTED NECROTIZING CHOLANGITIS DIAGNOSED ON CT-SCAN, WHICH REQUIRED HOSPITALISATION. PATIENT'S LABORATORY DATA ON (B)(6) 2015 WERE: TOTAL BILIRUBIN 1.6 MG/DL, DIRECT BILIRUBIN 0.4 MG/DL, AST 403 IU/L, ALT 370 IU/L, LDH 1034 IU/L, GAMMA-GT 71 IU/L, AL-P 316 IU/L, CK 690 IU/L, WBC 10.7 10A31MICROL, AND CRP 6.06 MG/DL. SINCE THE PATIENT PRESENTED A PHLEBOTHROMBOSIS OF LOWER EXTREMITIES AND RIGHT PULMONARY VENOUS THROMBUS, PERCUTANEOUS DRAINAGE UNDER CT SCAN WAS PERFORMED, WITHOUT CHOLECYSTECTOMY. MEROPENEM 3G PER DAY WAS ALSO GIVEN. NO PROGRESSION TO PERITONITIS WAS NOTED. ON (B)(6) 2015, NECROTIZING CHOLANGITIS WAS IMPROVING UNDER TREATMENT. THE PATIENT WAS IN RELATIVELY STABLE CONDITION. DECANNULATION WAS SCHEDULED. PATIENT'S LABORATORY DATA ON (B)(6) 2015 WERE: TOTAL BILIRUBIN: 1.0 MG/DL, DIRECT BILIRUBIN: 0.2 MG/DL, AST: 16 IU/L, ALT: 15 IU/L, LDH: 220 IU/L, GAMMA-GT: 98 IU/L, WBC 12.90 10 31MICROL AND CRP 4.47 MG/DL. (OTHER LABORATORY DATA REPORTED IN THE LABORATORY DATA SECTION). THE PHYSICIAN ASSESSED THE NECROTIZING CHOLANGITIS AS PROBABLY RELATED TO THE EMBOLIZATION OF CHOLECYSTIC ARTERY, AND THE PHLEBOTHROMBOSIS OF LOWER EXTREMITIES AND RIGHT PULMONARY V VENOUS THROMBUS AS NOT RELATED TO DCBEAD. CASE COMMENT: NECROTIZING CHOLANGITIS, PHLEBOTHROMBOSIS OF LOWER EXTREMITIES AND RIGHT PULMONARY VENOUS THROMBUS ARE CONSIDERED UNLISTED ACCORDING TO DC BEAD CURRENT INSTRUCTION FOR USE. THE PHYSICIAN CONSIDERED ONLY THE EVENT NECROTIZING CHOLANGITIS AS RELATED TO THE USE OF DC BEAD. 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.

    Description of Event or Problem · 1

    PHLEBOTHROMBOSIS OF LOWER EXTREMITIES (VENOUS THROMBOSIS). RIGHT PULMONARY VENOUS THROMBUS. F/U INFO RECEIVED ON 06/23/2015: INFO ON SALES DATA FOR DC BEAD WAS PROVIDED AND ADDED IN CASE COMMENT. CASE COMMENT: THE FIRST SALES FOR DC BEAD IN (B)(6) WERE IN 2004. SALES DATA FROM JANUARY 2010 FOR DC BEAD IS: (B)(4). THE FOLLOW-UP INFO RECEIVED ON 06/23/2015 DID NOT CHANGE THE CASE ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353789 DC BEAD HCG/KRD HCG BIOCOMPATIBLES UK LTD 100-300 MICROM

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization