BEUDAMED
    FDA Adverse Event Death Summary report: N

    DC BEAD

    MDR report key: 4911473 · Received July 10, 2015

    Report

    Report Number
    3002124545-2015-00046
    Event Type
    Death
    Date Received
    July 10, 2015
    Date of Event
    December 26, 2013
    Report Date
    July 1, 2015
    Manufacturer
    BIOCOMPATIBLES U.K. LIMITED
    Product Code
    HCG
    PMA / PMN Number
    K094018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DC BEAD WITH DOXORUBICIN 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 DEVICE HAS NOT BEEN SENT TO THE MFR FOR EVAL. NO BATCH REVIEW WAS POSSIBLE FOR THIS CASE AS THE LOT NUMBER COULD NOT BE ASCERTAINED. NO PRODUCT MALFUNCTION/DEFICIENCY HAS BEEN IDENTIFIED. LITERATURE DESCRIPTION: JOURNAL: THE SAUDI JOURNAL OF GASTROENTEROLOGY. AUTHOR: ARABI M, BENMOUSA A, BZEIZI K, GARAD F, AHMED I, AL-OTAIBI M. TITLE: DOXORUBICIN-LOADED DRUG-ELUTING BEADS VERSUS CONVENTIONAL TRANSARTERIAL CHEMOEMBOLIZATION FOR NONRESECTABLE HEPATOCELLULAR CARCINOMA. VOLUME: 21 (3). YEAR: 2015. PAGES: 175-180.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP INFORMATION RECEIVED ON JULY 14, 2015: RISK ASSESMENT AND DC BEAD SALES DATA IN (B)(6) WERE PROVIDED IN CASE COMMENTS. THIS CASE IS LINKED TO CASE (B)(4) (SAME PATIENT, OTHER BEADS SIZE) AND NOT (B)(4) AS REPORTED IN THE INITIAL VERSION CASE COMMENT: PANCREATITIS AND CHOLANGITIS ARE CONSIDERED UNLISTED AS PER DC BEAD INSTRUCTIONS FOR USE NON-TARGET EMBOLIZATION IS A POSSIBLE PROCEDURAL COMPLICATIONS REPORTED IN DC BEAD INSTRUCTIONS FOR USE. ADDITIONAL INFORMATION IS BEING SOUGHT AND WILL BE REPORTED AS A FOLLOW UP REPORT. RISK ASSESSMENT: THIS REPORT IS AN ADVERSE EVENT OF PANCREATITIS ATTRIBUTED TO NON-TARGET EMBOLIZATION. REPORTING OF THESE TYPES OF EVENTS ARE RARE. (B)(4) OTHER REPORTS OF NON-TARGET EMBOLIZATION HAVE BEEN RECEIVED FOR DC BEAD IN AN ESTIMATED (B)(4) PATIENT TREATMENTS. THIS IS A REPORTING RATE OF (B)(4)% MOREOVER NON-TARGET EMBOLIZATION IS A KNOWN RISK OF THE PROCEDURE AND IS DOCUMENTED IN THE PRODUCT IFU THEREFORE AT THIS TIME THE CASE REPORT DOES NOT REPRESENT A CHANGE TO THE ESTABLISHED BENEFIT RISK PROFILE OF THE PRODUCT.

    Additional Manufacturer Narrative · 1

    DC BEAD WITH DOXORUBICIN HYDROCHLORIDE WAS REPORTED TO HAVE BEEN USED IN THE TREATMENT OF THIS PATIENT. THE EQUIVALENT PRODUCT I.C. BEAD IS AVAILABLE IN THE USA AND IS INDICATED FOR THE TREATMENT OF HYPERVASCULAR TUMORS AND AVMS. THE DEVICE HAS NOT BEEN SENT TO THE MANUFACTURER FOR EVALUATION. NO BATCH REVIEW WAS POSSIBLE OF THIS CASE AS THE LOT NUMBER COULD NOT BE ASCERTAINED. NO PRODUCT MALFUNCTION/DEFICIENCY HAS BEEN IDENTIFIED.

    Description of Event or Problem · 1

    PANCREATITIS [PANCREATITIS]. FOCAL SEGMENTAL CHOLANGITIS [CHOLANGITIS]. NON TARGET EMBOLIZATION [PROCEDURAL COMPLICATION]. CASE DESCRIPTION: INITIAL INFORMATION REC'D ON 01-JUL-2015: THIS LITERATURE CASE REPORT WAS PUBLISHED IN THE SAUDI JOURNAL OF GASTROENTEROLOGY, BY ARABI M ET AL, WITH THE TITLE "DOXORUBICIN-LOADED DRUG-ELUTING BEADS VERSUS CONVENTION TRANSARTERIAL CHEMOEMBOLIZATION FOR NONRESECTABLE HEPATOCELLULAR CARCINOMA" AND IT CONCERNED A PATIENT OF UNSPECIFIED AGE AND GENDER AFFECTED BY HEPATOCARCINOMA (HCC) INCLUDED IN A RETROSPECTIVE STUDY OF 54 PATIENTS. THE PATIENT HAD PRE- AND POST-CLINICAL AND LABORATORY EVAL AS WELL AS CROSS-SECTIONAL IMAGING WITH TRIPHASIC COMPUTED TOMOGRAPHY (CT) OR MAGNETIC RESONANCE (MR) OF THE LIVER PRIOR TO AND FOLLOWING THE PROCEDURE TO ASSESS FOR TUMOR RESPONSE. ON AN UNSPECIFIED DATE, THE PATIENT WAS TREATED BY DRUG ELUTING BEADS TRANSARTERIAL CHEMOTHERAPY (DEB-TACE) THROUGH FEMORAL ARTERY APPROACH. THE DEB-TACE PROTOCOL USED DC BEADS 100-300 MICROM AND DC BEAD 300-500 MICROM, BOTH LOADED WITH 75 MG OF DOXORUBICIN HYDROCHLORIDE. ON AN UNSPECIFIED DATE AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH PANCREATITIS, WHICH WAS ATTRIBUTED TO NON-TARGET EMBOLIZATION. THIS RESULTED IN A 5 CM PANCREATIC HEAD PSEUDOCYST AND LATER OBSTRUCTIVE JAUNDICE AND FOCAL SEGMENTAL CHOLANGITIS. OUTCOME OF THE EVENTS WAS NOT REPORTED. THE AUTHORS ASSESSED THE EVENTS AS RELATED TO NON-TARGET EMBOLIZATION BUT DID NOT REPORT ANY SERIOUSNESS CRITERIA. UPON REVIEW, THE COMPANY ASSESSED THE EVENTS AS POSSIBLY RELATED TO DC BEAD AS SERIOUS (MEDICALLY SIGNIFICANT). THIS CASE IS LINKED TO CASE (B)(6) (SAME PATIENT, OTHER BEADS SIZE). CASE COMMENT: PANCREATITIS AND CHOLANGITIS ARE CONSIDERED UNLISTED AS PER DC BEAD INSTRUCTIONS FOR USE. NONTARGET EMBOLIZATION IS A POSSIBLE PROCEDURAL COMPLICATION REPORTED IN DC BEAD INSTRUCTIONS FOR USE. THE COMPANY CONSIDERED THE EVENTS DUE TO THE NON-TARGET EMBOLIZATION RELATED TO DC BEAD THERAPY AS A CONSEQUENCE OF USER ERROR. THIS SINGLE CASE REPORT DOES NOT MODIFY THE RISK BENEFIT BALANCE OF DC BEAD. THE COMPANY IS CONTINUOUSLY MONITORING ALL RESPECTIVE REPORTS REC'D, AND BASED ON CUMULATIVE EXPERIENCE, WILL RE-EVALUATE THE AVAILABLE EVIDENCE ON AN ONGOING BASIS. THE FIRST SALES FOR DC BEAD IN (B)(6)WERE IN 2004. (B)(4).

    Description of Event or Problem · 1

    NECROTISING PANCREATITIS (PANCREATITIS NECROTISING] FOCAL SEGMENTAL CHOLANGITIS [CHOLANGITIS]. CLOSTRIDIUM DEFICILE INFECTION [CLOSTRIDIUM DIFFICILE INFECTION] NON TARGET EMBOLIZATION [PROCEDURAL COMPLICATION] DETERIORATION OF LIVER FUNCTION/DECOMPENSATION OF HER KNOWN CHRONIC LIVER DISEASE [CONDITION AGGRAVATED]. CASE DESCRIPTION: INITIAL INFORMATION RECEIVED ON 01-JUL-2015: THIS LITERATURE CASE REPORT WAS PUBLISHED IN THE SAUDI JOURNAL OF GASTROENTEROLOGY, BY ARABI M. ET AL, WITH THE TITLE "DOXORUBICIN-LOADED DRUG-ELUTING BEADS VERSUS CONVENTIONAL TRANSARTERIAL CHEMOEMBOLIZATION FOR NONRESECTABLEHEPATOCELLULAR CARCINOMA" AND IT CONCERNED A PATIENT OF UNSPECIFIED AGE AND GENDER AFFECTED BY HEPATOCARCINOMA (HCC) INCLUDED IN A RETROSPECTIVE STUDY OF 54 PATIENTS. THE PATIENT HAD PRE- AND POSTCLINICAL AND LABORATORY EVALUATION AS WELL AS CROSS-SECTIONAL IMAGING WITH TRIPHASIC COMPUTED TOMOGRAPHY (CT) OR MAGNETIC RESONANCE (MR) OF THE LIVER PRIOR TO AND FOLLOWING THE PROCEDURE TO ASSESS FOR TUMOR RESPONSE. ON AN UNSPECIFIED DATE, THE PATIENT WAS TREATED BY DRUG ELUTING BEADS TRANSARTERIAL CHEMOTHERAPY (DEB-TACE) THROUGH FEMORAL ARTERY APPROACH. THE DEB-TACE PROTOCOL USED DC BEADS 100-300 MICROM AND DC BEAD 300-500 MICROM, BOTH LOADED WITH 75 MG OF DOXORUBICIN HYDROCHLORIDE. ON AN UNSPECIFIED DATE AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH PANCREATITIS, WHICH WAS ATTRIBUTED TO NON-TARGET EMBOLIZATION. THIS RESULTED IN A 5 CM PANCREATIC HEAD PSEUDOCYST AND LATER OBSTRUCTIVE JAUNDICE AND FOCAL SEGMENTAL CHOLANGITIS. OUTCOME OF THE EVENTS WAS NOT REPORTED. THE AUTHORS ASSESSED THE EVENTS AS RELATED TO NON-TARGET EMBOLIZATION BUT DID NOT REPORTED ANY SERIOUSNESS CRITERIA. UPON REVIEW, THE COMPANY ASSESSED THE EVENTS AS POSSIBLY RELATED TO DC BEAD AND AS SERIOUS (MEDICALLY SIGNIFICANT). THIS CASE IS LINKED TO CASE (B)(4) (SAME PATIENT, OTHER BEADS SIZE). FOLLOW-UP INFORMATION RECEIVED ON 14-JUL-2015: RISK ASSESMENT AND DC BEAD SALES DATA IN (B)(4) WERE PROVIDED IN CASE COMMENTS. THIS CASE IS LINKED TO CASE (B)(4) (SAME PATIENT, OTHER BEADS SIZE) AND NOT (B)(4) AS REPORTED IN THE INITIAL VERSION. ADDITIONAL INFORMATION RECEIVED ON 31-AUG-2015: PATIENT'S RELEVANT MEDICAL HISTORY WAS PROVIDED. THE PATIENT SUFFERED OF (B)(6) INDUCED LIVER CIRRHOSIS, SHE WAS DIABETIC ON TREATMENT; ON (B)(6) 2011 SHE PRESENTED AN OBSTRUCTIVE JAUNDICE. SHE HAD A PREVIOUS EPISODE OF ACUTE NECROTIZING PANCREATITIS INVOLVING THE TAIL. ON (B)(6) 2012 THE PATIENT HAD A LAPAROSCOPIC CHOLECYSTECTOMY. CONCOMITANT MEDICATIONS WERE: ENTECAVIR 0.5MG DAILY; METFORMIN 500MG BID; GLICLAZIDE 60MG DAILY, FOSINOPRIL 30MG DAILY, AMLODIPINE 5MG DAILY, LACTULOSE 30ML BID, PANTOPRAZOLE 40MG DAILY, MULTIVITAMIN 1TAB DAILY. THE PATIENT UNDERWENT DC BEAD-TACE ON (B)(6) 2013. SHE PRESENTED THE PANCREATITIS ON (B)(6) 2013 DIAGNOSED AT FOLLOW UP CT. THE PATIENT DEVELOPED NECROTIZING PANCREATITIS OF THE PANCREATIC HEAD WITH SECONDARY PSEUDOCYST FOMIATION AND LATER OBSTRUCTIVE JAUNDICE AND FOCAL SEGMENTAL CHOLANGITIS. THIS REQUIRED PROLONGED HOSPITALIZATION. LATER SHE DEVELOPED MULTIPLE INFECTIONS IMPORTANTLY CLOSTRIDIUM DIFFICILE INFECTION (DUE TO PROLONGED COURSE OF ANTIBIOTICS) AND THAT RESULTED IN DECOMPENSATION OF HER KNOWN CHRONIC LIVER DISEASE. THE PATIENT PASSED AWAY ON (B)(6) 2014. THE REPORTER CONFIRMED THAT THE PANCREATITIS WAS SERIOUS SINCE IT CAUSED PROLONGED HOSPITALIZATION AND POSSIBLY CONTRIBUTED TO DETERIORATION OF THE LIVER FUNCTION TOGETHER WITH HOSPITAL ACQUIRED INFECTION. THE REPORTER STATED THAT IT WAS PROBABLE THAT THE PANCREATITIS WAS RELATED TO ADMINISTRATION OF DC BEAD DUE TO THE TEMPORAL RELATION. HOWEVER SOME OTHER FACTORS HAD TO BE CONSIDERED IN THIS CASE, FIRST THE PATIENT HAD A HISTORY OF NECROTIZING PANCREATITIS EARLIER, WHICH MAY MAKE HER PRONE TO RECURRENT ATTACK. SECOND, THE PATIENT HAD A REPLACED RIGHT HEPATIC ARTERY, WHICH WAS CO-AXIALLY CANNULATED USING MICROCATHETER. WHILE INFUSION OF DC BEADS WAS IN A SUPERSELECTIVE POSITION, THE LIKELIHOOD OF NON-TARGET EMBOLIZATION REMAINS POSSIBLE DUE TO SMALL COMMUNICATION WITH PANCREATIC BRANCHES THAT WAS NOT IDENTIFIED ON THE ANGIOGRAPHY. ON 26-NOV-2015: THIS CASE IS A DUPLICATE OF CASE (B)(4), AS CONSEQUENCE IT IS NULLIFIED. CASE COMMENT: THE FOLLOW UP INFORMATION RECEIVED DOES NOT MODIFY THE ASSESSMENT OF THE CASE. HOWEVER SOME OTHER FACTORS THAT COULD HAVE CONTRIBUTED TO THE OCCURRENCE OF PANCREATITIS WERE PROVIDED. AS PER REPORTER, THE PATIENT MEDICAL HISTORY OF NECROTIZING PANCREATITIS COULD HAVE MAKE THE PATIENT MORE SUSCEPTIBLE TO THE DISEASE AND THE NON-TARGET EMBOLIZATION REMAINS POSSIBLY DUE TO SMALL COMMUNICATION WITH PANCREATIC BRANCHES. PROCEDURAL COMPLICATION REPORTED IN DC BEAD INSTRUCTIONS FOR USE. THE COMPANY CONSIDERED THE EVENTS DUE TO THE NON-TARGET EMBOFIZATION RELATED TO DC BEAD THERAPY AS A CONSEQUENCE OF USER ERROR. 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. THE FIRST SALES FOR DC BEAD IN THE (B)(4) WERE IN 2004. SALES DATA FROM JAN-2010 FOR DC BEAD IS: EU 116.815 VIALS AND ROW 59.919 VIALS. RISK ASSESSMENT: THIS REPORT IS AN ADVERSE EVENT OF PANCREATITIS ATTRIBUTED TO NON-TARGET EMBOLISATION. REPORTING OF THESE TYPES OF EVENTS ARE RARE. 12 OTHER REPORTS OF NON-TARGET EMBOLISATION HAVE BEEN RECEIVED FOR DC BEAD IN AN ESTIMATED 149,131 PATIENT TREATMENTS. THIS IS A REPORTING RATE OF (B)(4) MOREOVER NON-TARGET EMBOLISATION IS A KNOWN RISK OF THE PROCEDURE AND IS DOCUMENTED IN THE PRODUCT IFU. THEREFORE AT THIS TIME THE CASE REPORT DOES NOT REPRESENT A CHANGE TO THE ESTABLISHED BENEFIT RISK PROFILE OF THE PRODUCT. FINAL CASE ASSESSMENT 27 NOV 2015: THIS CASE IS A DUPLICATE OF CASE (B)(4), AS CONSEQUENCE IT IS NULLIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448888 DC BEAD HCG BIOCOMPATIBLES U.K. LIMITED 300-500 MICROM

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H| O