BEUDAMED
    FDA Adverse Event Other Summary report: N

    DC BEAD

    MDR report key: 4927769 · Received July 17, 2015

    Report

    Report Number
    3002124545-2015-00047
    Event Type
    Other
    Date Received
    July 17, 2015
    Date of Event
    May 11, 2015
    Report Date
    July 6, 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

    CASE COMMENT: LIVER ABSCESS IS UNLISTED ACCORDING TO THE CURRENT DC BEAD INSTRUCTION FOR USE. ALTHOUGH THE LIMITED INFORMATION REPORTED FOR THIS CASE, THE COMPANY ASSESSED THE EVENT LIVER ABSCESS AS RELATED TO DC BEAD, SINCE ITS ROLE CANNOT BE EXCLUDED. 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 REEVALUATE THE AVAILABLE EVIDENCE ON AN ONGOING BASIS. 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 TUMORS AND AVMS.

    Additional Manufacturer Narrative · 1

    THE REPORTING PHYSICIAN COMMENTED THAT THE SITE OF LOW-DENSITY AREA (LDA) DIFFERENT FROM THE POST-TREATMENT SITE AND THE SITE OF CHOLEDOCHOJEJUNOSTOMY WERE CONSIDERED TO BE RELATED TO EACH OTHER. FOR THE SITE OF BILOMA AND THE SITE OF LDA, THEY WERE NEAR BUT THE RELATIONSHIP BETWEEN THEM WAS UNKNOWN. CASE COMMENT: LIVER ABSCESS AND BILOMA ARE UNLISTED ACCORDING TO THE CURRENT DC BEAD INSTRUCTION FOR USE. THE COMPANY ASSESSED THE EVENTS LIVER ABSCESS AND BILOMA AS RELATED TO DC BEAD, SINCE ITS ROLE CANNOT BE EXCLUDED. AS MENTIONED BY THE AUTHOR, PATIENT'S MEDICAL HISTORY COULD ALSO HAVE CONTRIBUTED TO THE OCCURRENCE OF THE EVENTS. THE FOLLOW-UP INFORMATION RECEIVED ON JULY 31, 2015, DOES NOT CHANGE THE ASSESSMENT OF THE CASE.

    Additional Manufacturer Narrative · 1

    DC BEAD WITH EPIRUBICIN 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 IS CONSIDERED OFF-LABEL USE.

    Additional Manufacturer Narrative · 1

    THE USE OF DC BEAD WITH EPIRUBICIN IS CONSIDERED OFF-LABEL USE AS MENTIONED BY THE AUTHOR. PATIENT'S MEDICAL HISTORY COULD ALSO HAVE CONTRIBUTED TO THE OCCURRENCE OF THE EVENT LIVER ABSCESS. WITH RECEIPT OF THE FOLLOW-UP INFORMATION RECEIVED ON JULY 16, 2015, THE CASE ASSESSMENT WAS SLIGHTLY CHANGED. THE FIRST SALES FOR DC BEAD IN (B)(4) WERE IN 2004. (B)(4).

    Description of Event or Problem · 1

    LIVER ABSCESS. CASE DESCRIPTION: INITIAL INFORMATION RECEIVED ON 07/06/2015: THIS MEDICAL DEVICE REPORT WAS RECEIVED BY A PHYSICIAN VIA COMPANY DISTRIBUTOR AND IT CONCERNED A PATIENT OF UNSPECIFIED AGE AND GENDER. PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE PATIENT UNDERWENT TRANSCATHETER CHEMOEMBOLIZATION (TACE) USING DRUG-ELUTING DC BEAD (BEAD SIZE AND DRUG USED NOT REPORTED). ON AN UNSPECIFIED DATE AFTER DEB-TACE PROCEDURE, THE PATIENT DEVELOPED LIVER ABSCESS. MULTIPLE ABSCESSES WERE OBSERVED IN THE LIVER AREA WERE THE DC BEADS NOT INJECTED. ON AN UNKNOWN DATE, LIVER ABSCESS WAS NOT RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE REPORTING PHYSICIAN CONSIDERED THE LIVER ABSCESS AS POSSIBLY RELATED TO DC BEAD, BUT DID NOT PROVIDE ANY SERIOUSNESS CRITERIA. UPON REVIEW, THE COMPANY ASSESSED THE EVENT AS SERIOUS (MEDICALLY SIGNIFICANT).

    Description of Event or Problem · 1

    BILOMA DEVELOPED [BILOMA]. FOLLOW-UP INFORMATION RECEIVED ON JULY 31, 2015: ON (B)(6) 2015, THE PATIENT RECEIVED DC BEAD TACE PROCEDURE FOR THE TREATMENT OF HCC, THE DRUG-ELUTING BEAD WAS DILUTED IN 20ML CONTRAST MATERIAL AND 12,5ML OF THIS WAS USED FOR S7 PERIPHERAL AND 4 ML FOR S6 SUBSEGMENT. ON (B)(6) 2015 THE PATIENT DEVELOPED A BILOMA. THE PTBD CATHETER WAS PLACED ON (B)(6) 2015 THE PTBD CATHETER WAS CHANGED TO INTERNAL DRAINAGE. ON (B)(6) 2015 THE PTBD CATHETER WAS PLACED AGAIN. ON (B)(6) 2015 THE LIVER ABSCESS HAD RECOVERED AND THE PATIENT WAS DISCHARGED. ON AN UNKNOWN DATE, THE PATIENT WAS ADMINISTERED FOR TREATMENT: SULPERAZON (CEFOPERAZONE SODIUM/SULBACTAM SODIUM); ZOSYN (TAZOBACTAM SODIUM/PIPERACILLIN SODIUM); AND MEROPEN (MEROPENEM HYDRATE).

    Description of Event or Problem · 1

    LIVER ABSCESS [LIVER ABSCESS] BILOMA DEVELOPED [BILOMA] CASE DESCRIPTION: INITIAL INFORMATION RECEIVED ON 06-JUL-2015: THIS MEDICAL DEVICE REPORT WAS RECEIVED BY A PHYSICIAN VIA COMPANY DISTRIBUTOR AND IT CONCERNED A PATIENT OF UNSPECIFIED AGE AND GENDER. PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE PATIENT UNDERWENT TRANSCATHETER CHEMOEMBOLIZATION (TACE) USING DRUG-ELUTING DC BEAD (BEAD SIZE AND DRUG USED NOT REPORTED). ON AN UNSPECIFIED DATE AFTER DEB-TACE PROCEDURE, THE PATIENT DEVELOPED LIVER ABSCESS. MULTIPLES ABSCESSES WERE OBSERVED IN THE LIVER AREA WERE THE DC BEADS WERE NOT INJECTED. ON AN UNKNOWN DATE, LIVER ABSCESS WAS NOT RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE REPORTING PHYSICIAN CONSIDERED THE LIVER ABSCESS AS POSSIBLY RELATED TO DC BEAD, BUT DID NOT PROVIDE ANY SERIOUSNESS CRITERIA. UPON REVIEW, THE COMPANY ASSESSED THE EVENT AS SERIOUS (MEDICALLY SIGNIFICANT). FOLLOW-UP INFORMATION RECEIVED ON 16-JUL-2015: ADDITIONAL INFORMATION WERE PROVIDED BY THE PHYSICIAN WHO INITIALLY REPORTED THE CASE. THE PATIENT WAS A (B)(6) MALE PATIENT. PATIENT'S MEDICAL HISTORY WAS REPORTED AS HEPATOCELLULAR CARCINOMA (3 OR MORE TUMORS, MAXIMUM TUMOR DIAMETER: 35MM), BILIARY DISEASE OBSTRUCTION AFTER CHOLEDOCHOJEJUNONOSTOMY. ADDITIONAL INFORMATION ON TACE PROCEDURE WAS PROVIDED: ON AN UNKNOWN DATE, ONE SINGLE TACE WAS PERFORMED USING ONE VIAL OF DCBEAD (100-300 MICROM), LOADED WITH EPIRUBICIN 40 MG. THE DEGREE OF EMBOLIZATION WAS SLOW (FOR THE DISAPPEARANCE RATE OF CONTRAST MEDIUM, 5 HEARTBEATS AFTER CONTRACT MEDIUM INJECTION WERE USED AS A REFERENCE). THE EMBOLIZATION SITES WERE S7 PERIPHERAL AND S6 SUBSEGMENT. ON AN UNKNOWN DATE, CT FINDINGS SHOWED BILOMA (BILIARY CYST), BUT IT WAS UNKNOWN IF THE PATIENT HAD IT BEFORE THE DEVELOPMENT OF LIVER ABSCESS. ON (B)(6) 2015: ADRIAMYCIN WAS ADMINISTERED TO INTRODUCE NEXAVAR (SORAFENIB TOSILATE), AFTER TACE. IN THE LIVER, IN ADDITION TO THE SITE POSSIBLY WITH A POST-TREATMENT CHANGE, MULTIPLE LOW-DENSITY AREAS (LDAS) WERE SEEN. TO THE LDA DIFFERENT FROM THE POST-TREATMENT SITE, PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) CATHETER WAS INSERTED IN TREE SITES, BUT IT RESULTED IN POOR CONTROL. AT THE TIME OF REPORTING, THE PATIENT WAS BEING TREATED AND THE EVENT WAS NOT RESOLVED. OF THE ABOVE SURVEY ITEMS, THE FACTORS THAT MAY HAVE BEEN THE POSSIBLE CAUSES OF THE DEVELOPMENT OF LIVER ABSCESS WERE THE UNDERLYING DISEASE (HCC), THE PAST HISTORY OF BILIARY DISEASE OBSTRUCTION AFTER CHOLEDOCHOJEJUNOSTOMY BUT THE REPORTING ALSO STATED THAT LIVER ABSCESS IS POSSIBLY RELATED TO DC BEAD. FOLLOW-UP INFORMATION RECEIVED ON 31-JUL-2015: ON (B)(6) 2015, THE PATIENT RECEIVED DC BEAD_TACE PROCEDURE FOR THE TREATMENT OF HCC, THE DRUG-ELUTING BEAD WAS DILUTED IN 20ML CONTRAST MATERIAL AND 12,5ML OF THIS WAS USED FOR S7 PERIPHERAL AND 4 ML FOR S6 SUBSEGMENT. ON (B)(6) 2015 THE PATIENT DEVELOPED A BILOMA. THE PTBD CATHETER WAS PLACED ON (B)(6) 2015. ON (B)(6) 2015 THE PTBD CATHETER WAS CHANGED TO INTERNAL DRAINAGE. ON (B)(6) 2015 THE PTBD CATHETER WAS PLACED AGAIN. ON (B)(6) 2015 THE LIVER ABSCESS HAD RECOVERED AND THE PATIENT WAS DISCHARGED. ON AN UNKNOWN DATE, THE PATIENT WAS ADMINISTERED FOR TREATMENT: SULPERAZON (CEFOPERAZONE SODIUM/SULBACTAM SODIUM); ZOSYN (TAZOBACTAM SODIUM/PIPERACILLIN SODIUM); AND MEROPEN (MEROPENEM HYDRATE). THE REPORTING PHYSICIAN COMMENTED THAT THE SITE OF LOW-DENSITY AREA (LDA) DIFFERENT FROM THE POST-TREATMENT SITE AND THE SITE OF CHOLEDOCHOJEJUNOSTOMY WERE CONSIDERED TO BE RELATED TO EACH OTHER. FOR THE SITE OF BILOMA AND THE SITE OF LDA, THEY WERE NEAR BUT THE RELATIONSHIP BETWEEN THEM WAS UNKNOWN. CASE COMMENT: LIVER ABSCESS AND BILOMA ARE UNLISTED ACCORDING TO THE CURRENT DC BEAD INSTRUCTION FOR USE. THE COMPANY ASSESSED THE EVENTS LIVER ABSCESS AND BILOMA AS RELATED TO DC BEAD, SINCE ITS ROLE CANNOT BE EXCLUDED. AS MENTIONED BY THE AUTHOR, PATIENT'S MEDICAL HISTORY COULD ALSO HAVE CONTRIBUTED TO THE OCCURRENCE OF THE EVENTS. 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 FOLLOW-UP INFORMATION RECEIVED ON 16-JUL-2015, DOES NOT CHANGE THE ASSESSMENT OF THE CASE. THE FOLLOW-UP INFORMATION RECEIVED ON 31-JUL-2015, DOES NOT CHANGE THE ASSESSMENT OF THE CASE. THE FIRST SALES FOR DC BEAD IN THE (B)(6) WERE IN 2004. SALES DATA FROM JAN-2010 FOR DC BEAD IS: EU 116.815 VIALS AND ROW 59.919 VIALS. FINAL ASSESSMENT RECEIVED ON 22-DEC-2015: THE COMPANY CONSIDERS THE EVENTS OF LIVER ABSCESS AND BILOMA AS RELATED TO DC BEAD, SINCE ITS ROLE CANNOT BE EXCLUDED. NO FURTHER FOLLOW UP INFORMATION IS EXPECTED. NO DEVICE FAILURE HAS BEEN IDENTIFIED AS A RESULT OF THIS ADVERSE EVENT. IT HAS BEEN ASSESSED THAT NO CORRECTIVE ACTION IS NECESSARY AT THIS TIME. THIS REPORT IS CONSIDERED FINAL. THE CASE IS CLOSED.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION RECEIVED ON JULY 16, 2015: ADDITIONAL INFORMATION WERE PROVIDED BY THE PHYSICIAN WHO INITIALLY REPORTED THE CASE. THE PATIENT WAS A (B)(6) MALE PATIENT. PATIENT'S MEDICAL HISTORY WAS REPORTED AS HEPATOCELLULAR CARCINOMA (3 OR MORE TUMORS, MAXIMUM TUMOR DIAMETER: 35MM), BILIARY DISEASE OBSTRUCTION AFTER CHOLEDOCHOJEJUNOSTOMY. ADDITIONAL INFORMATION ON TACE PROCEDURE WAS PROVIDED: ON AN UNKNOWN DATE, ONE SINGLE TACE WAS PERFORMED USING ONE VIAL OF DC BEAD (100-300 MICROM), LOADED WITH EPIRUBICIN 40 MG. THE DEGREE OF EMBOLIZATION WAS SLOW (FOR THE DISAPPEARANCE RATE OF CONTRAST MEDIUM, 5 HEARTBEATS AFTER CONTRACT MEDIUM INJECTION WERE USED AS A REFERENCE). THE EMBOLIZATION SITES WERE S7 PERIPHERAL AND S6 SUBSEGMENT. ON AN UNKNOWN DATE, CT FINDINGS SHOWED BILIOMA (BILIARY CYST), BUT IT WAS UNKNOWN IF THE PATIENT HAD IT BEFORE THE DEVELOPMENT OF LIVER ABSCESS. ON (B)(6) 2015: ADRIAMYCIN WAS ADMINISTERED TO INTRODUCE NEXAVAR (SORAFENIB TOSILATE), AFTER TACE. IN THE LIVER, IN ADDITION TO THE SITE POSSIBLY WITH A POST-TREATMENT CHANGE, MULTIPLE LOW-DENSITY AREAS (LDAS) WERE SEEN. TO THE LDA DIFFERENT FROM THE POST-TREATMENT SITE, PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) CATHETER WAS INSERTED IN TREE SITES, BUT IT RESULTED IN POOR CONTROL. AT THE TIME OF REPORTING, THE PATIENT WAS BEING TREATED AND THE EVENT WAS NOT RESOLVED. OF THE ABOVE SURVEY ITEMS, THE FACTORS THAT MAY HAVE BEEN THE POSSIBLE CAUSES OF THE DEVELOPMENT OF LIVER ABSCESS WERE THE UNDERLYING DISEASE (HCC), THE PAST HISTORY OF BILIARY DISEASE OBSTRUCTION AFTER CHOLEDOCHOJEJUNOSTOMY BUT THE REPORTING ALSO STATED THAT LIVER ABSCESS IS POSSIBLY RELATED TO DC BEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465141 DC BEAD HCG/KRD HCG BIOCOMPATIBLES UK LTD 100-300 MICROM

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other