BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DC BEAD

    MDR report key: 4435679 · Received December 23, 2014

    Report

    Report Number
    3002124545-2014-00036
    Event Type
    Injury
    Date Received
    December 23, 2014
    Date of Event
    November 28, 2014
    Report Date
    December 22, 2014
    Manufacturer
    BIOCOMPATIBLES U.K. LIMITED
    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 PT. THE EQUIVALENT PRODUCT, LC BED, IS AVAILABLE IN THE USA AND IS INDICATED FOR THE TREATMENT OF HYPERVASCULAR TUMOURS AND AVMS. 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. MANUFACTURER INITIAL ASSESSMENT: THIS EVENT CONCERNS A PT WHO RECEIVED DEB-TACE IN (B)(6) 2014 AND WAS NOTED TO HAVE BILOMA ON IMAGING STUDIES IN (B)(6) 2014. FURTHER INFORMATION WAS REQUESTED TO IDENTIFY WHETHER BILOMA WAS AN INCIDENTAL FINDING OR IF DRAINAGE WAS REQUIRED OR SIGNS OF INFECTION OR OBSTRUCTION OF THE BILIARY SYSTEM WAS NOTED. ADDITIONAL INFORMATION RECEIVED ON DEC 18 2014 INDICATES THAT PT HAD A LIVER ABSCESS REQUIRING DRAINAGE AND ANTIBIOTICS. THIS INFORMATION DOES INDICATE SERIOUS HARM TO PT. THIS EVENT IS CURRENTLY UNDER INVESTIGATION BY THE MANUFACTURER AND THE CONCLUSION OF THIS INVESTIGATION WILL BE COMMUNICATED AS A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER ASSESSMENT: PATIENT DEVELOPED "BILOMA" AFTER DEB-TACE PROCEDURE. AFTER SEVERAL MONTHS, IT IS NOW REPORTED THAT THIS EVENT IS RESOLVING. THIS REMAINS A MEDICALLY REPORTABLE EVENT. THE POTENTIAL CONTRIBUTORY FACTORS WERE INVESTIGATED AND ASSESSED AS PART OF THIS COMPLAINT. NO SINGULAR ROOT CAUSE WAS IDENTIFIED ON THIS OCCASION. THIS IS THE FIRST REPORT OF BILOMA RECEIVED BY THE COMPANY AND LIVER ABSCESS IS AN ANTICIPATED COMPLICATION OF THE PROCEDURE. THERE WAS NO INCREASED TREND IN REPORTING OF THESE TYPES OF EVENTS. THEREFORE THERE IS NO CHANGE TO THE ESTABLISHED CLINICAL RISK: BENEFIT PROFILE OF THE DEVICE. NO ADDITIONAL RISK TO PATIENTS OR USERS OUTSIDE THOSE EXPECTED FOR THE DEVICE HAS BEEN IDENTIFIED RELATING TO THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER INITIAL ASSESSMENT: PATIENT DEVELOPED "BILOMA" AFTER DEB-TACE PROCEDURE. AFTER SEVERAL MONTHS, IT IS NOW REPORTED THAT THIS EVENT IS RESOLVING. IS RESOLVING. THIS REMAINS A MEDICALLY REPORTABLE EVENT. THIS EVENT IS CURRENTLY UNDER INVESTIGATION BY THE MANUFACTURER AND THE CONCLUSION OF THIS INVESTIGATION WILL BE COMMUNICATED AS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    PREVIOUSLY REPORTED INFORMATION CONCERNS A (B)(6) YEAR OLD MALE PATIENT WITH BILOMA AND LIVER ABSCESS FOLLOWING THE DEB-TACE PROCEDURE. ON AN UNKNOWN DATE IN (B)(6) 2014, THE PATIENT RECEIVED DC BEAD (100-300 PM) 1 VIAL LOADED WITH 50 MG OF EPIRUBICIN IN THE PERIPHERAL A3 BRANCH, CENTRAL PART OF A2/A3, CENTRAL PART OF A4 AND MAIN STEM OF RHA (RIGHT HEPATIC ARTERY) . FOLLOWING THIS, ON (B)(6) 2014, THE PATIENT WAS HOSPITALIZED DUE TO PYREXIA AND OLIGURIA. CT SCAN REVEALED BILOMA AND LIVER ABSCESS. THE PATIENT'S TREATMENT MEDICATIONS INCLUDED UNSPECIFIED INTRAVENOUS ANTIBIOTICS AND PUNCTURE DRAINAGE OF LIVER CYST ABSCESS. AS OF (B)(6) 2014, BILOMA HAS NOT RESOLVED. REPORTING PHYSICIAN STATED THAT THE PATIENT HAS BEEN TREATED FOR A LONG TIME WITH THIN AND SPIDERY BLOOD -VESSELS IN THE LIVER. PHYSICIAN HAS ALSO STATED THAT THE EVENT OF BILOMA WAS POSSIBLY RELATED TO MANUFACTURER'S DEVICE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA THE DISTRIBUTOR ON (B)(6) 2015. AS OF (B)(6) 2015, THE PATIENT WAS RECOVERING FROM BILOMA AND WAS DISCHARGED. THE PHYSICIAN STATED THAT BILOMA AND LIVER ABSCESS OFTEN DEVELOP (OR MAY DEVELOP) 1 TO 2 MONTHS AFTER TACE RATHER THAN THE PERIOPERATIVE PERIOD AND THAT IN THIS CASE, TACE WAS PERFORMED AT THE SITE WHERE INTRAHEPATIC BLOOD VESSELS WERE DETERIORATED, AND NO OTHER FACTOR THAN THAT COULD BE CONSIDERED IN THE FORMATION OF BILOMA. THE REPORTER ASSESSED THE CAUSALITY BETWEEN BILOMA AND DC BEAD AS RELATED. THE PHYSICIAN CONSIDERED PYREXIA AND OLIGURIA ARE SECONDARY EVENTS ASSOCIATED WITH LIVER ABSCESS AND LIVER ABSCESS AS A SECONDARY EVENT ASSOCIATED WITH BILOMA.

    Description of Event or Problem · 1

    THIS EVENT CONCERNS A MALE PT AND THE INITIAL EVENT REPORT WAS RECEIVED FROM A USER FACILITY VIA A PARTNER ORGANIZATION ON (B)(6) 2014, WITH ADDITIONAL INFORMATION RECEIVED ON DEC 18, 2014. EVENT DETAILS AS RECEIVED BY MANUFACTURER: (B)(6) 2014, TACE (TRANS-ARTERIAL CHEMOEMBOLIZATION) WAS PERFORMED ON PT. THE PT RECEIVED DRUG-ELUTING DC BEAD (100-300 UM) 1 VIAL LOADED WITH 50 MG OF EPIRUBICIN (DILUTED TO 40ML IN TOTAL). LOADED DC BEAD PRODUCT WAS INJECTED AS FOLLOWS: IN THE PERIPHERAL A3 BRANCH, EPIRUBICIN AND DC BEAD 3 ML/40ML WAS INJECTED; IN THE CENTRAL PART OF A2/A3, EPIRUBICIN AND DC BEAD 2 ML/40ML WAS INJECTED; IN THE CENTRAL PART OF A4, EPIRUBICIN AND DC BEAD 2 ML/40ML WAS INJECTED; IN THE MAIN STEM OF RHA (RIGHT HEPATIC ARTERY), EPIRUBICIN AND DC BEAD 1 ML/40ML WAS INJECTED. FOLLOWING THIS, ON (B)(6) 2014, THE PT WAS HOSPITALIZED AFTER DEVELOPING PYREXIA AND OLIGURIA - CT SCAN REVEALED BILOMA AND LIVER ABSCESS. AS A RESULT OF CT SCAN FINDINGS, INTRAVENOUS INFUSION OF VARIOUS ANTIBIOTICS AND ARTERIAL INFUSION OF ANTIBIOTICS WERE ADMINISTERED TO THE PT. PUNCTURE DRAINAGE OF LIVER CYST ABSCESS HAD ALSO BEEN ADMINISTERED. AS OF (B)(6) 2014, BILOMA HAS NOT RESOLVED. THE PT IS STILL IN TREATMENT. REPORTING PHYSICIAN HAS STATED THAT THE PT HAS BEEN TREATED FOR A LONG TIME WITH THIN AND SPIDERY BLOOD VESSELS IN THE LIVER. PHYSICIAN HAS ALSO STATED THAT THE EVENT OF BILOMA WAS POSSIBLY RELATED TO MANUFACTURER'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847953 DC BEAD EMBOLIC AGENT, HCG/KRD HCG BIOCOMPATIBLES U.K. LIMITED 100-300 UM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| O