BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DC BEAD

    MDR report key: 3600376 · Received January 30, 2014

    Report

    Report Number
    3002124545-2013-00012
    Event Type
    Injury
    Date Received
    January 30, 2014
    Report Date
    November 28, 2013
    Manufacturer
    BIOCOMPATIBLES U.K. LIMITED
    Product Code
    HCG
    PMA / PMN Number
    K094018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY COMMENT: DC BEAD LOADED WITH IRINOTECAN WAS USED IN THE TREATMENT OF THIS PATIENT. THE EQUIVALENT PRODUCT LC BEAD IS AVAILABLE IN THE USA, HOWEVER, IT IS NOT INDICATED FOR USE WITH DRUGS. COMPANY MEDICAL REVIEW DETERMINED THAT THIS PATIENT DEVELOPED STROKE PROBABLY IN THE CONTEXT OF NON-TARGET EMBOLIZATION TO HER BRAIN THROUGH NON-VISIBLE HEPATIC AV SHUNTS. THE DC BEAD IFU DOCUMENTS UNDESIRABLE REFLUX OR PASSAGE OF DC BEAD MICROSPHERES INTO NORMAL ARTERIES ADJACENT TO THE TARGETED LESION OR THROUGH THE LESION INTO OTHER ARTERIES OR ARTERIAL BEDS AND ISCHAEMIC STROKE OR ISCHAEMIC INFARCTION AS POTENTIAL COMPLICATIONS OF PRODUCT USE. THIS IS THEREFORE AN ANTICIPATED COMPLICATION. INVESTIGATION INTO THIS COMPLAINT IS ONGOING.

    Description of Event or Problem · 1

    REPORT FROM (B)(6) VIA MEDICAL DIRECTOR OF A FEMALE, (B)(6) YEAR OLD PATIENT DIAGNOSED WITH LIVER METASTASES FROM COLORECTAL CANCER. HER LIVER METASTASES WERE TREATED WITH CHEMOEMBOLIZATION WITH IRINOTECAN LOADED DC BEAD (100-300 MICRONS LOADED WITH 100MG IRINOTECAN). NO SHUNTING WAS IDENTIFIED DURING ANGIOGRAM. THE PATIENT DID NOT HAVE ANY PREVIOUS CARDIAC MEDICAL HISTORY. NO MEDICAL HISTORY OF STROKE. DURING THE PROCEDURE THE PATIENT EXPERIENCED DIFFICULTY TO TALK AND SHE COMPLAINED THAT SHE COULD NOT FEEL HER LEG. A BRAIN MRI SHOWED AN AREA OF DEVASCULARISATION COMPATIBLE WITH HER NEUROLOGICAL SYMPTOMS. PATIENT WAS HOSPITALIZED AFTER TREATMENT AND HER SYMPTOMS WORSENED OVER A 48 HOUR PERIOD. FOLLOW-UP WITH THE HOSPITAL IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64899 DC BEAD EMBOLIC AGENT HCG BIOCOMPATIBLES U.K. LIMITED 100-300 V10462

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening DC BEAD WAS LOADED WITH IRINOTECAN PRIOR TO USE