BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LC BEAD

    MDR report key: 3862775 · Received June 10, 2014

    Report

    Report Number
    3002124545-2014-00011
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BIOCOMPATIBLES U.K. LIMITED
    Product Code
    KRD
    PMA / PMN Number
    094018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LC BEAD IS AVAILABLE IN THE USA BUT IS NOT INDICATED FOR USE WITH DRUGS. 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. COMPANY MEDICAL ASSESSMENT: A PATIENT WITH UVEAL MELANOMA METASTATIC TO THE LIVER WAS TREATED WITH DEB-TACE WITH DC BEADS AND DOXORUBICIN. DURING THE NEXT 18 HOURS, SHE DEVELOPED NEUROLOGICAL SYMPTOMS IN THE SETTING OF SEVERE HYPERTENSION. IT IS NOT CLEAR FROM THE REPORT IF THE HYPERTENSION WAS ASSOCIATED WITH ABDOMINAL PAIN AS MIGHT BE SEEN WITH POST-EMBOLIZATION SYNDROME. HER TRANSAMINASES WERE MILDLY ELEVATED AT THIS TIME. AN MRI OF THE BRAIN WAS CONSISTENT WITH POSTERIOR REVERSIBLE LEUKOENCEPHALOPATHY SYNDROME. THE PATIENT WAS TREATED WITH ANTIHYPERTENSIVES AND HAD COMPLETE NORMALIZATION OF HER NEUROLOGIC SYMPTOMS. IT IS NOT CLEAR WHETHER THE POSTERIOR REVERSIBLE LEUKOENCEPHALOPATHY SYNDROME WAS DIRECTLY RELATED TO THE DEB-TACE PROCEDURE OR WAS DUE TO THE HYPERTENSION, WHICH ITSELF IS A KNOWN CAUSE OF POSTERIOR REVERSIBLE LEUKOENCEPHALOPATHY SYNDROME. IF THE CAUSAL EVENT WAS HYPERTENSION, IT IS NOT CLEAR WHETHER IT WAS RELATED TO THE DEB-TACE PROCEDURE. DUE TEMPORAL NATURE OF THE EVENT TO THE DEB-TACE TREATMENT, THIS EVENT WAS ASSESSED AS MEDICALLY REPORTED.

    Description of Event or Problem · 1

    THIS ADVERSE EVENT WAS IDENTIFIED FOLLOWING A LITERATURE SEARCH BY BIOCOMPATIBLES ON MAY 1, 2014. A CASE REPORT WAS PUBLISHED IN THE JOURNAL OF GASTROINTESTINAL ONCOLOGY (JGO) 2014 - VOL. 5, ISSUE 2, PAGES E43 - E45, REGARDING POSTERIOR REVERSIBLE LEUKOENCEPHALOPATHY SYNDROME SECONDARY TO HEPATIC TRANSARTERIAL CHEMOEMBOLIZATION WITH DOXORUBICIN DRUG ELUTING BEADS. (B)(6) YEAR OLD FEMALE DIAGNOSED WITH UVEAL MELANOMA (UM) WITH LIVER METASTASIS WAS PLACED ON LOCAL TACE TREATMENT. SHE RECEIVED THREE TACE TREATMENTS WITH CARMUSTINE, AND ONE TACE WITH DEBDOX. AN MRI PERFORMED POST THESE CYCLES SHOWED PERSISTENCE OF EXTENSIVE LIVER METASTASIS DESPITE THE ABOVE MENTIONED THERAPY. THE PATIENT THEREFORE RECEIVED A SECOND CYCLE OF TACE-DEBDOX ONE MONTH LATER. EIGHTEEN HOURS AFTER TACE-DEBDOX, THE PATIENT EXPERIENCED EXPRESSIVE APHASIA, BILATERAL BLURRY VISION, DYSARTHRIA AND DYSMETRIA. ABDOMINAL EXAM REVEALED MILD HEPATOMEGALY AND UPPER ABDOMINAL TENDERNESS WITHOUT GUARDING OR RIGIDITY. BP WAS TREATED WITH INTRAVENOUS METOPROLOL. BRAIN MRI SHOWED A HYPER INTENSE SIGNAL IN THE SUBCORTICAL WHITE MATTER OF THE BILATERAL OCCIPITAL LOBES, CONSISTENT WITH POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME (PRES). SINCE HER PRES AS ATTRIBUTED TO SIGNIFICANTLY ELEVATED BP AS A RESULT OF CHEMOTHERAPY, AGGRESSIVE CONTROL OF HER HYPERTENSION WAS INITIATED. REDUCTION OF THE MEAN ARTERIAL PRESSURE RESULTED IN RESOLUTION OF HER SYMPTOMS WITHIN 24 HOURS. THE PATIENT DID WELL AND WAS DISCHARGED FROM THE HOSPITAL. THE AUTHOR STATED THAT THIS WAS THE FIRST REPORT OF PRES SECONDARY TO TACE-DEBDOX IN A PATIENT WITH LIVER METASTASES FROM UM; ONE PRIOR REPORT RELATES TO PRES SECONDARY TO TACE-DEBDOX REPORTED IN A BREAST CANCER PATIENT. THE AUTHOR ALSO STATED THAT PRES WAS ASSOCIATED WITH SYSTEMIC CHEMOTHERAPY, INCLUDING DOXORUBICIN; HOWEVER, THERE IS SIGNIFICANTLY LESS DATA AND EXPERIENCE WITH LOCAL ADMINISTRATION THROUGH TACE-DEBDOX. SINCE ELEVATED BP IS A KNOWN COMPLICATION OT FACE THE PROCEDURE ITSELF COULD MAKE THESE PATIENTS MORE SUSCEPTIBLE TO THE SIDE EFFECTS OF CHEMOTHERAPEUTICS SUCH AS DOXORUBICIN, EVENT IF THEY ARE LOCALLY ADMINISTERED. AS THE PATIENT UNDERWENT FIVE TACE PROCEDURES, TWO OF WHICH INVOLVED DEBDOX, THERE MAY BE A ROLE FOR CUMULATIVE EFFECTS ON THE CEREBRAL ENDOTHELIAL CELL PERMEABILITY AND BLOOD FLOW REGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339147 LC BEAD EMBOLIC AGENT KRD BIOCOMPATIBLES U.K. LIMITED UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization CARMUSTINE| DOXORUBICIN