BEUDAMED
    FDA Adverse Event Death Summary report: N

    DC BEAD

    MDR report key: 4235823 · Received October 30, 2014

    Report

    Report Number
    3002124545-2014-00028
    Event Type
    Death
    Date Received
    October 30, 2014
    Report Date
    October 28, 2014
    Manufacturer
    BIOCOMPATIBLES U.K. LIMITED
    Product Code
    HCG
    PMA / PMN Number
    K094018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DC BEAD WITH DOXORUBICIN 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. LC BEAD IS NOT INDICATED FOR USE WITH DOXORUBICIN. THE DEVICE HAS NOT BEEN SENT TO THE MANUFACTURER FOR EVALUATION. BATCH REVIEW WILL NOT BE POSSIBLE FOR THIS CASE IF THE REPORTER DOES NOT SPECIFY LOT NUMBER. NO PRODUCT MALFUNCTION/DEFICIENCY HAS BEEN IDENTIFIED GIVEN CASE INFORMATION. MEDICAL ASSESSMENT: THIS PATIENT OF INTRA-ABDOMINAL HAEMORRHAGE DUE TO TUMOR RUPTURE 14 HOURS AFTER A DEB-DOX PROCEDURE WITH DC BEADS. LESIONS RUPTURE IS A KNOWN COMPLICATION OF THE PROCEDURE, AND IS IN THE PRODUCT IFU, BUT THE PATIENT SUFFERED SERIOUS HARM AND USER ERROR OR DEVICE MALFUNCTION CANNOT BE COMPLETELY EXCLUDED. ACCORDINGLY, THIS IS A MEDICALLY REPORTABLE CASE. THIS EVENT IS CURRENTLY UNDER INVESTIGATION BY THE MANUFACTURER AND THE CONCLUSION OF THIS INVESTIGATION WIL BE COMMUNICATED AS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, MANUFACTURER'S EMPLOYEE IDENTIFIED A PUBLICATION FROM JOURNAL CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, PUBLISHED ON 03/24/2011. THE PUBLICATION DESCRIBED THE FOLLOWING EVENT; A (B)(6)-YEAR-OLD MALE PATIENT WITH ALCOHOLIC LIVER CIRRHOSIS SUFFERING FROM MULTIFOCAL, UNILOBAR HEPATOCELLULAR CARCINOMA WAS REFERRED TO THE AUTHOR'S HOSPITAL FOR PALLIATIVE TREATMENT WITH TRANSARTERIAL CHEMOEMBOLIZATION/EMBOLISATION (TACE). AFTER THE FIRST DIAGNOSIS OF TWO LIVER/HEPATIC HEPATOCELLULAR CARCINOMA (HCC) LESIONS 18 MONTHS PREVIOUS, THE PATIENT HAD BEEN SUCCESSFULLY TREATED WITH RADIOFREQUENCY ABLATION (RFA) IN A DIFFERENT HOSPITAL. ON A RECENT COMPUTED TOMOGRAPHY (CT) SCAN, PROGRESSIVE HCC MASSES OF SEGMENTS ILL AND IVB, MEASURING S 16X9X7CM, WERE DIAGNOSED. THE PATIENT'S MEDICAL HISTORY SHOWED PERIPHERAL ARTERY DISEASE, HYPERTENSION, DIABETES, CHRONIC OBSTRUCTIVE LUNG DISEASE, AND PREVIOUS PROSTATE CANCER SURGERY. LABORATORY RESULTS, INCLUDING WHITE BLOOD CELL COUNT AND NEUTROPHILS IN ADDITION TO CHOLINESTERASE, ASPARTATE AMINOTRANSFERASE, GAMMA-GLUTAMYL TRANSFERASE, LACTATE DEHYDROGENASE, HAEMOGLOBIN AND ALPHA FETOPROTEIN, WERE NORMAL. ACCESS FOR TACE WAS PERFORMED. A MICROCATHETER WAS INSERTED TO THE LEVEL OF SEGMENTAL ARTERIES III AND IV FOLLOWED BY SUCCESSIVE INJECTION OF TWO VIALS OF 300-500 UM (4 ML) DC BEAD LOADED WITH 50MG DOXURUBICIN/VIAL MIXED WITH NONIONIC CONTRAST MEDIUM. THE PROCEDURE WAS TERMINATED AT THE POINT OF STOP-FLOW WITHIN THE MAIN FEEDING VESSELS. ACCESSION SITE WAS COMPRESSED MANUALLY FOR 15 MINUTES, AFTER WHICH A PRESSURE DRESSING WAS APPLIED FOR 24 HOURS. APPROXIMATELY 14 HOURS AFTER TREATMENT, THE PATIENT WAS FOUND INANIMATE ON THE WARD. AFTER INITIALLY SUCCESSFUL REPEATED CARDIOPULMONARY RESUSCITATION, THE HEMODYNAMICALLY INSTABLE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THERE, AN EMERGENCY ULTRASOUND OF THE ABDOMEN SHOWED MODERATE FLUID ACCUMULATION IN THE UPPER ABDOMEN, BUT NO BLEEDING SOURCE WAS FOUND IN THE GROIN OR IN THE SMALL PELVIS. FURTHER CT IMAGING WAS NOT POSSIBLE BECAUSE THE PATIENT WAS TOO INSTABLE. A DECREASE IN HAEMOGLOBIN FROM 11.3 TO 4.2 MG/DL AND AN INCREASE OF LACTATE OUT OF RANGE LEAD TO DEATH FROM CIRCULATORY SHOCK WITHIN A FEW HOURS. AUTOPSY SHOWED A MASSIVE INTRAABDOMINAL HAEMORRHAGE GREATER THAN 2 I AS WELL AS NUMEROUS CLOTS COVERING THE GREATER OMENTUM AND INTESTINAL LOOPS. ACCORDINGLY, THE INTERNAL ORGANS WERE PALE. THE BLEEDING SOURCE WAS LOCATED ON THE DIAPHRAGMATIC SIDE OF THE LEFT LIBER LOBE, WHERE AN EXTENSIVE TUMOR RUPTURE WITH CONCOMITANT PERFORATION OF THE LIVER CAPSULE HAD OCCURRED FROM A 16.0 X 9.0 X 7.0 CM FOCUS OF A MULTIFOCAL, WIDELY NECROTIC, MODERATE DIFFERENTIATED HCC. IN THE LIVER ARTERIES AND THE GALLBLADDER, AS WELL AS SPARSELY IN THE HAEMORRHAGE SCATTERED DETECTION OF DC BEAD WAS POSSIBLE. ACCORDING TO THE PATHOLOGIST, THE PATIENT DIED FROM EXCESSIVE INTRAABDOMINAL BLEEDING DUE A RUPTURED FOCUS OF THE MULTIFOCAL HCC AFTER TACE WITH DEBDOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695138 DC BEAD EMBOLIC AGENT, HCD/KRD HCG BIOCOMPATIBLES U.K. LIMITED DC BEAD (300-500UM) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death PAIN AND DISCOMFORT OWING TO LIVER CAPSULE TENSION| DURING EMBOLIZATION. TO MINIMIZE LOCAL TISSUE| AS WELL AS AN OPIOD (200 MG TRAMADOL,| BEFORE EMBOLIZATION A 5-HT3 INHIBITOR (8 MG| PROVIDED.| EMBOLIZATION, SUFFICIENT IV HYDRATION WAS| DEXAMETHASONE) IN ADVANCE. BEFORE AND AFTER| EDEMA, INJECTED A GLUCOCORTICOID (20 MG| FOR PAIN RELIEF DURING AND AFTER TREATMENT)| WERE ADMINISTERED INTRAVENOUSLY. IN ADDITION,| WAY OF THE MICROCATHETER TO DECREASE LOCAL| 50 MG PETHIDINE WAS INJECTED INTRA-ARTERIALLY BY| ONDANSETRON, A POTENT CENTRAL ANTIEMETRIC)| 300-500UM DC BEAD LOADED WITH 50MG DOXORUBICAN| MIXED WITH NONIONIC CONTRAST MEDIUM.