BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOSPHERE EMBOSPHERES

    MDR report key: 6449404 · Received March 31, 2017

    Report

    Report Number
    9615728-2017-00012
    Event Type
    Death
    Date Received
    March 31, 2017
    Date of Event
    August 23, 2016
    Report Date
    March 13, 2017
    Manufacturer
    BIOSPHERE MEDICAL SA
    Product Code
    NAJ
    PMA / PMN Number
    K021397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WILL NOT BE RETURNED FOR EVALUATION SINCE IT IS A PERMANENT IMPLANT WHICH CANNOT BE RECALLED. A SEARCH OF THE COMPLAINT DATABASE AND DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT AN ELDERLY MAN WAS TREATED VIA TRANS ARTERIAL CHEMOEMBOLIZATION (TACE) USING AN INTRAVENOUS INJECTION OF CISPLATIN FOLLOWED BY EMBOLIZATION WITH EMBOSPHERE ON (B)(6) 2016. IMMEDIATELY AFTER THE INFUSION OF EMBOSPHERE, A VASCULAR LAKE APPEARED INSIDE THE TUMOR. ON (B)(6), 2016 PYREXIA DID NOT IMPROVE, LIVER DISORDER PERSISTED, AND DYSPNEA DEVELOPED. SEPTIC SHOCK DUE TO INFECTION AFTER TACE AND DIC WERE SUSPECTED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL, AND THE GENERAL CONDITION OF THE PATIENT WAS MANAGED IN THE INTENSIVE CARE UNIT FROM (B)(6) 2016. LIVER ABSCESS DRAINAGE AND ANTIBIOTIC THERAPY WERE PERFORMED. ON (B)(6) 2016 PYREXIA DEVELOPED, AND INCREASED C-REACTIVE PROTEIN LEVELS WERE NOTED. A SWITCH TO MEROPENEM HYDRATE AT 3 G/DAY WAS THUS MADE. ON (B)(6) 2016 PNEUMONIA DEVELOPED. SPUTUM CULTURE YIELDED POSITIVE RESULTS FOR (B)(6), AND ADMINISTRATION OF VANCOMYCIN HYDROCHLORIDE WAS THUS INITIATED. ON (B)(6) 2016 ENLARGED LIVER ABSCESS IN SEGMENT 8 WAS NOTED AND A DRAINAGE TUBE WAS PLACED. ON (B)(6) 2016 INCREASED PLEURAL EFFUSION WAS NOTED, AND LEFT PLEURAL FLUID WAS DRAINED. ON (B)(6) 2016 WORSENING RESPIRATORY STATUS WAS NOTED. ON (B)(6) 2016 LIVER ABSCESS IN SEGMENT 7 WAS CONFIRMED TO HAVE SHRUNK AND THE DRAINAGE TUBE WAS REMOVED. AN ADDITIONAL DRAINAGE TUBE WAS PLACED FOR LIVER ABSCESS IN SEGMENT 8. ON (B)(6) 2016 THE PATIENT WAS HOSPITALIZED AGAIN. THE PATIENT DIED ON AN UNKNOWN DAY IN (B)(6) 2017. THE DISTRIBUTOR STATED THAT INVESTIGATIONAL RESULTS REVEALED THAT WORSENING OF THE PRIMARY DISEASE AND A PERSISTENT TUMOR-ASSOCIATED INFECTION RESULTED IN THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233002 BIOSPHERE EMBOSPHERES EMBOSPHERES NAJ BIOSPHERE MEDICAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death 3F SHEATH| CISPLATIN, IA, 50MG| GELPART| MEDIKIT RH CATHETER| MEROPENEM HYDRATE 3G/DAY| NEO CERISIER SS| PIPERACILLIN| TAZOBACTAM