BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSPHERE MICROSPHERES

    MDR report key: 4336126 · Received November 26, 2014

    Report

    Report Number
    9615728-2014-00003
    Event Type
    Injury
    Date Received
    November 26, 2014
    Date of Event
    June 10, 2014
    Report Date
    November 4, 2014
    Manufacturer
    BIOSPHERE MEDICAL, S.A.
    Product Code
    NAJ
    PMA / PMN Number
    K021397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING IS EXPECTED TO BE RETURNED FOR EVALUATION. SINCE THE LOT NUMBER WAS NOT PROVIDED, THE DEVICE HISTORY RECORD AND COMPLAINT DATABASE COULD NOT BE REVIEWED FOR SIMILAR ISSUES. THE INSTRUCTIONS FOR USE PROVIDE A WARNING TO PAY CAREFUL ATTENTION FOR SIGNS OF MIS-TARGETED EMBOLIZATION. DURING INJECTION, IT IS REQUIRED TO CAREFULLY MONITOR PATIENT VITAL SIGNS TO INCLUDE SAO2 (E.G. HYPOXIA, EN CHANGES). AND CONSIDER TERMINATING THE PROCEDURE, INVESTIGATING FOR POSSIBLE SHUNTING, OR INCREASING MICROSPHERE SIZE IF ANY SIGNS OF MIS-TARGETING OCCUR OR PATIENT SYMPTOMS DEVELOP. MERIT IS UNABLE TO DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A PATIENT WITH HEPATOCELLULAR CARCINOMA (STAGE III) DEVELOPED AN ACUTE PANCREATITIS IMMEDIATELY AFTER TRANS ARTERIAL EMBOLISATION (TAE) PERFORMED NEAR TO THE GASTRODUODENAL ARTERY WITH THE DEVICE (EMBOSPHERE MICROSPHERES). ON THE SAME DAY, THE PATIENT WAS PLACED ON NIL PER OS STATUS IN CONSIDERATION OF THE RISK OF ISCHEMIC PANCREATITIS DEVELOPING AS A COMPLICATION, SINCE A SMALL AMOUNT OF EMBOSPHERE SEEMED TO HAVE FLOWN BACK. EPIGASTRIC PAIN DEVELOPED SOON AFTER TREATMENT. THE PATIENT ALSO HAD STRONG QUEASINESS AND VOMITING. THE SYMPTOMS EXACERBATED AND BTH PANCREATIC AMYLASE AND LIPASE LEVELS INCREASED. THEN THE SYMPTOMS IMPROVED AFTER FUTHAN (NAFAMOSTAT MESILATE) ADMINISTRATION AND FASTING. ON (B)(6), PATIENT STARTED ORAL INTAKE. ON (B)(6) PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768505 EMBOSPHERE MICROSPHERES AGENTS, EMBOLIC, TREAT. UTER. FIBRO NAJ BIOSPHERE MEDICAL, S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O