BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOGOLD MICROSPHERES

    MDR report key: 420628 · Received October 2, 2002

    Report

    Report Number
    1226551-2002-00010
    Event Type
    Injury
    Date Received
    October 2, 2002
    Date of Event
    September 6, 2002
    Report Date
    October 2, 2002
    Manufacturer
    BIOSPHERE MEDICAL, SA/BAT A-PARC DES NATIONS
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS EMBOLIZED FOR JNA TUMOR AND EXPERIENCED BLURRY VISION AND A LEFT LATERAL FIELD CLIP REPRESENTING APPROXIMATELY 1/8 OF THE VISION IN THEIR LEFT EYE IMMEDIATELY AFTER EMBOLIZATION. THE JNA WAS LOCATED IN THE LEFT INFRA-ORBITAL/NASAL REGION OF THE FACE. THE MICRO CATHETER PLACED IN THE MID SECTION OF THE IMAX AND PRODUCT (APPROX. 50 CC'S) WAS INJECTED. THE ANGIOGRAPHIC ENDPOINT DEMONSTRATED PRUNING OF THE DISTAL IMAX BRANCHES WITH SPHENOPALATINE BRANCHES INTACT. THE PHYSICIAN DID NOT VISUALIZE ANY ANASTAMOSES OR FLOW FROM THE IMAX TO THE OPHTHALMIC ARTERY PRE/INTRA/POST EMBOLIZATION. NO VISUALIZATION OF ANY CHOROID BLUSHING OR STAINING WAS SEEN. THE PHSYICIAN WAS ABLE TO VISUALIZE THE OPHTHALMIC ARTERY VIA AN INTERNAL CAROTID ARTERY INJECTION. THE PHSYICIAN DID NOT NOTICE ANY POTENTIAL REFLUX OF EMBOLIC MATERIAL INTO THE INTERNAL/EXTERNAL COMMON CAROTID ARTERY. HE DID NOT DEFENSIVELY EMBOLIZE ANY OF THE FACIAL BRANCHES. AN OPHTHALMIC CONSULT DIAGNOSED THE PT WITH SIGNIFICANT OBSTRUCTION OR EMBOLUS LOCATED IN THE OPHTHALMIC BLOOD SUPPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOGOLD MICROSPHERES ARTIFICIAL EMBOLIC AGENT HCG BIOSPHERE MEDICAL, SA/BAT A-PARC DES NATIONS 100-300 MICRONS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other