BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX, AVM

    MDR report key: 3995183 · Received August 8, 2014

    Report

    Report Number
    2029214-2014-00473
    Event Type
    Injury
    Date Received
    August 8, 2014
    Report Date
    July 14, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS CONSUMED IN THE EVENT.(B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM AN ARTICLE: GHRANDI R, PANCZYKOWSKI D, ZWAGERMAN NT, ET AL. FACIAL NECROSIS AFTER ENDOVASCULAR ONYX-18 EMBOLIZATION FOR EPISTAXIS. SURG NEUROL INT. 22-JUL-2013;4:95. THE PATIENT PRESENTED WITH A HISTORY OF AORTIC VALVE REPLACEMENT, MITRAL VALVE REPAIR, AND DEEP VENOUS THROMBOSIS. THE PATIENT WAS ON LONG TERM ANTICOAGULATION THERAPY (WARFARIN AND ASPIRIN) AND DEVELOPED EPISTAXIS IN THE RIGHT NARIS. THE PATIENT WAS TREATED WITH BLOOD PRODUCTS, PACKING, LIGATION OF THE SPHENOPALATINE ARTERY, AND SILVER NITRATE; HOWEVER ALL WERE UNSUCCESSFUL IN CONTROLLING THE BLEEDING. SHE WAS THEN TREATED WITH ONYX 18 AND ADEQUATE OCCLUSION WAS REVEALED ON REPEAT RUNS. THREE DAYS AFTER THE PROCEDURE, THE PATIENT NOTICED A HYPERPIGMENTATION ON THE LEFT SIDE OF HER CHEEK THAT WAS ERYTHEMA AND TENDER TO THE TOUCH. A BIOPSY REVEALED FULL-THICKNESS EPIDERMAL NECROSIS, UPPER AND MID DERMIS, FOLLICLES, SEBACEOUS GLAND AND ECCRINE GLANDS. SHE WAS TREATED WITH TOPICAL OINTMENTS AND DRESSING CHANGES (NO OTHER TREATMENT WAS PROVIDED). THE SKIN NECROSIS RESOLVED MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469302 ONYX, AVM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-7100-060 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention| S