BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 4230856 · Received November 6, 2014

    Report

    Report Number
    2029214-2014-00628
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 25, 2014
    Report Date
    October 10, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE CONSUMED IN THE EVENT. THE OTHER DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS: MODEL: 105-7000-060 / LOT: 9897509 DOM: 15 APR 2014 EXP: 16 FEB 2017; MODEL: 105-7000-060 / LOT: 9941243 DOM: 16 JUL 2014 EXP: 19 MAY 2017. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ONYX CAVM (CEREBRAL ARTERIOVENOUS MALFORMATION) PROSPECTIVE REGISTRY, (B)(6). TREATMENT OF A CAVM. ON (B)(6) 2014, THE PATIENT UNDERWENT ONYX EMBOLIZATION TREATMENT INVOLVING THREE ONYX 18. IMMEDIATELY POST PROCEDURE, THE PATIENT HAD A HEMATOMA AND REQUIRED MEDICAL INTERVENTION (SURGICAL EXCISION). THE BLEEDING WAS COMING FROM THE AVM RESIDUAL NIDUS AT THE ANTERIOR ASPECT OF LEFT TEMPORAL LOBE. THE HEMATOMA WAS NOT RELATED TO THE ONYX. IT WAS PROCEDURE RELATED. ON (B)(6) 2014, THE PATIENT WAS REPORTED TO STILL BE IN THE INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713063 ONYX AVM FLOW DIVERSION MFE COVIDIEN 105-7000-060 9911095

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R| S