BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 5776229 · Received July 7, 2016

    Report

    Report Number
    2029214-2016-00518
    Event Type
    Injury
    Date Received
    July 7, 2016
    Date of Event
    September 26, 2015
    Report Date
    June 9, 2016
    Manufacturer
    MEDTRONIC COVIDIEN
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: TAMER HASSAN, SHERIF RASHAD, WASEEM AZIZ, ET AL. "ENDOVASCULAR MODALITIES FOR THE TREATMENT OF CAVERNOUS SINUS ARTERIOVENOUS FISTULAS: A SINGLE-CENTER EXPERIENCE." DOI:10.1016/J.JST ROKECEREBROVASDIS.2015.08.016. VOLUME 24, ISSUE 12, DECEMBER 2015, PAGES 2824¿2838 THE DEVICE WAS NOT RETURNED AS IT WAS IMPLANTED IN THE PATIENT; THEREFORE, NO DEFINITIVE CONCLUSION CAN BE DRAWN REGARDING THE CLINICAL OBSERVATION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW THAT THIS PATIENT EXPERIENCED AN EMBOLIC EVENT AND TRIGEMINAL DYSESTHESIA AS A RESULT OF ONYX REFLUX THROUGH EXTERNAL CAROTID ARTERY¿ICA ANASTOMOSIS. THE ONYX EMBOLIZATION WAS VIA TRANSARTERIAL ROUTE FOR A TYPE C DURAL CAROTID¿CAVERNOUS FISTULA (DCCF) AND ONYX REFLUXED TO THE INFEROLATERAL TRUNK (ILT) AND RESULTED IN AN EMBOLIC EVENT TO ICA. THE ILT WAS NOT SEEN BEFORE EMBOLIZATION IN DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) FILMS. THE PATIENT RECOVERED WELL WITH NO SYMPTOMS REGARDING THE EMBOLIC EVENT, BUT HE HAS POSTOPERATIVE RIGHT TRIGEMINAL DYSESTHESIA, WHICH WAS TREATED MEDICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428934 ONYX AGENT, INJECTABLE, EMBOLIC MFE MEDTRONIC COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention