BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6001068 · Received October 5, 2016

    Report

    Report Number
    2029214-2016-00872
    Event Type
    Injury
    Date Received
    October 5, 2016
    Report Date
    September 6, 2016
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: CHRISTOPH J. GRIESSENAUER, LUCY HE, MOHAMED SALEM, MICHELLE H. CHUA, CHRISTOPHER S. OGILVY, AND AJITH J. THOMAS. MIDDLE MENINGEAL ARTERY: GATEWAY FOR EFFECTIVE TRANSARTERIAL ONYX EMBOLIZATION OF DURAL ARTERIOVENOUS FISTULAS. 2016 WILEY PERIODICALS, INC. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT. THE ONYX MODEL AND LOT NUMBER WERE NOT PROVIDED. THERE IS LIMITED INFORMATION ABOUT THE DEVICE AND/OR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE PURPOSE OF THE ARTICLE WAS TO EVALUATE THE ROLE OF THE MIDDLE MENINGEAL ARTERY (MMA) IN ENDOVASCULAR TREATMENT OF NONCAVERNOUS SINUS DURAL ARTERIOVENOUS FISTULAS (DAVFS). THE STUDY CONCLUDED THAT TRANSVERSE-SIGMOID DAVFS WITH ROBUST MIDDLE MENINGEAL ARTERY SUPPLY CAN BE SUCCESSFULLY TREATED WITH TRANSARTERIAL ONYX EMBOLIZATION ALONE.

    Additional Manufacturer Narrative · 1

    SAME LITERATURE ARTICLE AS REPORTED IN MDR MFR: 2029214-2016-00857, 2029214-2016-00869, 2029214-2016-00870, 2029214-2016-00871, 2029 214-2016-00873, 2029214-2016-00874.

    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 OF A RETROSPECTIVE COHORT STUDY ON PATIENTS WHO UNDERWENT TRANSARTERIAL ONYX EMBOLIZATION OF A NONCAVERNOUS SINUS DAVFS WITH CONTRIBUTION FROM THE MMA AT A MAJOR ACADEMIC INSTITUTION IN THE UNITED STATES FROM JANUARY 2009 TO JANUARY 2015 THAT THIS PATIENT EXPERIENCED A NEUROLOGICAL DEFICIT AFTER THE PROCEDURE. THIS (B)(6) MALE PATIENT PRESENTED WITH TINNITUS. THE DAVF WAS LOCATED IN THE POSTERIOR CRANIAL FOSSA (CEREBELLAR VEINS) WHICH WAS CLASSIFIED AS COGNARD AND BORDEN CLASS III. THE DAVF HAD 5 ARTERIAL FEEDERS: BILATERAL MIDDLE MENINGEAL ARTERY (MMA), BILATERAL OCCIPITAL ARTERY, R POSTERIOR MENINGEAL ARTERY. THE MMA WAS ROBUST AND 1 TREATMENT SESSION WAS CONDUCTED, EMBOLIZING 1 ARTERY. FINAL DSA SHOWED COMPLETE CURE OF THE DAVF. THE PATIENT'S NEUROLOGICAL OUTCOME WAS ATAXIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651851 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other