BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6443336 · Received March 29, 2017

    Report

    Report Number
    2029214-2017-00272
    Event Type
    Injury
    Date Received
    March 29, 2017
    Report Date
    March 3, 2017
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ONYX MIGRATION IN THE ENDOVASCULAR MANAGEMENT OF INTRACRANIAL DURAL ARTERIOVENOUS FISTULAS H.WANG, X. LV, C. JIANG ET. AL THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS CONSUMED IN THE EVENT. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. THIS A PROCEDURE RELATED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE AUTHOR OF THIS ARTICLE REGARDING THIS CASE. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MDRS RELATED TO THIS EVENT: 2029214-2017-00269 2029214-2017-00270 2029214-2017-00271 2029214-2017-00272 2029214-2017-00273.

    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 DURING LITERATURE REVIEW THAT DURING EMBOLIZATION PROCEDURE, ONYX EMBOLIZED IN TO THE UNINTENDED AREA. THE PATIENT HAD DURAL ANTERIOR VENOUS FISTULA (AVF), INVOLVING THE BILATERAL CAVERNOUS SEGMENT (CS). THIS PATIENT WAS TREATED IN TWO SESSIONS. HOWEVER, AFTER EMBOLIZATION OF THE RIGHT CAVERNOUS SINUS CS VIA THE RIGHT INFERIOR PETROSAL SINUS (IPS), A SINGLE ONYX DROPLET ATTACHING TO THE MICROCATHETER DROPPED INTO THE RIGHT INTERNAL JUGULAR VEIN (IJV) AS RETRIEVED THE CATHETER. THIS PATIENT DID NOT PRESENT WITH NEW SYMPTOMS AFTER THE PROCEDURE AND NO ABNORMALITY WAS FOUND BY CHEST X-RAY FILM AND SHE WAS FOLLOWED. THIS PATIENT WAS TREATED WITH A COMBINATION OF ONYX 18 OR ONYX 34 AND COILS. IN THIS STUDY BETWEEN FEBRUARY 2007 AND AUGUST 2008, 48 PATIENTS WERE TREATED FOR DURAL ARTERIOVENOUS FISTULA BY ARTERIAL AND 17 PATIENTS BY VENOUS APPROACHES. ONYX MIGRATION WAS ENCOUNTERED IN FIVE PATIENTS WITH DURAL AVFS TREATED ENDOVASCULARLY. TWO PATIENTS WERE TREATED TRANS ARTERIALLY AND THREE WERE TREATED TRANS VENOUSLY WITH ONYX. THEY COMPRISED TWO WOMEN AND THREE MEN, RANGING IN AGE FROM 28 TO 56 (MEAN 43.6 YEARS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224976 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA UNK-NV-ONYX NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR