BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6443332 · Received March 29, 2017

    Report

    Report Number
    2029214-2017-00271
    Event Type
    Injury
    Date Received
    March 29, 2017
    Report Date
    March 3, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    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. 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 THROUGH LITERATURE REVIEW THAT DURING EMBOLIZATION OF BILATERAL DURAL AVFS OF THE CAVERNOUS SINUS (CS) PROCEDURE, ONYX EMBOLIZED AN UNINTENDED AREA. THE PATIENT EXPERIENCED WORSENING OF OCULAR SYMPTOMS. IN THIS PATIENT, THE PHYSICIAN WANTED TO OBLITERATE THE BILATERAL DURAL AVF WITH ONYX VIA THE RIGHT INFERIOR PETROSAL SINUS (IPS) AND AN INTERCAVERNOUS APPROACH. BUT THE OBLITERATION OF THE POSTERIOR PART OF THE LEFT (CS) COULD NOT BE ACHIEVED AND ONYX BEGAN TO REFLUX INTO THE RIGHT SUPERIOR OPHTHALMIC VEIN (SOV), WHICH HAD BEEN INITIALLY OBLITERATED WITH DETACHABLE COILS. ANGIOGRAPHY SHOWED RESIDUAL FILLING OF THE FISTULA WITH DRAINAGE TO THE LEFT SOV AFTER THE PROCEDURE. THE PATIENT DEVELOPED LEFT WORSENING OF PROPTOSIS, AND CHEMOSIS AND REFLUX OF ONYX INTO THE RIGHT (SOV) WAS WITHOUT CLINICAL SEQUELAE. IT WAS NOTED BY THE AUTHOR THAT THE SYMPTOMS WERE ATTRIBUTED TO THE OCCLUSION OF THE LEFT INFERIOR PETROSAL SINUS, WHICH DRAINED THE FISTULA. IN A SECOND ATTEMPT, A DIRECT ACCESS OF THE (SOV) VIA THE FACIAL VEIN WAS ATTEMPTED TO OCCLUDE THE POSTERIOR PART OF THE FISTULA, BUT FAILED. THE PATIENT WAS TREATED BY CAROTID COMPRESSION. THE PATIENT WAS TREATED WITH ONYX 18 OR ONYX 34 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 AT OUR HOSPITAL. ONYX MIGRATION WAS ENCOUNTERED IN FIVE PATIENTS WITH DURAL AVFS TREATED ENDOVASCULARLY. TWO PATIENTS WERE TREATED TRANS ARTERIALLY AND THREE WERE TREATED TRANSVENOUSLY 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
    224973 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) UNK-NV-ONYX NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention