BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 5846878 · Received August 4, 2016

    Report

    Report Number
    2029214-2016-00650
    Event Type
    Injury
    Date Received
    August 4, 2016
    Date of Event
    January 1, 2016
    Report Date
    July 6, 2016
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
    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: QI WU, XIANG-SHENG ZHANG, HAN-DONG WANG. "ONYX EMBOLIZATION FOR TENTORIAL DURAL ARTERIOVENOUS FISTULA WITH PIAL ARTERIAL SUPPLY: CASE SERIES AND ANALYSIS OF COMPLICATIONS." WORLD NEUROSURG. (2016) 92:58-64. HTTP://DX.DOI.ORG/10.1016/J.WNEU.2016.04.033. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT WAS CONSUMED DURING THE PROCEDURE. BASED ON THE REPORTED INFORMATION, THERE DID NOT APPEAR TO HAVE BEEN ANY DEFECT OF THE DEVICE DURING USE. WE ARE UNABLE TO DEFINITIVELY DETERMINE THE CAUSE OF THE EVENT. MDR RELATED TO THIS EVENT: 2029214-2016-00650, 2029214-2016-00651.

    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 REVIEW OF LITERATURE THAT THE PATIENT EXPERIENCED CONFIRMED INTRACEREBELLAR HEMORRHAGE AFTER LEFT MIDDLE MENINGEAL ARTERY (MMA) ONYX EMBOLIZATION. IT WAS REPORTED THAT AFTER EMBOLIZATION, BILATERAL COMMON CAROTID ARTERY ANGIOGRAMS DEMONSTRATED COMPLETE OCCLUSION OF THE FISTULA AND PATENCY OF NORMAL VENOUS DRAINAGE; HOWEVER, HEMORRHAGE WAS LATER DETECTED BY A VERTEBRAL ARTERY ANGIOGRAM. A HEAD COMPUTED TOMOGRAPHY SCAN PERFORMED AFTER THE PROCEDURE CONFIRMED INTRACEREBELLAR HEMORRHAGE. CRANIOTOMY EVACUATION OF THE HEMATOMA WAS IMMEDIATELY PERFORMED FOR THIS PATIENT. POSTOPERATIVE PATHOLOGIC ANALYSIS SUGGESTED A DIAGNOSIS OF VASCULAR MALFORMATION. THIS PATIENT WAS DISCHARGED WITH HEMIPARALYSIS, AND WAS SYMPTOMATIC (GLASGOW OUTCOME SCALE SCORE OF 4) AFTER 7 MONTHS. FOLLOW-UP DSA PERFORMED AT 7 MONTHS CONFIRMED COMPLETE OBLITERATION OF THE TENTORIAL DURAL ARTERIOVENOUS FISTULA (DAVF).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498160 ONYX AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention| S