BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX

    MDR report key: 6517642 · Received April 24, 2017

    Report

    Report Number
    2029214-2017-00536
    Event Type
    Injury
    Date Received
    April 24, 2017
    Report Date
    March 28, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EMBOLIC MATERIAL WAS NOT RETURNED FOR ANALYSIS. ATTEMPTS WERE MADE TO OBTAIN CONTACT INFORMATION TO GATHER SPECIFIC INFORMATION, HOWEVER, OUR ATTEMPTS WERE UNSUCCESSFUL. BASED ON THE REPORTED INFORMATION, THERE IS NO ALLEGATION THAT A MALFUNCTION OR DEFICIENCY OF THE EMBOLIC MATERIAL OCCURRED DURING THE PROCEDURE. NEUROLOGICAL CHANGES AND HEMORRHAGES ARE KNOWN INHERENT RISK OF ENDOVASCULAR PROCEDURE AND ARE DOCUMENTED IN OUR DEVICE¿S INSTRUCTION FOR USE (IFU). THERE IS NO EVIDENCE SUGGESTING THAT THE MATERIAL WAS DEFECTIVE, BUT RATHER A PROCEDURE AND PATIENT CONDITION RELATED EVENT. LINKED EVENTS: 2029214-2017-00534 2029214-2017-00535 2029214-2017-00536.

    Description of Event or Problem · 1

    CITATION: ¿EMBOLIZATION OF CEREBRAL ARTERIOVENOUS MALFORMATIONS WITH ONYX: CLINICAL EXPERIENCE IN 44 CASES¿ LUAN LI-MING , GE MING-XU, X UE YAN, PANG QI, LI GUO-XIN SHANDONG PROVINCIAL HOSPITAL , JINAN 250021, P . R. CHINA EFFECTIVE EMBOLIZATION WAS ACHIEVED IN ALL 44 CASES. MILD HEMIPARALYSIS HAPPENED IN 2 CASES, IN WHICH THE HEMIPARALYSIS WAS MARKEDLY IMPROVED AFTER ADMINISTRATION OF VASOACTIVE MEDICINE TO ENHANCE THE MICROCIRCULATION. INTRACRANIAL HEMORRHAGE HAPPENED IN 1 CASE, IN WHICH MILD HEMIPARALYSIS REMAINED AFTER IMMEDIATE HEMATOMA REMOVAL VIA CRANIOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299061 ONYX AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention