BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX AVM

    MDR report key: 7861914 · Received September 10, 2018

    Report

    Report Number
    2029214-2018-00789
    Event Type
    Injury
    Date Received
    September 10, 2018
    Date of Event
    September 3, 2018
    Report Date
    September 10, 2018
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ONYX WAS NOT RETURNED FOR ANALYSIS AS IT WAS CONSUMED IN THE PROCEDURE. BASED ON THE REPORTED INFORMATION, THERE WAS NO ALLEGATION THAT A MALFUNCTION OR DEFICIENCY OF THE ONYX OCCURRED DURING THE EMBOLIZATION PROCEDURE. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE ONYX WAS DEFECTIVE, BUT RATHER A PROCEDURE AND PATIENT CONDITION RELATED EVENT. HEMODYNAMIC CHANGES IN BLOOD FLOW PATTERN MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS, HOWEVER, THE EXACT CAUSE OF THE THROMBUS AND THE POST PROCEDURE EVENT REMAIN UNKNOWN. THROMBUS AND NEUROLOGICAL DETERIORATION ARE KNOWN INHERENT RISKS OF THE MECHANICAL THROMBECTOMY PROCEDURE AND ARE DOCUMENTED IN OUR DEVICES¿ INSTRUCTIONS FOR USE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THAT POST THE ONYX EMBOLIZATION PROCEDURE, THE PATIENT EXPERIENCED A NEUROLOGICAL DETERIORATION AND DYSPHAGIA. DURING THE EMBOLIZATION, THERE WAS THROMBUS AROUND FUBUKI 7F GUIDEWIRE SO THERE SEEMED TO BE EMBOLISM NEAR PICA. PER THE TREATING PHYSICIAN, THE EMBOLISM WAS NOT RELATED TO THE ONYX. THE EMBOLISM LOCATION WAS IN THE CRANIOCERVICAL JUNCTION (CCJ). PRIMARY DISEASE: CEREBRAL INFARCTION AND CEREBRAL HEMORRHAGE. EMBOLIZATION OF THE CRANIOCERVICAL JUNCTION (CCJ) WAS PERFORMED WITH ONYX AND THE CEREBRAL ARTERIOVENOUS FISTULA EMBOLIZATION PROCEDURE WAS FINISHED. REOPERATION WAS NOT REQUIRED AND THE PATIENT IS ONLY BEING MONITORED. THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY AND SMALL IN DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702404 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-7100-060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other