BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX AVM

    MDR report key: 4926394 · Received July 20, 2015

    Report

    Report Number
    2029214-2015-00799
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    June 15, 2015
    Report Date
    July 8, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ONYX WAS NOT RETURNED FOR EVALUATION AS IT WAS CONSUMED IN THE EVENT. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE ONYX WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS NOT REPORTED. NOTE: PER THE ONYX IFU (INSTRUCTIONS FOR USE) WARNINGS: DO NOT ALLOW MORE THAN 1 CM OF ONYX LES TO REFLUX BACK OVER CATHETER TIP. EXCESSIVE ONYX REFLUX MAY RESULT IN DIFFICULT CATHETER REMOVAL AND CATHETER ENTRAPMENT. (B)(4). INFORMATION RECEIVED FROM THE SAME REPORT AS MFR: 2029214-2015-00800.

    Additional Manufacturer Narrative · 1

    CORRECTION TO EVENT DESCRIPTION: THERE WAS .1 CM OF REFLUX PASSED THE DETACHMENT ZONE. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC (COVIDIEN) RECEIVED REPORT THAT AN APOLLO MICROCATHETER BECAME ENTRAPPED AND STUCK; A SEGMENT PROXIMAL TO DETACHMENT POINT APPEARED ACCORDIONED. THE PHYSICIAN PAUSED DURING ONYX INJECTION WITH A WAITING TIME OF 2-3 MINUTES. THERE WAS ONYX REFLUX ABOUT 1.6 CM MEANING .01 CM OF REFLUX HAD PASSED THE DETACHMENT POINT THAT IS LOCATED AT 1.5 CM FORM THE DISTAL TIP OF THE APOLLO. THE CATHETER WAS CUT AT THE GROIN AND PUSHED INTO THE COMMON FEMORAL ARTERY AND THE PATIENT WAS PLACED ON ANTIPLATELET THERAPY. THE ENTIRE CATHETER EXCEPT FOR THE HUB REMAINS IN THE PATIENT. THE PATIENT IS RECOVERING IN REHAB FROM THE INITIAL HEMORRHAGE THAT WAS NOT RELATED TO THE PROCEDURE. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469066 ONYX AVM AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-7000-060

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR