BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX 18, AVM

    MDR report key: 1013166 · Received March 13, 2008

    Report

    Report Number
    2029214-2008-00043
    Event Type
    Death
    Date Received
    March 13, 2008
    Date of Event
    November 8, 2007
    Report Date
    November 8, 2007
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION, AS IT WAS DISCARDED AT THE HOSP. THE ONYX AVM INSTRUCTIONS FOR USE (IFU) WARNS "DO NOT ALLOW MORE THAN 1 CM OF ONYX TO REFLUX BACK OVER CATHETER TIP. EXCESSIVE ONYX REFLUX MAY RESULT IN DIFFICULT CATHETER REMOVAL" AND PRECAUTIONS "UNDER SOME DIFFICULT CLINICAL SITUATIONS, RATHER THAN RISK RUPTURING THE MALFORMATION AND CONSEQUENT HEMORRHAGIC COMPLICATIONS BY APPLYING TOO MUCH TRACTION ON AN ENTRAPPED CATHETER, IT MAY BE SAFER TO LEAVE THE MICRO CATHETER IN THE VASCULAR SYSTEM." SAME EVENT AS MDR 2029214-2007-00131.

    Description of Event or Problem · 1

    TREATMENT OF AN AVM. THE AVM WAS ACCESSED WITH THE ECHELON CATHETER FROM THE LEFT SCA. IT WAS REPORTED AFTER ONYX WAS INJECTED, THERE WAS 2-3 CM OF ONYX REFLUX. THE CATHETER BECAME ENTRAPPED IN THE ONYX AND WHEN IT WAS PULLED UPON REMOVAL, IT STRAIGHTENED OUT THE VESSEL. THE SCA SEPARATED FROM THE BASILAR TIP. THE PT EXPIRED DUE TO HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX 18, AVM LIQUID EMBOLIC HCG EV3 NEUROVASCULAR 1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death