BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX ANEURYSM

    MDR report key: 4659408 · Received April 3, 2015

    Report

    Report Number
    2029214-2015-00317
    Event Type
    Death
    Date Received
    April 3, 2015
    Date of Event
    July 8, 2008
    Report Date
    March 5, 2015
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OBA
    PMA / PMN Number
    H060003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/19404128 THIS REPORT WAS CREATED TO CAPTURE THE DEATH RELATED TO THE ONYX. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, AS IT WAS CONSUMED IN THE EVENT; THEREFORE THE EVENT CAUSE COULD NOT BE DETERMINED. THE LOT HISTORY RECORD REVIEW WAS NOT POSSIBLE SINCE THE LOT NUMBERS WERE NOT REPORTED. (B)(4).

    Description of Event or Problem · 1

    CITATION: RONIE PESKE ET AL. EVALUATION OF ONYX HD-500 EMBOLIC SYSTEM IN THE TREATMENT OF 84 WIDE NECK INTRACRANIAL ANEURYSMS. NEUROSURGERY VOL. 64 NUMBER 5. MAY 2009. MEDTRONIC (COVIDIEN) RECEIVED INFORMATION THROUGH LITERATURE REVIEW AND THE FOLLOWING EVENT(S) WERE CAPTURED AS A RESULT OF THE REVIEW: CLINICAL COMPLICATIONS INCLUDED TWO DEATHS RELATED TO THE PROCEDURE (NONE OF THESE WERE INCIDENTAL ANEURYSMS). A PATIENT WAS TREATED 48 HOURS AFTER SAH (SUBARACHNOID HEMORRHAGE) (FISHER GRADE 3, HH GRADE IV), WITHOUT RECEIVING ANTIPLATELET BEFORE OR AFTER THE PROCEDURE. FOUR HOURS LATER, NEUROLOGICAL AND CLINICAL DETERIORATION PROMPTED A HEAD COMPUTED TOMOGRAPHIC SCAN, WHICH SHOWED EXTENSIVE IPSILATERAL EDEMA AND HYPODENSITY, AND DSA, WHICH SHOWED IPSILATERAL INTERNAL CAROTID ARTERY THROMBOSIS. SUCCESSFUL RECANALIZATION WAS ACHIEVED WITH BALLOON ANGIOPLASTY AND INTRAVENOUS ADMINISTRATION OF REPPRO. THE PATIENT DIED 9 DAYS LATER AS A RESULT OF EXTENSIVE IPSILATERAL RECURRENT STROKES AND SEPSIS.ALL PROCEDURES WERE PERFORMED UNDER GENERAL ANESTHESIA, CONTINUOUS CARDIORESPIRATORY MONITORING, AND INVASIVE ARTERIAL PRESSURE MONITORING. INFORMATION RECEIVED FROM THE SAME ARTICLE AS MFR REPORT #S 2029214-2015-00326 2029214-2015-00337

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223914 ONYX ANEURYSM POLYMERIZING, NEUROVASCULAR EMBOLIZATION MATERIAL OBA COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death| O| R