BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIUM PLATINUM 3D

    MDR report key: 4103317 · Received September 19, 2014

    Report

    Report Number
    2029214-2014-00544
    Event Type
    Death
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    IRVINE
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IN THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A NON-RUPTURED BI-LOBED ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY. THE PATIENT WAS NOT ON DUAL ANTIPLATELET THERAPY BEFORE, DURING, OR AFTER THE PROCEDURE. FIVE DAYS PRIOR TO THE PROCEDURE, THE PATIENT HAD A TRACHEOSTOMY AND DECOMPRESSIVE CRANIOTOMY DUE TO HYDROCEPHALY, PROLONGED, OROTRACHEAL INTUBATION, AND FAILURE IN THE VENTILATOR WEANING. ON (B)(6) 2014, THE PATIENT UNDERWENT COILING EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THE IMPLANT COIL PREMATURELY DETACHED AS IT WAS ADVANCED INTO THE ANEURYSM WITH APPROXIMATELY 10CM OF THE COIL LEFT. AN ATTEMPT WAS MADE TO RECOVER THE COIL, BUT IT MOVED TO THE MIDDLE CEREBRAL ARTERY. A DECREASE IN BLOOD FLOW WAS NOTICED IN THE RIGHT ANTERIOR CEREBRAL ARTERY AND THE RIGHT MIDDLE CEREBRAL ARTERY. THE COIL COULD NOT BE RECOVERED AND REMAINED INSIDE THE PATIENT. ON (B)(6) 2014, THE PATIENT EXPIRED. THE PHYSICIAN BELIEVES THE CAUSE OF DEATH WAS DUE TO SEPSIS AND HYDROCEPHALY, WHICH WAS THE CAUSE OF IMPAIRMENT AND ENTRANCE TO THE HOSPITAL. THERE WAS NO RUPTURE OF THE ANEURYSM DURING OR AFTER THE PROCEDURE. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583702 AXIUM PLATINUM 3D DETACHABLE COIL HCG IRVINE QC-8-30-3D 9855294

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death| S