BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX ANEURYSM

    MDR report key: 2076802 · Received May 4, 2011

    Report

    Report Number
    2029214-2011-00093
    Event Type
    Death
    Date Received
    May 4, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 12, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    MFE
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE CONSUMED IN THE EVENT. (B)(4). MODEL# AND LOT# OF OTHER ONYX INVOLVED: MODEL#: 105-8101-500; LOT# 7473807; DOM: 5/21/2009; EXPIRATION: 10/1/2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ADMITTED TO HOSPITAL AFTER EXPERIENCING STROKE-LIKE SYMPTOMS ON (B)(6) 2011. THE PATIENT WAS DIAGNOSED WITH A LARGE INTRACRANIAL LEFT INTERNAL CAROTID ARTERY ANEURYSM, FOR WHICH SHE SUBSEQUENTLY UNDERWENT SUCCESSFUL ONYX EMBOLIZATION ON (B)(6) 2011. FINAL ANGIOGRAM REVEALED 90% ANEURYSM OCCLUSION AND A SLIGHT EXTENSION OF THE ONYX MATERIAL WENT INTO THE PARENT VESSEL. ALTHOUGH THE EXTENSION WAS MINIMAL, THERE WAS SOME CONCERN DUE TO A PRE-EXISTING NARROWING OF THE BLOOD VESSEL. ON (B)(6) 2011, AFTER AN EXTENSIVE EPISODES OF EMESIS, THE PATIENT DEVELOPED SPEECH DIFFICULTIES AND RIGHT- SIDED WEAKNESS. NEW ANGIOGRAPHIC FINDINGS SHOWED THAT THE ONYX MATERIAL HAD SHIFTED AND RESULTED IN FURTHER NARROWING OF THE BLOOD VESSEL. ENDOVASCULAR REVASCULARIZATION WAS ATTEMPTED BUT DEEMED NOT POSSIBLE. AFTER THE PROCEDURE, THE PATIENT INITIALLY REMAINED STABLE, BUT THEN LATER DEVELOPED DIFFICULTIES MAINTAINING HER BLOOD PRESSURE ENOUGH TO KEEP HER BRAIN PERFUSE. THE PHYSICIAN DISCUSS WITH THE FAMILY REGARDING THE PATIENT'S CONDITION AND PROGNOSIS. THE PATIENT'S FAMILY MADE FINAL DECISION NOT TO RESUSCITATE. SUBSEQUENTLY, THE PATIENT EXPIRED FEW HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX ANEURYSM LIQUID EMBOLIC MFE EV3 NEUROVASCULAR 105-8101-500 7614157

    Patients

    Seq Age Sex Outcome Treatment
    1 Death