BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLITAIRE FR

    MDR report key: 3113723 · Received May 15, 2013

    Report

    Report Number
    2029214-2013-00458
    Event Type
    Death
    Date Received
    May 15, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 19, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPDATING MDR WITH ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013 STATING THAT THE CAUSE OF DEATH WAS DUE TO A STROKE AND BRAIN SWELLING.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A STROKE AT THE LEFT M1 M2. IT WAS REPORTED THAT THE PATIENT UNDERWENT A SUCCESSFUL MECHANICAL THROMBECTOMY A COUPLE OF WEEKS AGO WITHOUT BEING HEPARINIZED AFTERWARDS DUE TO HER PRECEDING CLINICAL COURSE AND THE SUSPICION THAT SHE HAD AN INFARCTED VOLUME IN THE AFFECTED TERRITORY. SHE WAS IMPROVING CLINICALLY; HOWEVER, SHE DETERIORATED WITHIN 12-18 HOURS OF THE SUCCESSFUL RECANALIZATION. A REPEATED CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY) SHOWED AN M1 PLUG IN THE SAME LOCATION, BUT MORE PROXIMAL AND MORE EXTENSIVE THAN THE ORIGINAL OCCLUSION WITH WORSE FILLING OF COLLATERALS. ANOTHER SUCCESSFUL RECANALIZATION PROCEDURE WAS PERFORMED ON THE PATIENT, BUT THE PATIENT WAS ASSUMED TO BE HYPERCOAGULABLE DUE TO THE CANCER AND THERE MUST HAVE BEEN IN SITU THROMBOSIS AT THE SITE OF THE SOLITAIRE DEPLOYMENT. IT WAS ALSO BELIEVED THAT THERE WAS DAMAGE TO THE INTIMA WHEREVER THE SOLITAIRE PASSED THROUGH THE INTRACEREBRAL ARTERY. IT WAS REPORTED THAT THE SECOND OCCLUSION CAUSED THE PATIENT TO DEVELOP AN INFARCTION OF THE MCA (MIDDLE CEREBRAL ARTERY) AND SHE WAS DISCHARGED TO HOSPICE IN CRITICAL CONDITION. SUBSEQUENTLY, IT WAS REPORTED THAT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215584 SOLITAIRE FR FLOW RESTORATION NRY EV3 NEUROVASCULAR SFR-4-20 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death