BEUDAMED
    FDA Adverse Event Death Summary report: N

    HYPERFORM OCCLUSION BALLOON

    MDR report key: 507021 · Received January 16, 2004

    Report

    Report Number
    2029214-2004-00002
    Event Type
    Death
    Date Received
    January 16, 2004
    Report Date
    December 16, 2003
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    MJN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A RIGHT MCA STROKE TWO DAYS AFTER LUNG SURGERY, CTA/CT PERFUSION INDICATED A LARGE INFARCT. DUE TO THE PREVIOUS SURGERY, USE OF IV TPA WAS NOT AN OPTION. INTRA-ARTERIAL TISSUE PLASMINOGEN ACTIVATOR WAS PLACED IN THE CLOT WITHOUT FLOW. THE RETRIEVAL DEVICE WAS DEPLOYED. FLOW WAS NOT INITIALLY RESTORED, BUT MINIMAL FLOW WAS EVENTUALLY OBSERVED. A GUIDEWIRE AND THE BALLOON CATHETER WERE USED. THE BALLOON WAS INFLATED DURING THE USE. THE PHYSICIAN BELIEVES THAT THE GUIDEWIRE BECAME EXTRALUMINAL AND THE BALLOON FOLLOWED, BUT VISUALIZATION WAS LIMITED DUE TO THE CLOT. FOLLOW-UP ANGIOGRAPHY SHOWED EXTRAVASATION FROM THE VESSEL. THERE WAS NO REPORT THAT THE DEVICE MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERFORM OCCLUSION BALLOON OCCLUSION BALLOON MJN MICRO THERAPEUTICS, INC. 104-4470 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death TRANSEND-10 GUIDEWIRE.