BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM3 MICRODELIVERY STENT SYSTEM

    MDR report key: 666291 · Received January 19, 2006

    Report

    Report Number
    6000078-2006-00010
    Event Type
    Death
    Date Received
    January 19, 2006
    Date of Event
    December 12, 2005
    Report Date
    January 18, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION
    Product Code
    NJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CORPORATION REPORTED THAT DURING COILING OF A BASILAR TIP ANEURYSM, THE SUBJECT DEVICE DEPLOYED IN ANOTHER AREA AND THE DR WAS UNABLE TO PROCEED WITH THE PROCEDURE AND THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM3 MICRODELIVERY STENT SYSTEM INTRAVASCULAR STENT NJE BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION * 8052990

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR