BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 943057 · Received April 13, 2007

    Report

    Report Number
    6000078-2007-00113
    Event Type
    Malfunction
    Date Received
    April 13, 2007
    Date of Event
    March 22, 2007
    Report Date
    March 23, 2007
    Manufacturer
    BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION
    Product Code
    NJE
    PMA / PMN Number
    h020002/s4
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510 (K): H020002/S5.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO PUSH THE INTRACRANIAL STENT UP TO A LESION IN THE DISTAL INTERNAL CAROTID ARTERY (ICA), BUT WAS UNABLE TO PASS IT DUE TO THE PT'S TORTUOUS ANATOMY. THE INTRACRANIAL STENT REPORTEDLY STRAIGHTENED OUT AT THE CAVERNOUS SEGMENT. THE PHYSICIAN TRIED TO APPROACH THE LESION AGAIN WITH A DIFFERENT INTRACRANIAL STENT WHICH PUSHED THE PREVIOUS STENT INTO THE DISTAL ICA. THE PHYSICIAN THEN WITHDREW THE SECOND INTRACRANIAL STENT. THE PT REPORTEDLY SUFFERED NO ADVERSE EFFECTS AS A RESULT OF THIS PHENOMENON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM (NJE) INTRACRANIAL STENT NJE BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION SNF34020 9357356

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR