BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM STENT

    MDR report key: 1854426 · Received October 5, 2010

    Report

    Report Number
    2939204-2010-00968
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE STENT WAS RETURNED FOR ANALYSIS, THE DELIVERY SYSTEM WAS NOT RETURNED. VISUAL INSPECTION OF THE STENT FOUND THE STRUTS WERE TANGLED. THE STRUTS WERE UNTANGLED IN THE LABORATORY AND NO OTHER ANOMALIES WERE NOTED TO THE STENT. THE CAUSE OF THE PREMATURE DEPLOYMENT CANNOT BE DETERMINED. FROM THE INFORMATION AVAILABLE THERE IS NO INDICATION THAT MISUSE OR MISHANDLING CONTRIBUTED TO THE EVENT. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE MOST PROBABLE CAUSE OF THE PREMATURE DEPLOYMENT OR THE CAUSE OF THE TANGLED STENT STRUTS. THEREFORE, THE ROOT CAUSE FOR THE REPORTED EVENT AND THE OBSERVED ANOMALY IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT DEPLOYED INSIDE THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT WITH NO CLINICAL CONSEQUENCE TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT DEPLOYED INSIDE THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT WITH NO CLINICAL CONSEQUENCE TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM STENT STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - FREMONT M003SNF345300

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCATHETER (MODEL AND MANUFACTURER UNKNOWN)