BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 933653 · Received October 24, 2007

    Report

    Report Number
    6000078-2007-00267
    Event Type
    Injury
    Date Received
    October 24, 2007
    Date of Event
    September 24, 2007
    Report Date
    September 24, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    NJE
    PMA / PMN Number
    H020002/S4
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: H020002/S5.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER THAT A CUSTOMER ENCOUNTERED PROBLEMS DURING USE OF A STENT. ACCORDING TO THE CUSTOMER: "THE STENT [DEVICE IN QUESTION] WAS DEPLOYED AT THE C1 TO C2 SECTION OF ICA (INTERNAL CAROTID ARTERY). UPON STENT DELIVERY SYSTEM WITHDRAWAL POST IMAGE CAPTURE THE STENT WAS NOTICED TO HAVE MOVED FROM THE AREA OF DEPLOYMENT TO THE PETROUS SECTION. THE FOUR DISTAL MARKERS AND THE FOUR PROXIMAL MARKERS WERE PRESUMED TO HAVE FOLDED OVER SUCH THAT THE STENT WAS 'FOLDED OVER ON ITSELF'. INTERVENTION USE OF A 4MM MICROSNARE WAS USED TO RETRIEVE THE STENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM NJE: STENT (INTRACRANIAL NEUROVASCULAR) NJE BOSTON SCIENTIFIC CORP SNF34520 9727387

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention