BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 827667 · Received February 9, 2007

    Report

    Report Number
    6000078-2007-00046
    Event Type
    Malfunction
    Date Received
    February 9, 2007
    Date of Event
    January 18, 2007
    Report Date
    January 18, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIV
    Product Code
    NJE
    PMA / PMN Number
    H020002 / s4
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H020002 / S5.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC ON 01/18/2007 THAT "DURING PROCEDURE, (THE PHYSICIAN) COULD NOT GET THE STABILIZER (COMPONENT OF DEVICE IN QUESTION) TO ADVANCE ONCE THE STENT (DEVICE IN QUESTION) WAS IN POSITION, SO HE WAS UNABLE TO DEPLOY THE (DEVICE IN QUESTION). THE STABILIZER ENDED UP BREAKING OFF AT THE PROXIMAL END DUE TO THE FORCE NEEDED TO ATTEMPT TO DEPLOY THE (DEVICE IN QUESTION). WHEN HE REMOVED THE DELIVERY SYSTEM, HE ALSO NOTICED A TEAR IN THE DELIVERY CATHETER (COMPONENT OF DEVICE IN QUESTION). HE THEN USED ANOTHER STENT OF THE SAME SIZE, WHICH HE WAS ABLE TO DEPLOY, BUT IT WAS VERY DIFFICULT. HE DID MENTION THAT THERE WAS EXTREME TORTUOSITY IN THE PT'S CAROTID. HE WAS USING A 200CM GUIDEWIRE WHEN TRYING TO DEPLOY THE (DEVICE IN QUESTION)." IT WAS REPORTED THAT THE ANEURYSM COILING PROCEDURE OF THE INTERNAL CAROTID ARTERY WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE, THAT THERE WERE NO PT COMPLICATIONS, AND THAT THE PT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM NJE - STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIV SNF34530 8397195

    Patients

    Seq Age Sex Outcome Treatment
    1 * TRANSEND GUIDEWIRE, THERAPY DATE