BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 1052016 · Received May 21, 2008

    Report

    Report Number
    2939204-2008-00181
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 26, 2008
    Report Date
    April 26, 2008
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORP
    Product Code
    NJE
    PMA / PMN Number
    K020002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN UNANSWERED TO DATE. BASED ON THE INFORMATION KNOWN AT THIS TIME, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN 2008, A STENT ASSISTED COILING PROCEDURE OF A LEFT INTERNAL CAROTID ARTERY ANEURYSM. WHILE ATTEMPTING TO DEPLOY THE SUBJECT DEVICE (STENT), THE OUTER SHAFT FRACTURED. RESISTANCE WAS NOTED WHEN REMOVING THE SUBJECT DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THE PATIENT WAS STABLE POST PROCEDURE AND DID NOT SUFFER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM NJE - STENT, INTRACRANIAL NEUROVASCULAR NJE NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR GUIDEWIRE (UNKNOWN MFG)