BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM STENT

    MDR report key: 1902683 · Received November 18, 2010

    Report

    Report Number
    2939204-2010-01110
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FROM THE USER FACILITY STATED THAT THE ANEURYSM WAS IN THE INTERNAL CAROTID ARTERY/POSTERIOR COMMUNICATING ARTERY AND THE ANATOMY WAS MODERATE TO HIGHLY TORTUOUS. (B)(4) FOR THE REPORTED EVENT OF PARTIAL STENT PREMATURE DEPLOYMENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INVESTIGATION AND THE INFORMATION AVAILABLE IT WAS CONCLUDED THAT OPERATIONAL CONTEXT IS THE MOST LIKELY CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    AS THE STENT WAS BEING DELIVERED TO THE LESION THE FIRST SEGMENT DEPLOYED FROM THE CATHETER. THE PHYSICIAN USED A RETRIEVAL DEVICE TO REMOVE THE STENT. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    AS THE STENT WAS BEING DELIVERED TO THE LESION THE FIRST SEGMENT DEPLOYED FROM THE CATHETER. THE PHYSICIAN USED A RETRIEVAL DEVICE TO REMOVE THE STENT. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM STENT STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - CORK M003N3EZ45200 13497848

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention MARKSMAN CATHETER (MANUFACTURER UNKNOWN)