BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 1040257 · Received May 7, 2008

    Report

    Report Number
    2939204-2008-00165
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 7, 2008
    Report Date
    April 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NJE
    PMA / PMN Number
    H020002/S4
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INFO IS UNK AS DEVICE BATCH/LOT NUMBER HAS NOT BEEN PROVIDED TO THE MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR THAT A CUSTOMER ENCOUNTERED DIFFICULTIES DURING USE OF A STENT. ACCORDING TO THE CUSTOMER: "FRICTION WAS ENCOUNTERED BETWEEN THE STENT DELIVERY SYSTEM AND THE GUIDE WIRE. THE ENTIRE SYSTEM (E.G. GUIDE WIRE AND STENT SYSTEM) WAS ADVANCED, BUT COULD NOT BE CONTROLLED DUE TO FRICTION. THE PHYSICIANS DECIDED TO REMOVE THE ENTIRE SYSTEM FROM THE PT. THE FRICTION IN THE SYSTEM WAS HIGH, SO THEY HAD TO USE QUITE A LOT OF FORCE TO MOVE THE ENTIRE SYSTEM. A BIT PROXIMAL IN THE ICA (INTERNAL CAROTID ARTERY) THE STENT (SUBJECTED DEVICE) UNEXPECTEDLY STARTED TO DEPLOY, SO THE PHYSICIANS DEPLOYED IT SAFELY AND USED ANOTHER STENT TO COMPLETE THE STENTING OF THE ANEURYSM NECK. THERE WERE NO PT COMPLICATIONS".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention