BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXSTENT MONORAIL

    MDR report key: 1068166 · Received July 1, 2008

    Report

    Report Number
    2134265-2008-01845
    Event Type
    Injury
    Date Received
    July 1, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIM
    PMA / PMN Number
    P050025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: FILTERWIRE EZ EMBOLIC SYSTEM (3.5MM - 5.5 MM). D2. COMMON DEVICE NAME: NFA DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTECTION. THE COMPLAINT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL STUDY. SAME CASE AS 2134265-2008-01850. IT WAS REPORTED THAT DURING A CAROTID ARTERY STENTING TREATMENT PROCEDURE, THE PT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA). THE LESION BEING TREATED WAS 7MM, 80% STENOSED, 25MM LONG PORTION OF THE OSTIUM RIGHT INTERNAL CAROTID ARTERY. THE PHYSICIAN TREATED THE LESION WITH PLACEMENT OF THE FILTERWIRE EZ AND THE NEXSTENT. FOLLOWING POST-DILATATION, THERE WAS 0% RESIDUAL STENOSIS. DURING THE INDEX PROCEDURE, THE SITE REPORTED THE PT EXPERIENCED A TIA. THE NEUROLOGIST WAS CONSULTED. NO MR OR CT SCAN WAS PERFORMED. THERE WAS NO STENT FAILURE/MALFUNCTION RELATED TO THE FILTERWIRE EZ BEING DELIVERED OR DEPLOYED AT THE INTENDED LOCATION, AND THE STENT DELIVERY CATHETER WAS DELIVERED SUCCESSFULLY. THE PT WAS DISCHARGED THE NEXT DAY ON PLAVIX AND ASPIRIN. IN THE OPINION OF THE PHYSICIAN, THE RELATIONSHIP OF THE TIA TO BE POSSIBLY RELATED TO THE FILTERWIRE AND NEXSTENT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXSTENT MONORAIL NIM STENT, CAROTID NIM BOSTON SCIENTIFIC NA C80402

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization