BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXSTENT MONORAIL

    MDR report key: 935302 · Received October 30, 2007

    Report

    Report Number
    6000093-2007-02062
    Event Type
    Injury
    Date Received
    October 30, 2007
    Date of Event
    September 26, 2007
    Report Date
    October 3, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIM
    PMA / PMN Number
    K032884
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PATIENT AND THE DELIVERY DEVICE HAS BEEN DISPOSED; THEREFORE, NO DIRECT PRODUCT ANALYSIS WILL BE AVAILABLE. AS NO DEVICE WAS RECEIVED FOR ANALYSIS, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE DIFFICULTIES EXPERIENCED WITH THIS COMPLAINT INCIDENT.

    Description of Event or Problem · 1

    CLINICAL STUDY. SAME CASE AS 2954755-2007-00043. IT WAS REPORTED THAT 1 DAY AFTER A TREATMENT WITH THE NEXSTENT CAROTID STENT SYSTEM, THE PATIENT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA). THE TARGET LESION WAS LOCATED IN THE LEFT PROXIMAL INTERNAL CAROTID ARTERY (1ST SEPTAL), AND HAD A DIAMETER OF 6.0MM, 14.0MM LENGTH AND 85% STENOSIS. PRE-DILATATION AFTER EMBOLIC PROTECTION PLACEMENT AND BEFORE STENT PLACEMENT WAS PERFORMED. THE PHYSICIAN THEN PLACED A 4-9MM X 30MM SIZE NEXSTENT STENT WAS IMPLANTED. POST-DILATATION WAS PERFORMED AND RESIDUAL STENOSIS WAS 0%. NO NEUROLOGICAL DEFICITS WERE IDENTIFIED PERI-PROCEDURALLY. ONE DAY POST INDEX PROCEDURE, PATIENT EXPERIENCED A TIA. NO THERAPEUTIC MEASURES WERE ADMINISTERED. CT WAS PERFORMED AND SHOWED NO ACUTE FINDINGS. HOSPITALIZATION WAS PROLONGED, AND PATIENT WAS DISCHARGED THE NEXT DAY WITH AN OUTCOME OF RESOLVED WITHOUT RESIDUAL EFFECTS. THE PHYSICIAN NOTED THE EVENT TO BE POSSIBLY RELATED TO THE NEXSTENT & FILTERWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXSTENT MONORAIL NIM STENT, CAROTID NIM BOSTON SCIENTIFIC NA C64703

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization