BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXSTENT MONORAIL

    MDR report key: 1022008 · Received March 31, 2008

    Report

    Report Number
    2134265-2008-00919
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIM
    PMA / PMN Number
    P050025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE STENT REMAINS IN THE PATIENT AND THE DELIVERY DEVICE HAS BEEN DISPOSED, THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE SHOP FLOOR PAPERWORK FOR THIS BATCH SHOWS THAT THE PRODUCT MET ITS SPECIFICATIONS. THE PROBABLE ROOT CAUSE OF THIS INCIDENT CAN NOT BE DETERMINED HOWEVER THE OCCURRENCE OF THESE EVENTS IS MOST OFTEN RELATED TO PATIENT FACTORS SUCH AS LESION MORPHOLOGY, VESSEL ANATOMY, RESISTANCE TO HEPARIN, AND CLOTTING DISORDERS. THEREFORE, THE ROOT CAUSE WILL BE CLASSIFIED AS ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    CLINICAL TRIAL. IT WAS REPORTED THAT AFTER THE CAROTID STENTING INDEX PROCEDURE, THE PATIENT HAD A TRANSIENT ISCHEMIC ATTACK (TIA). THE INDEX PROCEDURE TREATED A 6.0X12MM, 80% STENOSED LESION IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY WITH A PLACEMENT OF A FILTERWIRE EZ SYSTEM AND CAROTID STENTING OF A 4-9X30MM NEXSTENT. POST-DILATATION WAS PERFORMED AND THERE WAS 0% RESIDUAL STENOSIS. POST INDEX PROCEDURE, THE PATIENT HAD A TIA. A POST PROCEDURAL NEUROLOGICAL EXAMINATION PERFORMED THE NEXT DAY NOTED THAT THE PATIENT HAD EXPERIENCED SOME PARESTHESIAS AND SOME FINE MOTOR DIFFICULTY IN THE RIGHT HAND DURING THE NIGHT. THE SYMPTOMS HAD RESOLVED AND THE PATIENT WAS DOING WELL. THE PATIENT WAS DISCHARGED 2 DAYS POST INDEX PROCEDURE. THE OUTCOME OF THE EVENT WAS RESOLVED WITHOUT RESIDUAL EFFECTS. THE PHYSICIAN ASSESSED THIS EVENT AS PROBABLY RELATED TO THE NEXSTENT AND THE PROCEDURE, BUT NOT RELATED TO THE FILTERWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXSTENT MONORAIL NIM STENT, CAROTID NIM BOSTON SCIENTIFIC NA C73003

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization