BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXSTENT MONORAIL

    MDR report key: 960307 · Received December 6, 2007

    Report

    Report Number
    6000093-2007-02279
    Event Type
    Injury
    Date Received
    December 6, 2007
    Date of Event
    October 27, 2007
    Report Date
    November 8, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIM
    PMA / PMN Number
    P050025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: 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 2954755-2007-00047. IT WAS REPORTED THAT 17 DAYS AFTER A CAROTID ARTERY STENTING PROCEDURE, THE PATIENT HAD A CEREBROVASCULAR ACCIDENT (CVA). THE INDEX PROCEDURE TREATED A 5.5X20MM, 90% STENOSED LESION IN THE LEFT PROXIMAL INTERNAL CAROTID ARTERY WITH A 4-9X30MM NEXSTENT CAROTID STENT. THE LESION WAS PROTECTED BY A FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM. POST-DILATATION WAS PERFORMED AND RESIDUAL STENOSIS WAS 25%. THE PATIENT WAS DISCHARGED THE NEXT DAY. DISCHARGE MEDICATION WAS UNK AT THIS TIME. SEVENTEEN DAYS POST INDEX PROCEDURE, THE PATIENT HAD A CVA. THE PATIENT PRESENTED WITH CONFUSION, DIFFICULTY WITH SPEECH, FACIAL DROOP, ATRIAL FIBRILLATION, HYPOTENSION, RENAL INSUFFICIENCY (RI), AND URINARY TRACT INFECTION (UTI). ELECTROLYTES WERE REPLACED AND FLUID WAS RESUSCITATED. THEN THE PATIENT HAD SIGNS AND SYMPTOMS OF VOLUME OVERLOAD. THE PATIENT WAS ON ORAL MEDICATIONS FOR DIABETES MELLITUS II. THE CAROTID STUDY SHOWED THE STENT IS PATENT. ACTIONS TAKEN INCLUDED: UNSPECIFIED MEDICATION GIVEN, ELECTROCARDIOGRAM (EKG), LABS WITH URINALYSIS, CHEST X-RAY, COMPUTERIZED TOMOGRAPHY (CT) HEAD WITHOUT CONTRAST, AND CAROTID DUPLEX AND TRANSCRANIAL DOPPLER. HOWEVER, SPECIFIC RESULTS WERE NOT PROVIDED AT THIS TIME. THE OUTCOME OF THE EVENT WAS UNK AT THIS TIME. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 4 DAYS LATER. DISCHARGE MEDICATIONS WERE UNK. TWENTY FIVE DAYS POST INDEX PROCEDURE, THE PATIENT HAD NAUSEA AND VOMITING. THE PATIENT WAS ADMITTED 2 DAYS LATER AND UNSPECIFIED MEDICATION WAS GIVEN. ACTIONS TAKEN INCLUDED LABS AND COMPUTERIZED TOMOGRAPHY (CT) HEAD WITHOUT CONTRAST. PLASMA RED BLOOD CELLS (PRBC) WERE TRANSFUSED DUE TO ANEMIA. THE EVENT WAS NOT RESOLVED. THE PATIENT WAS DISCHARGED 3 DAYS AFTER ADMISSION. PER INVESTIGATOR, BOTH EVENTS WERE POSSIBLY RELATED TO THE NEXSTENT CAROTID STENT AND FILTERWIRE EZ SYSTEM. NO ADD'L INFO WAS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXSTENT MONORAIL NIM STENT, CAROTID NIM BOSTON SCIENTIFIC CORP. 4-9X30MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| L| R