BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1241277 · Received November 21, 2008

    Report

    Report Number
    3004742046-2008-00285
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    November 1, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT. OCCLUSION OF STENTED SEGMENT AND STROKE MAY OCCUR DURING THIS TYPE OF PROCEDURE AS LISTED IN THE DEVICE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: STENT OCCLUSION/STROKE. TIME OF SYMPTOMS/AE: 25 DAYS POST PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY 25 DAYS POST AN EVENTFUL LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE PATIENT PRESENTED TO THE ER WITH RIGHT UPPER EXTREMITY WEAKNESS AND NUMBNESS, FACIAL NUMBNESS AND DYSARTHRIA. THE SYMPTOMS BEGAN TO RESOLVE WITHIN ONE HOUR. THE PATIENT WAS TREATED WITH AGGRENOX, HEPARIN DRIP AND COUMADIN. THE SYMPTOMS IMPROVED SLOWLY THROUGHOUT THE DAY AND BY THE EVENING, THE PATIENT HAD USE OF THE RIGHT ARM, NORMAL SPEECH, AND THE FACIAL DYSFUNCTION HAD RESOLVED. A CT ANGIOGRAM SHOWED THE STENT WAS NARROWED IN THE MID PORTION WITH A LUMINAL DIAMETER OF APPROX. 2 MM. IT WAS REPORTED THAT THIS MAY BE DUE TO EARLY STENT THROMBOSIS, PERHAPS DUE TO ASPIRIN OR PLAVIX RESISTANCE, OR IT IS PLAQUE EXTRUSION THROUGH STENT STRUTS; NEITHER HAS BEEN CONFIRMED. THE PATIENT CONTINUED TO HAVE MILD RESIDUAL SYMPTOMS THROUGHOUT THE HOSPITAL STAY AND WAS DIAGNOSED WITH A STROKE. THE PATIENT WAS DISCHARGED TO HOME 10 DAYS LATER. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 8081151

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R| S