BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1111889 · Received August 12, 2008

    Report

    Report Number
    3004742046-2008-00191
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 24, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE DEVICE REMAINS IN THE PATIENT. THE DEVICE LOT HISTORY REVIEW WAS COMPLETED. THERE ARE NO NON-CONFORMANCE ISSUES ASSOCIATED WITH THIS LOT NUMBER. THE DEVICE WAS NOT RETURNED TO ABBOTT VASCULAR FOR CONFIRMATION. A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, IT COULD BE RELATED TO OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS UTILIZED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: MISPLACED STENT. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING A RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, AN RX ACCULINK WAS PLACED IN THE DISTAL LESION. AS THE STENT WAS DEPLOYED, IT APPEARED TO MOVE FORWARD SLIGHTLY AND DID NOT COVER THE PROXIMAL 5MM OF THE LESION. THE PHYSICIAN ATTEMPTED TO PLACE A SECOND RX ACCULINK IN THE PROXIMAL PORTION OF THE LESION, BUT IT WOULD NOT ADVANCE THROUGH THE PREVIOUS STENT. THE STENT WAS REMOVED AND DISCARDED AND THE LESION WAS BALLOONED. A THIRD RX ACCULINK WAS THEN ATTEMPTED TO BE ADVANCED AND THE SAME DIFFICULTY WAS ENCOUNTERED WHICH APPEARED TO BE DUE TO A COMBINATION OF THE CONFIGURATION OF THE STENT DELIVERY CATHETER'S TIP, THE MORPHOLOGY OF THE LESION, AND THE OPEN CELL STRUCTURE OF THE INITIAL STENT. IT WAS THEN ELECTED TO USE AN XACT CAROTID STENT. THIS DEVICE HAD TO BE MANIPULATED UNDER FLUOROSCOPIC GUIDANCE AND HEAD MOVEMENTS WERE REQUIRED BEFORE IT WOULD ADVANCE TO AN OVERLAPPING POSITION, BUT IT WAS ABLE TO BE POSITIONED WITH APPROXIMATELY 50% OVERLAP ON THE INITIAL STENT AND WAS DEPLOYED WITHOUT DIFFICULTY. THERE WERE NO REPORTED PATIENT SEQUELAE. THE PATIENT WAS DISCHARGED HOME 6 DAYS POST PROCEDURE. 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 8041751

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEPARIN| RX ACCUNET| RX ACCULINK X2