BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1083442 · Received July 29, 2008

    Report

    Report Number
    3004742046-2008-00178
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    May 27, 2008
    Report Date
    July 8, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE STENT REMAINS IN THE PT. THE LOT NUMBER WAS PROVIDED. THE CAUSE OF THE MISPLACEMENT OF THE STENT BY THE OPERATOR IS UNK, HOWEVER; THE INSTRUCTIONS FOR USE FOR THE RX ACCULINK STATES ON THE WARNING SECTION: "ENSURE OPTIMAL POSITIONING OF THE STENT PRIOR TO DEPLOYMENT". FROM THE LIMITED INCIDENT INFO, THE EVENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT IN WHICH THE DEVICE WAS UTILIZED AND NOT A MFG RELATED ISSUE. THE LOT HISTORY RECORD WAS REVIEWED AND THERE ARE NO NON-CONFORMANCES ASSOCIATED WITH THIS LOT NUMBER.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: MISPLACED STENT. TIME OF MALFUNCTION: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID ARTERY (LICA) STENTING PROCEDURE, DURING DEPLOYMENT OF THE STENT, THE STENT WAS MISPLACED BY THE OPERATOR. THE LESION WAS NOT COMPLETELY COVERED, SO A SECOND STENT WAS DEPLOYED TO FULLY COVER THE LESION. AFTER PLACEMENT OF THE SECOND STENT, IT WAS NOTED THAT THERE WAS SOME DISTAL KINKING OR SPASMING OF THE VESSEL. THE PHYSICIAN WAS UNSURE IF IT WAS STENOSIS, VESSEL DISSECTION, OR TORTUOSITY. A THIRD STENT WAS INSERTED INTO THE VASCULATURE, BUT THE PHYSICIAN DECIDED NOT TO PLACE IT BECAUSE OF THE NATURE OF THE KINK. THE PHYSICIAN DECIDED TO REMOVE THE STENT RATHER THAT DEPLOY IT AND REMOVE THE EMBOLIC PROTECTION DEVICE. AT THIS POINT, THE VESSEL RELAXED AND THERE WAS NO EVIDENCE OF DISSECTION OR ADD'L STENOSIS. THERE WERE NO ADVERSE PT SEQUELAE REPORTED. TWO DAYS POST PROCEDURE, THE PT WAS DISCHARGED TO HOME. ALTHOUGH REQUESTED, THERE IS NO ADD'L INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 8032451

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RX ACCULINK STENT| HEPARIN| RX ACCUNET EMBOLIC PROTECTION DEVICE| S'PORT WIRE