BEUDAMED
    FDA Adverse Event Death Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 748497 · Received August 10, 2006

    Report

    Report Number
    3004742046-2006-00338
    Event Type
    Death
    Date Received
    August 10, 2006
    Date of Event
    June 12, 2006
    Report Date
    July 11, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    NIM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND MULTI-LINK RX PIXEL CORONARY STENT SYSTEM, PART #1005635-18J, LOT #5040431, INDICATED IN THE EVENT DESCRIPTION AND D11, IS BEING REPORTED UNDER THE SAME MANUFACTURER REPORT NUMBER. RESULTS AND CONCLUSION SUMMATION: ENGINEERING REVIEWED THE INCIDENT INFORMATION. RESTENOSIS, AS LISTED IN THE INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A STENT DELIVERY SYSTEM QUALITY PROBLEM.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOM/AE: HYPER PERFUSION SYNDROME. TIME OF SYMPTOMS/AE: TWO HOURS AFTER THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD A THREE VESSEL CORONARY BYPASS, CAROTID DEOBLITERATION OF THE LEFT, AND CAROTID OCCLUSION OF THE RIGHT. THE PATIENT HAD RESIDUAL STENOSIS AFTER THE OPERATION; SUBTOTAL OF MORE THAN 90%. THE LEFT ICA WAS STENTED. THE INTERVENTION WAS SUCCESSFUL AND THERE WERE NO PROBLEMS WITH THE DEVICE. A FEW HOURS AFTER THE INTERVENTION, THE PATIENT EXPERIENCED HYPER PERFUSION SYNDROME AND DIED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM GUIDANT ENDOVASCULAR SOLUTIONS NA 6032151

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death CROSSSAIL 3.0 X 20, OTHER:| DILATATION CATHETER: VIATRAC 14 PLUS 5.0 X 20,| RX ACCUNET 5.5