BEUDAMED
    FDA Adverse Event Death Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 1402551 · Received June 12, 2009

    Report

    Report Number
    3004742046-2009-00146
    Event Type
    Death
    Date Received
    June 12, 2009
    Date of Event
    October 16, 2008
    Report Date
    May 21, 2009
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT INVOLVES A STUDY NOTED IN AN ARTICLE. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS AND DEVICE INVESTIGATION COULD NOT BE PERFORMED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. THE REPORTED EVENTS ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE DEVICE. ATTACHMENT: MD ET AL: "OPEN-CELL VERSUS CLOSED-CELL STENT DESIGN DIFFERENCES IN BLOOD FLOW VELOCITIES AFTER CAROTID STENTING", PUBLISHED J VASC SURG 2009, 49: 602-6. DEVICE #2 - XACT PART/LOT UNK, REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    DEVICE# 1 MALFUNCTION: NONE. SYMPTOMS/AE: STROKE/DEATH. TIME OF SYMPTOMS/AE: DURING 30 DAY FOLLOW-UP. THE FOLLOWING EVENTS WERE NOTED THROUGH A PERIODIC ARTICLE REVIEW. A SERIES OF 141 CAROTID ARTERY STENTING (CAS) PROCEDURES WERE PERFORMED IN 139 PTS OVER A PERIOD OF 3 YEARS. THE RX ACCULINK STENT WAS IMPLANTED IN 77 PTS AND THE XACT STENT WAS IMPLANTED IN AN UNSPECIFIED NUMBER OF PTS. THE PURPOSE OF THE SERIES WAS TO IDENTIFY POSSIBLE STENT DESIGN DIFFERENCES IN CAROTID VELOCITIES. SUCCESSFUL REVASCULARIZATION WAS ACHIEVED IN ALL CASES. THE 30-DAY STROKE-DEATH RATE IN THIS SERIES WAS 1.6%. THE ARTICLE DOES NOT DIRECTLY CORRELATE THE ADVERSE OUTCOMES TO A SPECIFIC DEVICE/BRAND/MANUFACTURER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death PROTEGE| PRECISE| STENT: WALLSTENT| NEXSTENT| XACT