BEUDAMED
    FDA Adverse Event Death Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 990161 · Received January 30, 2008

    Report

    Report Number
    3004742046-2008-00021
    Event Type
    Death
    Date Received
    January 30, 2008
    Date of Event
    August 1, 2007
    Report Date
    January 2, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTACHMENT: CARLOS H. TIMARAN, ERIC B. ROSERO, R. JAMES VALENTINE, J. GREGORY MODRALL, STEPHEN SMITH, AND G. PATRICK CLAGETT; "ACCURACY AND UTILITY OF THREE-DIMENSIONAL CONTRAST-ENHANCED MAGNETIC RESONANCE ANGIOGRAPHY IN PLANNING CAROTID STENTING" JOURNAL OF VASCULAR SURGERY 2007; 46:257-264. THE DEVICE REMAINED IN THE PT AND WAS NOT AVAILABLE FOR EVAL. THE LOT # WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. TIME OF SYMPTOMS/AE: AFTER A CAROTID ARTERY STENTING PROCEDURE. SYMPTOMS/AE: DEATH. THE FOLLOWING EVENT WAS NOTED THROUGH A PERIODIC ARTICLE REVIEW. THE ARTICLE DESCRIBES A 96 PT SERIES OF CAROTID ARTERY STENTS THAT WERE IMPLANTED USING THE ABBOTT ACCULINK, BOSTON CAROTID WALLSTENT, AND CORDIS PRECISE. THE STENTS WERE USED WITH DISTAL EMBOLIZATION PROTECTION DEVICES. REPORTEDLY, ONE PT DIED AT HOME SIX DAYS AFTER AN UNEVENTFUL STENTING PROCEDURE, PRESUMABLY FROM A MYOCARDIAL INFARCTION. THE INVESTIGATOR LEARNED ABOUT THE DEATH WHEN THE PT FAILED TO SHOW UP FOR A F/U DUPLEX. THIS DEATH WILL BE CONSERVATIVELY FILED/REPORTED AS 83% OF THE DEVICES IMPLANTED WERE ABBOTT DEVICES. NO ADD'L INFO WAS AVAILABLE.

    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 64 YR Death INJECTED ANTECUBITAL VEIN| 7%=4 CORDIS PRECISE| STENT: 83%=50 ABBOTT RX ACCULINK| 10%=6 BOSTON CAROTID WALLSTENT| OTHER: 20ML GADOLINIUM-BASED CONTRAST