BEUDAMED
    FDA Adverse Event Death Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1032383 · Received April 22, 2008

    Report

    Report Number
    9616695-2008-00050
    Event Type
    Death
    Date Received
    April 22, 2008
    Date of Event
    February 14, 2008
    Report Date
    March 28, 2008
    Manufacturer
    ABBOTT VASCULAR GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: DEATH. TIME OF SYMPTOMS/AE: AFTER THE PROCEDURE. IT WAS REPORTED THAT 6 DAYS POST AN UNEVENTFUL RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE PATIENT EXPIRED FROM AN ACUTE MYOCARDIAL INFARCTION. THE PATIENT HAD A SIGNIFICANT CARDIAC HISTORY AND WAS SCHEDULED TO UNDERGO CORONARY ARTERY BYPASS FOR TWO OR MORE DISEASED VESSELS AND AN AORTIC VALVE REPLACEMENT WITHIN 30 DAYS POST PROCEDURE. THIS SURGERY HAD NOT BEEN PERFORMED PRIOR TO THE DEATH. THE PATIENT'S CARDIAC SURGEON WAS WAITING UNTIL THE PATIENT WAS ABLE TO DISCONTINUE THE PLAVIX BEFORE HIS SURGERY WAS SCHEDULED. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL INFORMATION AVAILABLE. CHOICE STUDY EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR GALWAY NA 391012

    Patients

    Seq Age Sex Outcome Treatment
    1 Death BIVALIRUDIN| EMBOSHIELD