BEUDAMED
    FDA Adverse Event Death Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 968231 · Received December 19, 2007

    Report

    Report Number
    3004742046-2007-00393
    Event Type
    Death
    Date Received
    December 19, 2007
    Date of Event
    November 18, 2007
    Report Date
    November 28, 2007
    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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE STENT REMAINS IN THE PT. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THE RX ACCULINK PART #1011342-20 & LOT #6102051 REFERENCED IS BEING FILED UNDER THIS MEDWATCH REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: DEATH. TIME OF SYMPTOMS/AE: AFTER THE PROCEDURE. IT WAS REPORTED THAT 27 DAYS POST AN UNEVENTFUL LEFT INTERNAL CAROTID ARTERY ANGIOPLASTY STENTING PROCEDURE, THE PT EXPIRED. THE PT COMPLAINED OF "COLD LIKE" SYMPTOMS AND WENT TO LIE DOWN. THE PT'S SPOUSE WENT TO CHECK ON HIM LATER, AND HE HAD EXPIRED. THE INITIAL EXAMINER REPORTED THAT THE DEATH MAY BE DUE TO A MYOCARDIAL INFARCTION, ALTHOUGH, PER THE PT'S FAMILY, NO AUTOPSY REPORT WILL BE PERFORMED. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL 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 7062551

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death BIVALIRUDIN| RX ACCULINK| RX ACCUNET