BEUDAMED
    FDA Adverse Event Death Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1725459 · Received June 11, 2010

    Report

    Report Number
    3004742046-2010-00250
    Event Type
    Death
    Date Received
    June 11, 2010
    Date of Event
    May 17, 2010
    Report Date
    May 17, 2010
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE STENT REMAINS IN THE PT'S BODY. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: CARDIOPULMONARY ARREST AND DEATH. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED VIA A TRIAL THAT AN XACT STENT WAS IMPLANTED IN THE LEFT INTERNAL CAROTID ARTERY ON (B) (6) 2010. THE PT HAD PNEUMONIA PRIOR TO THE PROCEDURE AND THROAT CANCER THAT WAS IN REMISSION UNTIL (B) (6) 2010, REQUIRING AN EMERGENT TRACHEOTOMY. A LEFT RADICAL NECK SURGERY WAS PLANNED AFTER THE PT'S CAROTID PROCEDURE AS BOTH CAROTIDS WERE BLOCKED. THE PT'S CONDITION WAS DETERIORATING AND THE PT'S STATUS WAS CHANGED TO DNR. FOUR DAYS AFTER THE CAROTID PROCEDURE, THE PT DEVELOPED CARDIOPULMONARY ARREST AND EXPIRED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 0031061

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death HEPARIN| EMBOLIC PROTECTION: EMBOLISHED NAV 6 (22438-19,| LOT # 0022251)