BEUDAMED
    FDA Adverse Event Death Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1709317 · Received June 2, 2010

    Report

    Report Number
    3004742046-2010-00237
    Event Type
    Death
    Date Received
    June 2, 2010
    Date of Event
    May 7, 2010
    Report Date
    May 7, 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
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE DEVICE WAS NOT RETURNED. THE LOT NUMBER WAS NOT PROVIDED. A F/U REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: DEATH. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED THAT THE PT UNDERWENT AN UNEVENTFUL STENTING PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY WITH THE XACT STENT. THE PT'S ACT WAS THERAPEUTIC DURING THE PROCEDURE AND THE EMBOSHIELD NA V6 WAS IN THE PT FOR LESS THAN 7 MINUTES. AFTER THE PROCEDURE, THE PT EXPERIENCED HYPOTENSION THAT WAS TREATED WITH DOPAMINE INFUSION. THE FOLLOWING DAY, THE PT DEVELOPED VENTRICULAR TACHYCARDIA THEN ASYSTOLE. ATTEMPTS TO RESUSCITATE THE PT WERE MADE FOR APPROXIMATELY THIRTY TO FORTY MINUTES BEFORE LIFE-SAVING MEASURES WERE WITHDRAWN. THE CAUSE OF THE PT'S DEATH WAS CARDIAC ARRHYTHMIA AND CARDIAC ARREST. THE PT HAD A HISTORY OF SEVERE AORTIC STENOSIS THAT WAS PLANNED TO BE TREATED WITH OPEN AORTIC VALVE REPLACEMENT AFTER HIS RECOVERY FROM THE CAROTID STENTING PROCEDURE. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death VESSEL CLOSURE: STARCLOSE| EMBOLIC PROTECTION: EMBOSHIELD NA V6