BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 17144298 · Received June 16, 2023

    Report

    Report Number
    2024168-2023-06372
    Event Type
    Injury
    Date Received
    June 16, 2023
    Date of Event
    May 23, 2023
    Report Date
    June 16, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIM
    UDI-DI
    08717648010279
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECT OF VESSEL THROMBOSIS IS LISTED IN THE XACT CAROTID STENT SYSTEM INFORMATION FOR PRESCRIBERS AS AN ADVERSE EVENT POTENTIALLY ASSOCIATED WITH CAROTID STENTS AND EMBOLIC PROTECTION SYSTEMS. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE RIGHT INTERNAL CAROTID ARTERY DUE TO VISION LOSS THAT THE PATIENT WAS EXPERIENCING ON THE LEFT SIDE, INDICATING AN ISSUE IN THE RIGHT ARTERY WITH 99% STENOSIS, NONE CALCIFICATION AND NONE TORTUOSITY. AN EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED AND THE FIRST XACT STENT (LOT 2121461) WAS IMPLANTED BY DIRECT STENTING IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) WITHOUT ISSUE. THE EMBOSHIELD NAV6 WAS REMOVED. AT THIS TIME IT WAS NOTED THAT THE PATIENT HAD LOST MOVEMENT IN THE FOOT AND LEG ON THE RIGHT SIDE AS WELL AS A LOSS OF SPEECH. A CLOT HAD FORMED IN THE LEFT ICA/EXTERNAL CAROTID ARTERY. AN EMBOSHIELD NAV6 (LOT 3031661) WAS ATTEMPTED TO BE ADVANCED BUT COULD NOT PASS SO BALLOON DILATATION WAS PERFORMED WITH A VIATRAC BALLOON AND THEN THE EMBOSHIELD NAV6 WAS ABLE TO BE ADVANCED TO THE DESIRED LOCATION. THEN AN XACT STENT WAS PLACED IN THE LEFT ICA AND POST DILATED WITH THE VIATRAC BALLOON. FOUR MG OF TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED. FLOW TO THE BRAIN WAS RESTORED. THE STENTS ARE PATENT. THERE WAS NO DIAGNOSIS OF STROKE OR TRANSIENT ISCHEMIC ATTACK. THE PATIENT REMAINED HOSPITALIZED IN THE INTENSIVE CARE UNIT AND THREE DAYS LATER IT WAS REPORTED THAT THE PATIENT HAD IMPROVED WITH NORMAL SPEECH, REGAINED RIGHT SIDE MOVEMENT AND ABLE TO FOLLOW COMMANDS. THE PATIENT WILL BE SENT TO REHABILITATION FOR RECOVERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014526 XACT CAROTID STENT SYSTEM SELF EXPANDING PERIPHERAL STENT SYSTEM NIM ABBOTT VASCULAR 82091-01 2121461 08717648010279

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention| H VIATRAC BALLOON