BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 13619980 · Received February 28, 2022

    Report

    Report Number
    2024168-2022-02054
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    February 8, 2022
    Report Date
    April 15, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NTE
    UDI-DI
    08717648137754
    PMA / PMN Number
    K141678
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE XACT DEVICE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED EMBOSHIELD NAV6 EPS, AND THE REPORTED DIFFICULTY TO ADVANCE AND REMOVE WERE CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTY TO ADVANCE AND REMOVE APPEAR TO BE RELATED TO CASE CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE REPORTED INFORMATION, THERE WAS NO PRE-DILATION OF THE HEAVILY CALCIFIED VESSEL. IT IS LIKELY THAT DIFFICULTY TO ADVANCE WAS DUE TO THE HEAVY CALCIFICATION. MANIPULATION AGAINST RESISTANCE LIKELY CAUSE DAMAGE TO THE INNER LUMEN OF THE XACT DEVICE AND BAREWIRE FREEZING IN PLACE RESULTING IN THE DIFFICULTY TO REMOVE. THE NOTED BENDS AND COIL DAMAGE ON THE BAREWIRE LIKELY OCCURRED POST PROCEDURE OR DURING PACKING FOR RETURN ANALYSIS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED VESSEL IN THE LEFT CAROTID ARTERY. THE EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS) WAS USED AND THE BAREWIRE WAS SWITCHED TO THE 315MM. THE FILTER WAS DEPLOYED. NO PRE-DILATATION WAS PERFORMED. THE XACT CAROTID STENT SYSTEM WAS ATTEMPTED TO BE ADVANCED ON THE BAREWIRE BUT THERE WAS RESISTANCE AND IT ONLY MADE IT INTO THE SHEATH. IT WAS ATTEMPTED TO REMOVE THE DELIVERY SYSTEM BUT IT COULD NOT BE REMOVED EVEN WITH PUSH AND PULL ACTION. ULTIMATELY THERE WAS NO WAY TO RETRIEVE THE FILTER, SO THE FILTER WAS REMOVED OPEN AND TOGETHER WITH THE XACT STENT, THAT WAS NOT DEPLOYED, AND WAS PULLED AS ONE UNIT. ANOTHER EPS, XACT STENT AND BAREWIRE WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS A DELAY IN THE PROCEDURE AS ALL THE DEVICES HAD TO BE TAKEN FROM A DIFFERENT DEPARTMENT BUT THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882116 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR 22438-19 1093061 08717648137754

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male XACT CAROTID STENT SYSTEM