BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6

    MDR report key: 21920901 · Received April 28, 2025

    Report

    Report Number
    2024168-2025-04381
    Event Type
    Injury
    Date Received
    April 28, 2025
    Date of Event
    January 29, 2024
    Report Date
    May 13, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NTE
    PMA / PMN Number
    K191173
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. LITERATURE ATTACHMENT: ARTICLE TITLE, "FABRICATION OF A MONORAIL TYPE DIAGNOSTIC CATHETER FOR RESCUE RETRIEVAL TECHNIQUE OF A DISTAL EMBOLIC PROTECTION DEVICE". B3: DATE OF EVENT ESTIMATED AS 01/29/2024. D4: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE PRODUCTION RECORDS FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE PART NUMBER AND/OR LOT NUMBER WAS NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. IN THIS CASE, IT IS LIKELY THAT INTERACTION WITH THE PREVIOUSLY PLACED STENT CONTRIBUTED TO THE DIFFICULTY CROSSING RETRIEVAL CATHETER PREVENTING THE ABILITY TO RETRIEVE THE FILTER. IT MAY BE POSSIBLE THAT THE STENT WAS NOT FULLY APPOSED TO THE VESSEL WALL OR WAS IMPLANTED AT A TORTUOUS LOCATION OF THE VESSEL. AS A RESULT, UNEXPECTED MEDICAL INTERVENTION WAS REQUIRED BY USING AN ALTERNATIVE DEVICE TO OVERCOME THE SHARP ANGLE TO RETRIEVE THE FILTER. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION, 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 THE 70% STENOSED LEFT PROXIMAL INTERNAL CAROTID ARTERY (ICA). THE LESION WAS ACCESSED AND A LARGE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED TO THE INTENDED LOCATION AND SUCCESSFULLY DEPLOYED. A NON-ABBOTT BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND INFLATED TO 10 ATMOSPHERES. A 7X40 MM ACCULINK CAROTID SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED AND DEPLOYED IN THE PROXIMAL ICA. FOLLOWING STENT DEPLOYMENT, A SPATIAL SEPARATION WAS OBSERVED BETWEEN THE PROXIMAL END OF THE STENT AND THE ARTERIAL WALL, ATTRIBUTED TO THE ICA'S INHERENT CURVATURE. UPON ATTEMPTED RETRIEVAL OF THE EMBOSHIELD NAV6 FILTER, THE RETRIEVAL CATHETER'S PROGRESSION WAS HINDERED AT THE PROXIMAL END OF THE STENT, ENTRAPPED BY THE PROTRUDING STRUT. THE RETRIEVAL CATHETER COULD NOT BE ADVANCED SO THE NEED FOR AN ALTERNATIVE DEVICE TO OVERCOME THE SHARP ANGLE WAS ADDRESSED BY MANIPULATING ANOTHER DEVICE AND ADVANCING IT TO THE FILTER. THE CATHETER WAS ABLE TO NAVIGATE TO THE FILTER AND THE FILTER WAS RETRIEVED. THE PATIENT EXPERIENCED NO THROMBOEMBOLIC EVENTS AND THERE WERE NO NEW NEUROLOGIC DEFICITS. THE PATIENT WAS DISCHARGED 2 DAYS LATER. ADDITIONAL INFORMATION CAN BE FOUND IN THE ARTICLE "FABRICATION OF A MONORAIL-TYPE DIAGNOSTIC CATHETER FOR RESCUE RETRIEVAL TECHNIQUE OF A DISTAL EMBOLIC PROTECTION DEVICE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1708295 EMBOSHIELD NAV6 TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE ABBOTT VASCULAR INC. UNK EMBOSHIELD NAV6

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Unknown Required Intervention| H ACCULINK STENT