BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 7820112 · Received August 27, 2018

    Report

    Report Number
    2024168-2018-06627
    Event Type
    Injury
    Date Received
    August 27, 2018
    Date of Event
    August 2, 2018
    Report Date
    September 7, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE OTHER EMBOSHIELD NAV6 DEVICE IS FILED UNDER SEPARATE MANUFACTURING REPORT NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT REVEALED NO SIMILAR INCIDENTS. IT SHOULD BE NOTED THAT THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM IS INDICATED FOR USE AS A GUIDE WIRE AND EMBOLIC PROTECTION SYSTEM TO CONTAIN AND REMOVE EMBOLIC MATERIAL (THROMBUS/DEBRIS) WHILE PERFORMING ANGIOPLASTY AND STENTING PROCEDURES IN CAROTID ARTERIES. THE INVESTIGATION WAS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED DIFFICULTIES. 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 · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH RESTENOSIS IN UNSPECIFIED STENTS AND BLOOD CLOTS WITHIN THE POPLITEAL TO THE ANTERIOR TIBIAL ARTERIES. THE FIRST EMBOSHIELD NAV 6 ADVANCED AND WAS USED IN THE POPLITEAL TO THE ANTERIOR TIBIAL ARTERIES. FOLLOWING, THE DEVICE COULD NOT BE RETRIEVED WITH THE RETRIEVAL CATHETER. DURING RETRIEVAL ATTEMPTS, THE EMBOSHIELD NAV 6 KEPT MIGRATING DISTALLY AND WAS NOT APPOSED THE VESSEL WALL. A NON-ABBOTT RETRIEVAL DEVICE WAS USED TO RETRIEVE THIS EMBOSHIELD NAV 6. A SECOND EMBOSHIELD NAV 6 WAS USED IN THE SAME AREA AS THE FIRST ONE AND THEN COULD NOT BE RETRIEVED WITH THE PROVIDED RETRIEVAL CATHETER. DURING RETRIEVAL ATTEMPTS, THE EMBOSHIELD NAV 6 KEPT MIGRATING DISTALLY AND WAS NOT APPOSED TO THE VESSEL WALL. AN NON-ABBOTT RETRIEVAL DEVICE WAS USED TO RETRIEVE THIS SECOND EMBOSHIELD NAV 6. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657486 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 8051561

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 315 BAREWIRE