BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1756255 · Received July 9, 2010

    Report

    Report Number
    3004742046-2010-00301
    Event Type
    Malfunction
    Date Received
    July 9, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 14, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RX ACCULINK (PART# 1011338-40, LOT# 0010551) INDICATED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    NAV 6 - DEVICE ISSUE: PROXIMAL MIGRATION OF THE FILTER. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT DURING A CAROTID ARTERY STENTING PROCEDURE, IN A MODERATELY TORTUOUS VESSEL, AFTER DEPLOYMENT OF THE NAV 6 EMBOSHIELD EMBOLIC PROTECTION DEVICE (EPD) AND DURING ADVANCEMENT OF THE RX ACCULINK STENT DELIVERY SYSTEM (SDS), THE EPD MAY HAVE MIGRATED SLIGHTLY PROXIMALLY. DURING STENT DEPLOYMENT, THE PROXIMAL TIP OF THE SDS "MARRIED" WITH THE EPD. THE STENT WAS DEPLOYED SUCCESSFULLY AND NO RESISTANCE WAS FELT WHEN REMOVING THE SDS. A SECOND, PLANNED STENT WAS IMPLANTED AND DURING POST-STENT DILATATION, THE TIP OF THE FIRST SDS WAS SEEN UNDER FLUOROSCOPY. THE SDS WAS THEN EXAMINED AND IT WAS NOTICED THAT THE TIP WAS MISSING. THE EPD WAS RECOVERED WITHOUT ISSUE, WITH THE DISTAL TIP OF THE SDS CAPTURED INSIDE. THERE WAS NO ADVERSE PT SEQUELA REPORTED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 0042651

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR STENT:RX ACCULINK (PART# 1011338-40, LOT# 0010551)