BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2024357 · Received March 18, 2011

    Report

    Report Number
    2024168-2011-01852
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE RX ACCULINK AND EMBOSHIELD NAV6 ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EMBOSHIELD NAV6 INSTRUCTIONS FOR USE STATES: REMOVE THE DELIVERY CATHETER WHILE MAINTAINING THE BAREWIRE FILTER DELIVERY WIRE POSITION. REPORTEDLY, THE PHYSICIAN REMOVED THE BAREWIRE FILTER DELIVERY WIRE AT THE SAME TIME AS THE DELIVERY CATHETER. DUE TO THE STEPPED NATURE OF THE BAREWIRE GUIDE WIRE TO ACT AS A DISTAL STOP FOR THE FILTER, REMOVAL OF THE BAREWIRE WOULD INEVITABLY CAUSE THE FILTER TO ALSO BE REMOVED FROM THE PATIENT. THE REPORTED EVENT IS DUE TO A USE ERROR. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD REVEALED NO NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR MIGRATION OF DEVICE COMPONENTS FOR THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE IN THE SCARRED INTERNAL CAROTID ARTERY, AFTER DEPLOYING THE EMBOSHIELD NAV6 FILTER AND UPON RETRACTING THE DELIVERY CATHETER AND BAREWIRE GUIDE WIRE TOGETHER FROM THE ANATOMY, THE OPEN FILTER WAS FOUND ON THE DELIVERY SYSTEM. ANOTHER NAV6 FILTER WAS DEPLOYED AND PREDILATATION WAS PERFORMED WITH THE VOYAGER BALLOON. THE RX ACCULINK STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TOWARDS THE LESION, BUT COULD NOT BE POSITIONED CORRECTLY AS THE DISTAL PART OF THE SDS AND PROXIMAL PART OF THE FILTER BECAME ENTANGLED. THERE WAS NO ATTEMPT TO UNTANGLE THE TWO DEVICES AND THEY WERE REMOVED AS ONE UNIT THROUGH THE SHEATH. THE BAREWIRE GUIDE WIRE REMAINED IN PLACE AND THE PROCEDURE WAS CONTINUED WITH NO EMBOLIC PROTECTION DEVICE. AS THE RX ACCULINK STENT WAS REINSERTED AND ADVANCED, IT WOULD NOT CROSS THE LESION AND THE 90 CM SHEATH SLIPPED PROXIMAL OF THE INTENDED POSITION. WHEN THE SHEATH WAS BROUGHT INTO THE CORRECT POSITION, THE PATIENT EXPERIENCED SYNCOPE. THE PROCEDURE WAS STOPPED AND ALL DEVICES WERE REMOVED FROM THE ANATOMY. THE PATIENT WAS TREATED WITH OXYGEN AND INFUSION. IT WAS CONFIRMED THAT THE PATIENT DID NOT HAVE A STROKE. FURTHER TREATMENT OF THE LESION WILL BE ADDRESSED AT A LATER DATE. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-CT 0110251

    Patients

    Seq Age Sex Outcome Treatment
    1