BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1935542 · Received December 22, 2010

    Report

    Report Number
    3004742046-2010-00614
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    AV-TEMECULA-VS
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A THOROUGH ANALYSIS COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. REPORTEDLY, A NON-ABBOTT STABILIZER WIRE WAS USED DURING THE PROCEDURE. IT SHOULD BE NOTED THAT THE EMBOSHIELD NAV 6 INSTRUCTIONS FOR USE (IFU) STATES THAT THE EMBOSHIELD NAV6 DEVICE CAN ONLY BE USED WITH THE BAREWIRE FILTER DELIVERY WIRE. USE OF THE DEVICE WITH ANY GUIDE WIRE OTHER THAN THE BAREWIRE FILTER DELIVERY WIRE WILL LEAD TO LOSS OF THE FILTRATION ELEMENT DURING THE PROCEDURE OR AN INABILITY TO RETRIEVE THE FILTRATION ELEMENT. IT IS LIKELY THAT THE REPORTED DIFFICULTY OF REMOVING THE FILTRATION ELEMENT IS DUE TO THE WRONG GUIDE WIRE USED DURING THE PROCEDURE. REPORTEDLY, THE EMBOSHIELD NAV 6 WAS USED IN A CORONARY SAPHENOUS VEIN GRAFT. IT SHOULD BE NOTED THAT THE IFU STATES THAT THE DEVICE IS A TEMPORARY PERCUTANEOUS TRANSLUMINAL FILTRATION SYSTEM DESIGNED TO CAPTURE EMBOLIC MATERIAL RELEASED DURING ANGIOPLASTY AND STENT PROCEDURES WITHIN CAROTID ARTERIES. ALTHOUGH THE DEVICE IS NOT INDICATED FOR USE IN THE CORONARY ARTERIES, IT DOES NOT APPEAR THAT THE OFF LABEL USE IN THE INCORRECT ANATOMY CONTRIBUTED TO THE REPORTED COMPLAINT AS THE WRONG GUIDE WIRE USED DURING THE PROCEDURE LIKELY CAUSED THE REPORTED FILTER SEPARATION. THE REPORTED EVENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. INCORRECT ANATOMY AND GUIDE WIRE. THE STENT REMAINS IN THE PATIENT. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SAPHENOUS VEIN GRAFT TO OBTUSE MARGINAL 1 STENTING PROCEDURE, A EMBOSHIELD NAV6 FILTER WAS DEPLOYED ON A NON-ABBOTT STABILIZER WIRE. UPON RETRIEVAL OF THE FILTER, THE FILTER DETACHED AND WAS LEFT IN THE VESSEL. TWO BALLOON EXPANDABLE STENTS WERE DEPLOYED, EMBEDDING THE FILTER UP AGAINST THE WALL OF THE VESSEL. TIMI FLOW OF 3 WAS ACHIEVED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO SIGNIFICANT DELAY IN PROCEDURE REPORTED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-VS 0032351

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention