BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1914446 · Received December 3, 2010

    Report

    Report Number
    3004742046-2010-00573
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 DEVICE WAS NOT RETURNED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND MAY HAVE ASSISTED IN THE INVESTIGATION. ADDITIONAL INFORMATION WAS REQUESTED TO CONFIRM IF THE BAREWIRE PROVIDED WITH THE PACKAGING WAS USED; HOWEVER, NO INFORMATION HAS BEEN RECEIVED. IT SHOULD BE NOTED THAT THE PRODUCT INSTRUCTIONS FOR USE (IFU) STATES IN THE WARNING SECTION, 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. CEREBROVASCULAR ACCIDENT IS LISTED IN THE EMBOSHIELD NAV6 IFU AS KNOWN ADVERSE PATIENT EFFECTS. ALTHOUGH IT IS POSSIBLE THAT A NON BAREWIRE GUIDE WIRE WAS USED IN THE PROCEDURE, WHICH SUBSEQUENTLY CONTRIBUTED TO THE FILTER SEPARATION, THIS CANNOT BE CONCLUSIVELY DETERMINED. ATTEMPTS TO RETRIEVE THE FILTER WERE UNSUCCESSFUL AND THE DECISION WAS MADE TO LEAVE THE FILTER IN THE PATIENT AND TREATED WITH HEPARIN. THE FILTER REMAINING INSIDE OF THE PATIENT APPEARS TO HAVE CONTRIBUTED TO THE REPORTED CEREBROVASCULAR ACCIDENT. IN THIS CASE, THE EVENT APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. ALTHOUGH A CONCLUSIVE CAUSE CANNOT BE DETERMINED FOR THE SEPARATION OF THE FILTER, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4) - GUIDE WIRE SELECTION. ADDITIONAL INFORMATION WAS RECEIVED STATING THE TECHNICIAN HAD HANDED THE PHYSICIAN THE INCORRECT GUIDE WIRE WHICH WAS A BOSTON SCIENTIFIC .014 INCH GUIDE WIRE. THIS CONFIRMS THE INCORRECT WIRE WAS USED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE MEDWATCH FOLLOW-UP REPORT, ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN STATED THAT THE TECHNICIAN HAD HANDED HIM THE INCORRECT GUIDE WIRE. HE HAD USED A 0.014 INCH NON-ABBOTT GUIDE WIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT INTERNAL CAROTID STENTING PROCEDURE, IN A HEAVILY TORTUOUS AND CALCIFIED VESSEL, DURING RETRIEVAL OF THE NAV6 EMBOLIC PROTECTION DEVICE (EPD), THE PHYSICIAN THOUGHT THE EPD WAS SUCCESSFULLY CAPTURED IN THE RETRIEVAL CATHETER. WHEN THE DEVICES WERE REMOVED FROM THE ANATOMY, IT WAS NOTED THAT ONLY THE INTACT WIRE AND RETRIEVAL CATHETER WERE REMOVED. ANGIOGRAPHY SHOWED THE BASKET REMAINED WELL DISTAL TO THE NEWLY PLACED XACT STENT. UNSUCCESSFUL ATTEMPTS WERE MADE TO SNARE THE BASKET AS WELL AS AN UNSUCCESSFUL ATTEMPT TO PLACE A BALLOON BEYOND THE FILTER TO PULL THE BASKET DOWN. TISSUE PLASMINOGEN ACTIVATOR (TPA) AND BLOOD PRODUCTS WERE ADMINISTERED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WHERE A NEUROSURGEON WAS CONSULTED. THE DECISION WAS MADE TO LEAVE THE BASKET IN THE PATIENT AND TO CONTINUE GIVING HEPARIN. DURING THE EVENING OF THE PROCEDURE, THE PATIENT EXPERIENCED A STROKE. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT WAS UNABLE TO CROSS THE LESION. THE LESION WAS LOCATED IN A HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.25X16MM TAXUS LIBERTE' ATOM STENT WAS ADVANCED TO THE LESION, BUT COULD NOT CROSS. THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS LIBERTE' ATOM STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS STABLE. PRODUCT ANALYSIS REVEALED THAT THE STENT HAD DISLODGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA 0081951

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R| S 0.014" BOSTON SCIENTIFIC GUIDE WIRE