BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2153749 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04823
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE EMBOLIC PROTECTION SYSTEM (EPS) WAS RETURNED WITH BLOOD ON THE FILTRATION ELEMENT, RETRIEVAL CATHETER AND TORQUE DEVICE, CONSISTENT WITH THE REPORTED USE. THERE WAS NO SALINE VISIBLE. THE FILTRATION ELEMENT WAS FULLY DEPLOYED ON A NON-ABBOTT GUIDE WIRE. THE FILTRATION ELEMENT WIRE BROKE AT THE PROXIMAL MARKER BAND CONSISTENT WITH THE REPORTED INFORMATION. THERE WAS NO OTHER DAMAGE NOTED TO THE FILTRATION ELEMENT. THERE WAS NO OTHER DAMAGE NOTED TO THE EPS. THE NON-ABBOTT GUIDE WIRE WAS RETURNED WITH BLOOD ON THE CORE AND NO SALINE VISIBLE. THERE WAS NO DAMAGE NOTED TO THE GUIDE WIRE. PIN GAUGES WERE USED TO MEASURE THE INNER DIAMETER OF THE RETRIEVAL CATHETER, WHICH MET THE MANUFACTURING CRITERIA. DIFFICULTY RETRIEVING THE FILTRATION ELEMENT MAY INCLUDE, BUT IS NOT LIMITED TO, PATIENT ANATOMICAL CONDITIONS, STENT POST DILATATION STRATEGY, THE NEWLY DEPLOYED STENT NOT BEING FULLY APPOSED TO THE VESSEL WALL, LACK OF GUIDE CATHETER SUPPORT, INTERACTION BETWEEN ASSOCIATED DEVICES, DAMAGE TO THE RETRIEVAL CATHETER OR DAMAGE TO THE FILTRATION ELEMENT. IN THIS CASE, IT MAY BE POSSIBLE THAT ANATOMICAL CONDITIONS AND/OR USE OF THE EMBOSHIELD NAV 6 IN THE POPLITEAL ARTERY CAUSED OR CONTRIBUTED TO THE DIFFICULTY RETRIEVING. IT SHOULD BE NOTED THAT THE EMBOSHIELD NAV 6 INSTRUCTION FOR USE 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 DIAMETER OF THE ARTERY AT THE SITE OF THE FILTRATION ELEMENT PLACEMENT SHOULD BE BETWEEN 2.5 AND 7.0 MM. IN THIS CASE, IT COULD NOT BE DETERMINED IF THE USE OF THE EMBOSHIELD NAV 6 IN THE POPLITEAL ARTERY CAUSED OR CONTRIBUTED TO THE DIFFICULTY. IT IS ALSO LIKELY THAT DURING THE ATTEMPTS TO PULL THE FILTER ASSEMBLY INTO THE RETRIEVAL CATHETER AGAINST FORCE CAUSED THE DAMAGE TO THE FILTRATION ELEMENT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT AND A QUERY OF THE DATABASE FOUND THERE HAVE BEEN NO OTHER INCIDENTS FOR DIFFICULT TO REMOVE OR BREAK REPORTED FOR THIS LOT. THE REPORTED DIFFICULTIES AND SUBSEQUENT DAMAGE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DIFFICULTY REMOVING THE EMBOSHIELD NAV 6 EMBOLIC PROTECTION DEVICE (EPD) FROM THE POPLITEAL ARTERY. ON ANGIOGRAPHY THE RADIOPAQUE MARKERS DID NOT HAVE THE CORRECT SHAPE AND APPEARED TO BE STRETCHED OUT. THE EPD COULD ONLY BE PARTIALLY, HALF WAY ENCAPSULATED INTO RECOVERY CATHETER. THE GUIDE WIRE, RECOVERY CATHETER AND EPD WERE COMPLETELY REMOVED AS A SINGLE UNIT. AFTER REMOVAL, THE EPD WAS EXAMINED AND ONE RADIOPAQUE MARKER BAND WAS BROKEN AND WAS HANGING FROM THE PROXIMAL END. THERE WAS NO DEVICE SEPARATION. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT OR REMOVAL. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE OR THERAPY. 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 1042051

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR