BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2032844 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02121
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. DILATATION CATHETER: 6.0 X 20 MM VIATRAC; STENT: 8-6 X 40 MM XACT. EVALUATION SUMMARY: EVALUATION OF THE RETURNED EMBOSHIELD EMBOLIC PROTECTION DEVICE (EPD) NOTED BLOOD ON THE DISTAL SHAFT AND ON THE TIP, CONSISTENT WITH THE REPORTED USE. THERE WAS NO DAMAGE NOTED TO THE RETRIEVAL CATHETER. ONLY THE RETRIEVAL CATHETER WAS RETURNED. THE INNER DIAMETER OF THE RETRIEVAL CATHETER TIP WAS MEASURED AND THIS MET MANUFACTURING CRITERIA. DIFFICULTY RETRIEVING THE FILTRATION ELEMENT THROUGH THE STENT 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 OR INTERACTION BETWEEN ASSOCIATED DEVICES. IT MAY BE POSSIBLE THAT THE DIFFICULTY ADVANCING THE RECOVERY CATHETER IS DUE TO INTERACTION WITH NEWLY PLACED STENT; HOWEVER, THIS COULD NOT BE CONFIRMED. AS A RESULT OF THE DIFFICULTY, A SECOND RETRIEVAL CATHETER WAS USED TO SUCCESSFULLY CAPTURE THE EPD. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT AND THERE HAVE BEEN NO OTHER INCIDENTS FOR DIFFICULT TO REMOVE OR RESISTANCE REPORTED FOR THIS LOT. ADDITIONALLY, THE LOT RELEASE TESTING RESULTS WERE REVIEWED AND ALL SAMPLES MET ALL MANUFACTURING CRITERIA. A QUERY OF THE COMPLAINT DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY COULD NOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. AS PART OF THE MANUFACTURING QUALITY PROCESS, ALL EMBOLIC PROTECTION DEVICES ARE VISUALLY INSPECTED FOR DAMAGE. IN ADDITION, A SAMPLING OF UNITS IS VISUALLY, DIMENSIONALLY AND FUNCTIONALLY INSPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-STENTING DURING A CAROTID ARTERY PROCEDURE THE EMBOSHIELD NAV6 EMBOLIC PROTECTION DEVICE (EPD) WAS ATTEMPTED TO BE RETRIEVED FROM THE ARTERY, BUT COULD NOT BE CAPTURED WITH THE RETRIEVAL CATHETER THREE SEPARATE TIMES. A SECOND RETRIEVAL CATHETER WAS USED TO SUCCESSFULLY CAPTURE THE EPD. THERE WAS NO ADVERSE PATIENT EFFECT. 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 0101851

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention