BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1944831 · Received January 3, 2011

    Report

    Report Number
    3004742046-2011-00003
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    AV-TEMECULA-VS
    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. INCORRECT REMOVAL. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. BASED ON THE REPORTED INFORMATION, IT APPEARS THAT THE LOCATION OF THE NEWLY PLACED XACT STENT (THE ANGULAR SECTION DISTAL TO THE NEWLY DEPLOYED STENT) CONTRIBUTED TO THE REPORTED DIFFICULTY ADVANCING THE RETRIEVAL CATHETER AND RESISTANCE WITH XACT STENT. THE FILTER WAS EVENTUALLY RETRIEVED AFTER SEVERAL PATIENT MANEUVERS WERE USED SUCH AS TURNING THE HEAD, COUGHING, AND USING A SLIGHT BEND ON THE RETRIEVAL CATHETER. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. ADDITIONALLY, THE LOT RELEASE TESTING RESULTS WERE REVIEWED AND ALL SAMPLES MET ALL MANUFACTURING CRITERIA. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CASE CIRCUMSTANCES AND 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 DURING AN INTERVENTIONAL PROCEDURE OF THE LEFT INTERNAL CAROTID ARTERY, THE EMBOSHIELD NAV6 FILTRATION ELEMENT (FE) WAS PLACED, THE LESION PREDILATED AND AN XACT STENT WAS DEPLOYED. IT WAS DIFFICULT TO RETRIEVE THE FE WITH THE RETRIEVAL CATHETER DUE TO THE ANGULAR SECTION DISTAL TO THE NEWLY DEPLOYED STENT. SEVERAL PATIENT MANEUVERS WERE ATTEMPTED SUCH AS TURNING THE HEAD, COUGHING, AND USING A SLIGHT BEND ON THE CATHETER. THE PHYSICIAN EVENTUALLY PULLED THE FILTER ELEMENT THROUGH THE STENT WHILE IN AN OPEN/UNRETRIEVED CONDITION. THERE WAS NO REPORTED RESULTANT PATIENT EFFECT. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT SUBMITTED ADDITIONAL INFORMATION WAS RECEIVED WHICH STATED THE EMBOSHIELD NAV6 FILTRATION ELEMENT WAS ABLE TO BE CAPTURED AND RETRIEVED; ALTHOUGH THERE WAS DIFFICULTY ADVANCING THE RETRIEVAL CATHETER (RC), THE FILTER WAS SUCCESSFULLY REMOVED INSIDE THE RC. THERE WAS NO REPORTED RESULTANT PATIENT EFFECT. THE PATIENT WAS DISCHARGED TO HOME (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM EMBOLIC PROTECTION SYSTEM NTE AV-TEMECULA-VS 0102251

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention HEPARIN| XACT STENT