BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2143454 · Received June 29, 2011

    Report

    Report Number
    2024168-2011-04551
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 7, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 EMBOLIC PROTECTION SYSTEM (EPS) WAS RETURNED WITH THICK BLOOD ON THE BAREWIRE, CONSISTENT WITH THE REPORTED USE. THE FILTRATION ELEMENT WAS NOT RETURNED LOADED INTO THE RECOVERY CATHETER. THE TIP OF THE BAREWIRE WAS BENT IN A J SHAPE, CONSISTENT WITH TIP SHAPING. THERE WAS NO OTHER DAMAGE NOTED TO THE EPS. A PIN GAUGE WAS USED TO MEASURE THE INNER DIAMETER OF THE RECOVERY CATHETER POD. THIS MET MANUFACTURING CRITERIA. THE CROSSING PROFILE WAS MEASURED WITH A LASER MICROMETER AND MET MANUFACTURING CRITERIA. DURING FUNCTIONAL TESTING, THE TIP OF THE BAREWIRE WAS TUGGED TO CONFIRM THAT THE CORE WAS INTACT. THE BAREWIRE WAS BACKLOADED INTO THE RECOVERY CATHETER AND THERE WAS NO RESISTANCE NOTED. DIFFICULTY ADVANCING THE RECOVERY CATHETER MAY INCLUDE, BUT 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. TO ENSURE THIS TYPE OF ISSUE IS NOT MANUFACTURING RELATED, AS PART OF THE MANUFACTURING QUALITY PROCESS, ALL EMBOLIC PROTECTION DEVICES AND RETRIEVAL CATHETERS ARE 100% VISUALLY INSPECTED FOR DAMAGE. IN ADDITION, A SAMPLING OF UNITS IS VISUALLY, DIMENSIONALLY AND FUNCTIONALLY INSPECTED. IN THIS CASE, BASED ON THE REPORTED INFORMATION, THE DIFFICULTY ADVANCING THE RECOVERY CATHETER APPEARS TO BE RELATED TO INTERACTION WITH THE RECOVERY CATHETER AND PROXIMAL STENOSIS AND/OR THE PROXIMAL END OF THE NEWLY PACED XACT STENT. AFTER THE FAILED ATTEMPT TO ADVANCE, THE RECOVERY CATHETER WAS REMOVED AND THE PROXIMAL LESION WAS STENTED. THE NAV6 FILTER WAS THEN RECOVERED WITHOUT ISSUE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD (LHR) DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS (NCMR) FOR THIS LOT AND THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT DEFICIENCY. A QUERY OF THE COMPLAINT DATABASE WAS PERFORMED AND THERE IS NO INDICATION TO SUGGEST A LOT SPECIFIC PRODUCT DEFICIENCY. OVERALL, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CASE CIRCUMSTANCES AND THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE NAV6 FILTER AND THE XACT STENT WERE PLACED SUCCESSFULLY OVER THE DISTAL SEGMENT OF A LONG LESION. PROXIMAL TO THE STENT WAS SOME MILD DISEASE WHICH WAS NOT PLANNED TO BE STENTED. THE FILTER RECOVERY CATHETER WAS ADVANCED, BUT WOULD NOT CROSS THE PROXIMAL STENOSIS. THE RECOVERY CATHETER WAS REMOVED AND THE PROXIMAL LESION WAS STENTED. THE NAV6 FILTER WAS THEN RECOVERED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT SEQUELA. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED TO HOME. 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-CT 1031651

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention STENT: XACT STENTS: 9-7X40, 7X20