BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1980162 · Received February 7, 2011

    Report

    Report Number
    2024168-2011-00721
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. DIFFICULTY RETRIEVING THE FILTRATION ELEMENT MAY INCLUDE, BUT IS NOT LIMITED TO, PATIENT ANATOMICAL CONDITIONS, STENT POST DILATATION STRATEGY, AND THE NEWLY DEPLOYED STENT NOT BEING FULLY APPOSED TO THE VESSEL WALL, LACK OF GUIDE CATHETER SUPPORT OR INTERACTION BETWEEN ASSOCIATED DEVICES. THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS AND MAY HAVE ASSISTED IN THE INVESTIGATION. IN THIS CASE, AN RX ACCUNET RECOVERY CATHETER WAS USED TO SUCCESSFULLY RETRIEVE THE FILTER (ADDITIONAL THERAPY/ NON-SURGICAL PROCEDURE). AS REPORTED, IT APPEARS THAT THE PATIENT ANATOMICAL CONDITIONS CONTRIBUTED TO THE DIFFICULTY REMOVING THE FILTER. IN THIS CASE, WITHOUT HAVING THE PRODUCT FOR INVESTIGATION, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY RETRIEVING THE FILTRATION ELEMENT COULD NOT BE DETERMINED. HOWEVER, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT DURING A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, DUE TO PATIENT ANATOMY, DIFFICULTY WAS ENCOUNTERED WHILE ATTEMPTING TO REMOVE THE NAV6 FILTER ELEMENT. AN RX ACCUNET RECOVERY CATHETER SUCCESSFULLY REMOVED THE DEVICE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. 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 0101551

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention STENT: RX ACCULINK,HEPARIN