BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2830641 · Received November 13, 2012

    Report

    Report Number
    2024168-2012-07156
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT WAS REPORTED THE NAV6 DEVICE WAS USED IN THE POPLITEAL ARTERY. IT SHOULD BE NOTED THE INDICATIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU) 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. IT SHOULD ALSO BE NOTED THAT THE IFU STATES: DO NOT CONTINUE TO RETRACT THE BAREWIRE FILTER DELIVERY WIRE AGAINST SIGNIFICANT RESISTANCE. IF SIGNIFICANT RESISTANCE IS FELT, RETRACT THE GUIDE CATHETER OR SHEATH AND THE RX RETRIEVAL CATHETER TOGETHER. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS WAS AN ATHERECTOMY PROCEDURE WAS TO TREAT A LESION IN THE POPLITEAL ARTERY. AFTER ATHERECTOMY WAS PERFORMED SUCCESSFULLY, AN ATTEMPT WAS MADE TO REMOVE THE DEVICE, BUT IT BECAME STUCK ON THE EMBOSHIELD NAV6 WIRE. FORCE WAS USED TO REMOVE THE DEVICE, AND THE NAV6 WIRE SEPARATED. A SNARE DEVICE WAS USED TO REMOVE THE GUIDE WIRE; HOWEVER, THE FILTER COULD NOT GET THROUGH THE SHEATH, AND WENT TO THE PROFUNDA. THE FILTER WAS NOT REMOVED; HOWEVER, GOOD FLOW WAS CONFIRMED IN THE PROFUNDA, AND THE PATIENT HAD A GOOD FINAL OUTCOME. IT WAS NOTED THAT THERE WAS NO RESISTANCE WITH THE WIRE DURING ADVANCEMENT OF THE ATHERECTOMY DEVICE. 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 2071661

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention