BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2260775 · Received September 22, 2011

    Report

    Report Number
    2024168-2011-06514
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: THE EMBOLIC PROTECTION SYSTEM (EPS) WAS RETURNED WITH BLOOD IN THE FILTRATION ELEMENT AND ON THE COILS AND CORE AND NO SALINE VISIBLE. THE FILTRATION ELEMENT WAS DEPLOYED ON THE BAREWIRE. THERE WAS NO DAMAGE NOTED TO THE FILTRATION ELEMENT. ONLY THE BAREWIRE AND FILTRATION ELEMENT WERE RETURNED. THERE WERE TWO BENDS IN THE CORE 128 CM AND 137 CM DISTAL TO THE PROXIMAL END OF THE BAREWIRE, LIKELY DUE TO THE REPORTED ENTANGLEMENT. A LASER MICROMETER WAS USED TO MEASURE THE OUTER DIAMETER OF THE BAREWIRE. THE OUTER DIAMETER MET MANUFACTURING CRITERIA. THE TIP WAS TUGGED ON TO CONFIRM THAT THE CORE WAS INTACT. BASED ON THE REPORTED INFORMATION, IT APPEARS THAT THE ENTANGLEMENT AND DIFFICULTY REMOVING THE FILTER IS DUE TO INTERACTION WITH THE ATHERECTOMY DEVICE. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE WAS BEING USED IN THE SUPERFICIAL FEMORAL ARTERY. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE 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 COULD NOT BE DETERMINED IF THE OFF-LABEL USE CONTRIBUTED TO THE DIFFICULTIES. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT REVEALED NO ASSOCIATED NONCONFORMING MATERIAL RECORDS, INDICATING ALL LOT RELEASE TESTING MET SPECIFICATION. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT WAS PERFORMED AND REVEALED NO OTHER INCIDENTS FOR ENTANGLEMENT REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. AS PART OF THE MANUFACTURING QUALITY PROCESS, ALL EMBOLIC PROTECTION DEVICES ARE 100% 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 THE DEVICE WAS BEING USED IN THE SUPERFICIAL FEMORAL ARTERY. ATHERECTOMY WITH A NON-ABBOTT DEVICE WAS BEING PERFORMED WHEN THE BARE WIRE BECAME TRAPPED IN THE ATHERECTOMY DEVICE. ATTEMPTS TO REMOVE THE DEVICE WERE UNSUCCESSFUL AND THE DEVICES WERE REMOVED TOGETHER FROM THE PATIENT SUCCESSFULLY, LEAVING NOTHING IN THE PATIENT. THE FILTER COULD NOT BE RESHEATHED AND WAS REMOVED FROM THE PATIENT IN AN OPEN CONDITION; HOWEVER, NO PATIENT EFFECTS WERE REPORTED. 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 0032351

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR