BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 2104116 · Received May 26, 2011

    Report

    Report Number
    2024168-2011-03741
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 DEVICE WAS NOT RETURNED. THE REPORTED MIGRATION APPEARS TO BE RELATED TO CASE CIRCUMSTANCES AND THERE IS NO INDICATION TO SUGGEST A PRODUCT DEFICIENCY. MIGRATION OF THE FILTER CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, DEVICE PLACEMENT TECHNIQUE, ACCESSORY DEVICE SUPPORT, AND INSUFFICIENT LANDING ZONE FOR THE FILTER BASKET. THE EMBOSHIELD NAV6 INSTRUCTION FOR USE PROVIDES THE FOLLOWING PRECAUTIONS: MAINTAIN PROPER GUIDING CATHETER/SHEATH SUPPORT IN THE COMMON CAROTID ARTERY THROUGHOUT THE PROCEDURE. ENSURE THAT THERE IS ADEQUATE DISTANCE BETWEEN THE PROXIMAL TIP OF THE FILTRATION ELEMENT AND THE MOST DISTAL TIP OF ANY INTERVENTIONAL DEVICE TO BE INTRODUCED OVER THE FILTER DELIVERY WIRE TO AVOID ENGAGEMENT. BASED ON THE CASE DESCRIPTION, THE FILTER MIGRATION APPEARS TO BE RELATED TO LOSS OF GUIDING CATHETER SUPPORT CAUSING THE FILTRATION ELEMENT TO MIGRATE DOWN. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. A QUERY OF THE COMPLAINT DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS FOR FILTER MIGRATION REPORTED FOR THIS LOT. ALL EMBOLIC PROTECTION DEVICES ARE 100% VISUALLY INSPECTED FOR DAMAGE AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT THE XACT STENT WAS UNABLE TO CROSS THE PRE-DILATED, TORTUOUS RIGHT COMMON CAROTID (RCC) ARTERY. DURING ATTEMPTS TO CROSS THE RCC, THE PHYSICIAN LOST CONTROL OF THE GUIDING CATHETER AND THE EMBOSHIELD NAV6 BARE WIRE MIGRATED DOWN TO THE BIFURCATION OF THE COMMON CAROTID ARTERY. ALL OF THE DEVICES WERE REMOVED AS A SINGLE UNIT AND VESSEL ACCESS WAS LOST. THE TARGET LESION IN THE RIGHT INTERNAL AND RCC WERE REACCESSED WITH A SECOND EMBOSHIELD NAV6 AND THE PROCEDURE WAS COMPLETED WITH THE IMPLANTATION OF THE XACT STENT. THE CAROTID STENTING PROCEDURE TOOK 1.5 HOURS, WHICH WAS LONGER THAN EXPECTED FOR THIS PATIENT. DURING THE PROCEDURE, THE PATIENT EXPERIENCED HYPERTENSION TWICE (216/100, 203/100) REQUIRING TWO DOSES OF HYDROCHLORATHIAZIDE (5 MG THEN 10 MG INTRAVENOUSLY.) AFTER THE PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION REQUIRING A DOPAMINE INFUSION FOR ONE DAY. THE HYPOTENSION RESOLVED UPON DISCHARGE THE FOLLOWING DAY. THE PATIENTS ORAL ANTI-HYPERTENSIVE MEDICATIONS WERE HELD FOR ONE DAY AFTER DISCHARGE. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 1012051

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention