BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1903744 · Received November 20, 2010

    Report

    Report Number
    3004742046-2010-00543
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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. RX ACCULINK CAROTID STENT SYSTEM (PART #1011344-40, LOT #0062961). THE RX ACCULINK CAROTID STENT SYSTEM (PART #1011344-40, LOT #0062961) REPORTED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE ANALYSIS OF THE RETURNED PRODUCT DID NOT DEMONSTRATE ANY PRODUCT DEFICIENCY WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE WERE NO DAMAGES NOTED TO THE DELIVERY CATHETER, FILTRATION ELEMENT OR BAREWIRE GUIDE WIRE. BASED ON AVAILABLE INFORMATION, A CONCLUSIVE CAUSE APPEARS TO BE RELATED TO CIRCUMSTANCES DURING THE PROCEDURE AND NOT A MANUFACTURING RELATED ISSUE. A REVIEW OF MANUFACTURING RECORDS DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER DEPLOYING A RX ACCULINK STENT IN A VERY TORTUOUS LEFT INTERNAL CAROTID ARTERY AND AS THE EMBOSHIELD NAV6 RECOVERY CATHETER (RC) WAS BEING ADVANCED THROUGH THE STENT, IT BECAME CAUGHT IN THE STENT STRUT. TO HELP RELEASE THE RC, THE NON-ABBOTT SHUTTLE SHEATH WAS ADVANCED TO THE PROXIMAL EDGE OF THE STENT. AS THE RC WAS BEING MANEUVERED IN AN ATTEMPT TO RELEASE IT FROM THE STENT, THE FILTER MIGRATED TO THE DISTAL EDGE OF THE STENT. THE RC WAS RELEASED AND THE FILTER WAS CAPTURED AND REMOVED. DUE TO THE MANIPULATION OF THE RC, THE RX ACCULINK STENT WAS DEFORMED AT THE PROXIMAL AND MIDDLE SECTIONS OF THE STENT. A MIDDLEWEIGHT GUIDE WIRE WAS INSERTED AND A RX VIATRAC BALLOON CATHETER THAT WAS USED FOR POST DILATATION WAS REINSERTED INTO THE STENT AND INFLATED AT 4 ATMOSPHERES FOR 8 SECONDS. AFTER THE CATHETER WAS REMOVED, THE STENT'S PROXIMAL END NEEDED ADDITIONAL ADJUSTMENTS AND ANOTHER RX VIATRAC CATHETER WAS INSERTED AND INFLATED TO 10 ATMOSPHERES FOR 7 SECONDS. THE STENT "LOOKED GOOD". THERE WAS NO FURTHER STENT ADJUSTMENTS. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, 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 0031651

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention