BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1890734 · Received October 28, 2010

    Report

    Report Number
    3004742046-2010-00506
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 3, 2010
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CINE IMAGES OF THE PROCEDURE WERE RECEIVED AND REVIEWED BY AN ABBOTT CLINICAL SPECIALIST. THE REVIEWER NOTED THAT THE FILTRATION ELEMENT WAS NOT VISIBLE IN THE IMAGES CONTAINING THE GUIDE WIRE. THE REVIEWER SAW NOTHING IN THE IMAGES TO INDICATE A ROOT CAUSE FOR THE FILTER DELIVERY ISSUE. REPORTEDLY, THE FILTRATION ELEMENT SUCCESSFULLY LOADED; HOWEVER, AFTER POST DEPLOYMENT OF THE STENT IMPLANT, NO FILTRATION ELEMENT WAS VISIBLE. THE FILTRATION ELEMENT WAS FOUND AT THE DISTAL END OF THE EMBOSHIELD NAV 6 DELIVERY CATHETER. IT IS POSSIBLE THAT AFTER DELIVERY CATHETER PLACEMENT, THE FILTRATION ELEMENT WAS NOT FULLY DEPLOYED DISTAL TO THE LESION AND STILL PARTIALLY COLLAPSED IN THE DELIVERY CATHETER, OR THAT DURING REMOVAL OF THE DELIVERY CATHETER, THE FILTRATION ELEMENT INADVERTENTLY INTERACTED WITH THE DELIVERY CATHETER SUCH THAT THE FILTRATION ELEMENT WAS REMOVED UPON REMOVAL OF THE DELIVERY CATHETER. ALTHOUGH A DEFINITIVE CAUSE COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE LESION MEASURING APPROXIMATELY 3.0MM IN DIAMETER AND 15MM IN LENGTH WAS LOCATED IN A MODERATELY CALCIFIED AND MODERATELY TORTUOUS UNSPECIFIED CORONARY ARTERY. THE LESION WAS PREDILATED WITH BOTH 2.0X20MM AND 2.5X20MM BALLOONS. A 3.0X16MM PROMUS ELEMENT STENT WAS ADVANCED TO THE LESION, BUT COULD NOT CROSS. THE DEVICE WAS REMOVED FROM THE PATIENT AND TWO STENT STRUTS WERE STICKING OUT ON THE PROXIMAL END OF THE STENT. THE PROCEDURE WAS COMPLETED BY DILATING THE LESION AGAIN WITH A 2.5X15MM BALLOON AND DEPLOYING A 3.0X18MM NON BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS STABLE.THIS PRODUCT IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CAROTID ARTERY PROCEDURE THE EMBOSHIELD NAV6 EMBOLIC PROTECTION DEVICE (EPD) WAS THOUGHT TO BE DEPLOYED AND THE DELIVERY CATHETER WAS RETRACTED AND THE INTERVENTION IN THE CAROTID ARTERY WAS PERFORMED WITH A GOOD RESULT. AS THE PHYSICIAN WANTED TO CHECK UNDER FLUOROSCOPY HOW MUCH EMBOLIC MATERIAL WAS INSIDE THE EPD HE NOTICED THERE WAS NO EPD TO BE SEEN. THE PROCEDURE WAS PERFORMED WITHOUT RECOGNIZING THAT THERE WAS NO EPD PROTECTION. THE PATIENT WAS REPORTED AS "WELL"; NO ADVERSE EFFECTS REPORTED. THE PHYSICIAN INSPECTED THE DELIVERY CATHETER OUTSIDE THE ANATOMY AND FOUND THE FILTER HANGING ON THE DELIVERY CATHETER. THERE WAS NO REPORTED PATIENT EFFECT. 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 ABBOTT VASCULAR - VASCULAR SOLUTIONS NA 0071251

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR