BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    MDR report key: 1775099 · Received July 26, 2010

    Report

    Report Number
    3004742046-2010-00339
    Event Type
    Injury
    Date Received
    July 26, 2010
    Date of Event
    June 29, 2010
    Report Date
    July 1, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NTE
    PMA / PMN Number
    K090665
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THE XACT (PART 82090-01, LOT 0022261), THE XACT (PART 82086-01, LOT 0040762), AND THE WHISPER GUIDE WIRE (PART 1005357HJ, LOT UNK) ARE EACH BEING FILED UNDER SEPARATE MFR#'S.

    Description of Event or Problem · 1

    DEVICE ISSUE: DIFFICULT TO REMOVE. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: REQUIRED INTERVENTION. IT WAS REPORTED THAT AFTER THE XACT STENT WAS IMPLANTED IN THE LEFT INTERNAL CAROTID ARTERY, THE NAV6 RETRIEVAL CATHETER WAS ADVANCED TO THE LEVEL OF THE STENT, BUT THERE WAS SIGNIFICANT DIFFICULTY REMOVING THE FILTRATION ELEMENT FROM THE PATIENT'S TORTUOUS ANATOMY, DESPITE MULTIPLE ATTEMPTS AND MANEUVERS SUCH AS POST DILATATION, NECK ROTATION, AND MASSAGE. THE USE OF THE WHISPER WIRE, VOYAGER BALLOON, AND THE RECOVERY CATHETER WERE SUCCESSFUL AT RETRIEVING THE NAV6 FILTER; HOWEVER, THE XACT STENT WAS PULLED DOWN INTO THE LEFT COMMON CAROTID DURING FILTER RETRIEVAL. THE TIP OF THE WHISPER WIRE HAD ENTANGLED AND DISLODGED IN THE XACT STENT REQUIRING THE PLACEMENT OF A NON-ABBOTT STENT IN THE LEFT COMMON CAROTID TO EMBED THE WHISPER WIRE INTO THE VESSEL. A SECOND XACT STENT WAS IMPLANTED IN THE LEFT INTERNAL CAROTID TO COVER THE REST OF THE LESION. AFTER THE PATIENT WAS DISCHARGED HOME, HE EXPERIENCED RIGHT UPPER EXTREMITY PARESIS THAT WAS DIAGNOSED AS A CEREBROVASCULAR ACCIDENT. THE PATIENT'S SYMPTOMS RESOLVED AFTER ONE DAY WITH NO REPORTED INTERVENTION. AN ULTRASOUND AND CT SCAN SHOWED NO FINDINGS. THERE WERE 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 NTE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 0050351

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention STENT: CORDIS SMART XACT| VIATRAC, ULTRATHIN| DIL CATH: VOYAGER| (1005357HJ/UNK)| GUIDE WIRE: GLIDEWIRE| XACT (82086-01/0040762)| BIVALIRUDIN| VESSEL CLOSURE: ANGIO-SEAL| SHEATH: 6F SHUTTLE| SUPERCORE, WHISPER| (82090-01/0022261)