BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2070057 · Received April 26, 2011

    Report

    Report Number
    2024168-2011-02953
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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. GUIDE WIRE: .035 SUPRACORE; .014; SHEATH: 7 FR SHORT DIALYSIS; EMBOLIC PROTECTION DEVICE: EMBOSHIELD NAV6 THE EMBOSHIELD IS BEING FILED UNDER A SEPARATE MFR NUMBER. EVALUATION SUMMARY: EVALUATION OF THE RETURNED XACT STENT DELIVERY SYSTEM (SDS) STENT IMPLANT NOTED BLOOD AND TISSUE ON THE STENT, CONSISTENT WITH THE REPORTED USE AND SUBSEQUENT EXPLANTATION. NO DAMAGE WAS NOTED ON THE STENT. THE CATHETER PORTION OF THE DEVICE WAS NOT RETURNED. DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND PRODUCT SIZE SELECTION. IN THIS CASE, THE DISSECTION WAS NOT NOTED INITIALLY ON DEVICE IMPLANTATION. THE DISSECTION WAS NOTICED AFTER REPORTEDLY PLACING A SHEATH IN THE ARTERY USING FORCE. IT IS POSSIBLE IN THIS SITUATION THAT FORCEFUL MANIPULATION OF THE VESSEL MAY HAVE LED TO THE DISSECTION. THE DISSECTION DOES NOT APPEAR TO BE RELATED TO THE XACT DEVICE. DISSECTION IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF A SYMPTOMATIC, 80% STENOSED, PATIENT FOR A LEFT INTERNAL CAROTID PROCEDURE, DIRECT CAROTID PUNCTURE WAS ATTEMPTED. A 7 FR SHORT DIALYSIS SHEATH WAS PLACED AFTER CUTDOWN TO THE CAROTID AND IT WAS NOTED THAT THE ENTRY SITE WAS 'CHUNKY' WITH PLAQUE. THE EMBOSHIELD NAV 6 FILTRATION ELEMENT AS WELL AS A 8-6 X40 MM XACT STENT WERE SUCCESSFULLY PLACED AND DEPLOYED WITHOUT ISSUE. IT WAS NOTED THAT THE SHEATH WAS TOO CLOSE TO THE LESION AND DURING THE ATTEMPT TO PULL THE SHEATH BACK FROM THE LESION, IT WAS PULLED FROM THE ARTERY AND REMOVED. THE PHYSICIAN ATTEMPTED TO USE AN INSTRUMENT TO OPEN UP THE ACCESS SITE IN AN ATTEMPT TO REINSERT THE SHEATH, HOWEVER, INADVERTENTLY CUT THE GUIDE WIRE. THE DISTAL GUIDE WIRE AND FILTRATION ELEMENT REMAINED IN THE ARTERY. HEMOSTATS WERE USED TO REMOVE THE GUIDE WIRE AND THE OPEN FILTRATION ELEMENT THROUGH THE DEPLOYED STENT FROM THE ANATOMY. THE SHEATH WAS POSITIONED IN THE ARTERY USING FORCE AND UNDER FLUOROSCOPY HAD A SUBOPTIMAL APPEARANCE. AN ENDARECTOMY PATCH WAS PLACED AT THE SITE OF THE SHEATH BUT NOT AT THE DEPLOYED STENT. A MICROCATHETER WAS USED FOR A VIEW OF THE STENT, HOWEVER, THE WHOLE NECK APPEARED DISSECTED WITH A SUBOPTIMAL APPEARANCE AND THE STENT WAS EXPLANTED FROM THE CAROTID. A SECOND ENDARECTOMY PATCH WAS PLACED FOR CLOSURE. POST PROCEDURE THE PATIENT WAS MOVING THEIR RIGHT ARM AND HAD MOBILITY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention