BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2032112 · Received March 28, 2011

    Report

    Report Number
    2024168-2011-02090
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. TERUMO DESTINATION SHEATH, EMBOLIC PROTECTION: EMBOSHIELD NAV 6 . THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. CEREBROVASCULAR ACCIDENT (STROKE), ANEMIA, HEMORRHAGE AND MYOCARDIAL INFARCTION ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE AS POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH CAROTID STENTING. THE INFORMATION RECEIVED SUGGESTS THAT THE SHEATH INCHED FORWARD WHEN THE STENT WAS BEING DEPLOYED CAUSING A PORTION OF THE STENT TO GET CAUGHT IN THE SHEATH, WHICH IN TURN, CAME BACK WITH THE SHEATH WHEN IT WAS PULLED BACK. STENT MIGRATION CAN ALSO BE CAUSED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, DEVICE PLACEMENT TECHNIQUE, ACCESSORY DEVICE SUPPORT, STENT SIZE SELECTION, INSUFFICIENT LANDING ZONE OR INTERACTION WITH ASSOCIATED DEVICES. THE REPORTED STENT MIGRATION APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT AND THERE HAVE BEEN NO OTHER INCIDENTS FOR STENT MIGRATION OR DEVICE DAMAGED BY ANOTHER DEVICE REPORTED FOR THIS LOT. ADDITIONALLY, THE LOT RELEASE TESTING RESULTS WERE REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE XACT STENT WAS DEPLOYED IN THE VERY LOW LEFT CAROTID ARTERY BIFURCATION, THE NON-ABBOTT SHEATH MOVED AND SUBSEQUENTLY PULLED THE XACT STENT INTO THE COMMON CAROTID CAUSING 25% OF THE XACT STENT TO BE ERUPTING OUT OF THE ARTERIAL PUNCTURE AND RESULTING IN PROCEDURAL BLOOD LOSS ANEMIA. THE ACCESS SITE FOR THE PROCEDURE WAS IN THE CUTDOWN OF THE NECK AND THE PROCEDURE WAS PERFORMED IN THE SURGICAL SUITE. THE PATIENT WAS ALSO FOUND TO HAVE A NON ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI) WITH ELEVATED CARDIAC ENZYMES REQUIRING 3 UNITS OF PACKED RED BLOOD CELLS, BETA BLOCKERS, AND NITRATES. THE CASE WAS CONVERTED FROM A STENTING PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA). THE EMBOSHIELD NAV6 WAS MANUALLY REMOVED FROM THE NECK CUTDOWN WITHOUT THE RETRIEVAL CATHETER. THE XACT STENT WAS ALSO REMOVED DURING THE CEA. THE DAY AFTER THE CEA, THE PATIENT HAD A SLIGHT DROOP ON THE RIGHT SIDE OF THE MOUTH AND RIGHT TONGUE DEVIATION. THE BLEEDING RESOLVED THE SAME DAY AS ONSET; HOWEVER, THE STROKE SYMPTOMS ARE CONTINUING AND UNCHANGED. THE PATIENT WAS DISCHARGED HOME FOUR DAYS AFTER THE PROCEDURE. 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 0082061

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R| S