BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2200062 · Received August 10, 2011

    Report

    Report Number
    2024168-2011-05660
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    April 22, 2011
    Report Date
    July 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. FACTORS THAT MAY CONTRIBUTE TO DIFFICULTY DEPLOYING THE STENT INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. IN THIS CASE, IT IS LIKELY THAT ANATOMICAL CONDITIONS CONTRIBUTED TO THE DIFFICULTY, AS IT WAS REPORTED THAT THE LESION SITE WAS HEAVILY CALCIFIED WHICH LIKELY CONTRIBUTED TO THE UNEVEN STENT EXPANSION. AS A RESULT, THE STENT WAS POST-DILATED WITH A 5 X 30 MM VIATRAC BALLOON, STILL SHOWING SOME LESION DEFORMITY, BUT THE RESULTS SHOWED A MUCH IMPROVED EXCELLENT DISTAL FLOW. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THE REPORTED UNEVEN STENT EXPANSION APPEARS TO BE DUE TO ANATOMICAL CONDITIONS AND THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, IN A HEAVILY CALCIFIED LESION, PRE-DILATATION WAS PERFORMED WITH A 4X30MM VIATRAC BALLOON, RESULTING IN UNEVEN EXPANSION OF THE STENOTIC LESION. A 7-9X40MM XACT STENT WAS DEPLOYED WITH EXCELLENT POSITION WITHIN THE LESION. THE STENT WAS POST-DILATED WITH A 5X30MM VIATRAC BALLOON, STILL SHOWING SOME LESION DEFORMITY, BUT THE RESULTS SHOWED A MUCH IMPROVED EXCELLENT DISTAL FLOW. THE POST PROCEDURE STENOSIS WAS 10%. 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 0090761

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention DIL CATH: VIATRAC 4 X 30 MM, 5 X 30 MM