BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2230966 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06071
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. THE PRODUCT USED DURING THE PROCEDURE WAS NOT RETURNED WHICH COULD HAVE AIDED IN THE DETERMINATION OF THE CAUSE. INACCURATE STENT DELIVERY MAY BE A RESULT OF, BUT IS NOT LIMITED TO, PATIENT VESSEL GEOMETRY OR VESSEL DIAMETER WHICH COULD HAVE BEEN LARGER THAN THE STENT, WHEN THE STENT DOES NOT APPOSE THE VESSEL WALL WHEN THE STENT IS FULLY DEPLOYED, INADVERTENT MOVEMENT OF THE HANDLE DURING DEPLOYMENT, OR IF POSITIONING OF THE STENT PRIOR TO DEPLOYMENT WAS NOT OPTIMAL. FURTHERMORE, AS PER ACCULINK INSTRUCTION FOR USE, STENT DEPLOYMENT CAUTION NOTES THAT PRIOR TO STENT DEPLOYMENT, REMOVE ALL SLACK FROM THE DELIVERY SYSTEM. A REVIEW OF MANUFACTURING RECORDS DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS WITH THIS PART AND LOT NUMBER COMBINATION. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE MILDLY CALCIFIED AND TORTUOUS RIGHT INTERNAL CAROTID ARTERY, THE RX ACCULINK STENT JUMPED DURING DEPLOYMENT AND ONLY PARTIALLY COVERED THE LESION. A SECOND RX ACCULINK STENT WAS IMPLANTED TO FULLY COVER THE LESION. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 1062361

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention RX ACCUNET EMBOLIC PROTECTION DEVICEHEPARIN