BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2003487 · Received March 1, 2011

    Report

    Report Number
    2024168-2011-01264
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 4, 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. INACCURATE DELIVERY CAN BE THE RESULT OF, BUT NOT LIMITED TO, INTERACTION WITH LESION/ANATOMY, PHYSICIAN TECHNIQUE, SHEATH DAMAGE, AND/OR DAMAGE TO THE HANDLE COMPONENTS. TO ENSURE THIS IS NOT A RESULT OF A MANUFACTURING DEFICIENCY, ALL ACCULINK STENT SYSTEMS ARE 100% VISUALLY INSPECTED FOR DAMAGE AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER STENT DEPLOYMENT. IN THIS CASE, AS A RESULT OF THE INACCURATE DELIVERY, A SECOND RX ACCULINK WAS SUCCESSFULLY DEPLOYED TO FULLY COVER THE LESION. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORT. WITHOUT RETURN OF THE PRODUCT, A DEFINITIVE CAUSE FOR THE REPORTED DEPLOYMENT DIFFICULTY CANNOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE RX ACCULINK STENT JUMPED DURING DEPLOYMENT. A SECOND RX ACCULINK WAS SUCCESSFULLY DEPLOYED TO FULLY COVER THE LESION. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED TO HOME. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION 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 0120161

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention HEPARIN, EMBOSHIELD NAV 6