BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2133949 · Received June 20, 2011

    Report

    Report Number
    2024168-2011-04348
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Adverse Event
    Yes
    Product Problem
    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. 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. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE COMPLAINT HANDLING DATABASE FOUND NO OTHER INCIDENTS OF INACCURATE DELIVERY REPORTED FOR THIS LOT. ALTHOUGH A DEFINITIVE CAUSE FOR THE REPORTED DEPLOYMENT ISSUES CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEPLOYMENT, THE ACCULINK JUMPED FORWARD REQUIRING A SECOND ACCULINK STENT TO COVER THE REST OF THE LESION. THERE WERE NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY. 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 9070651

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention EMBOLIC PROTECTION:RX ACCUNET ((B)(4))