BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 3190893 · Received June 26, 2013

    Report

    Report Number
    2024168-2013-03997
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 6, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF RESTENOSIS IS A KNOWN OBSERVED AND POTENTIAL PATIENT EFFECT AS LISTED IN THE RX ACCULINK CAROTID STENT SYSTEM INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, A 6/8X40 RX ACCULINK STENT WAS IMPLANTED IN THE RIGHT INTERNAL CAROTID ARTERY FOR TREATMENT OF A DE NOVO LESION. PRE-STENOSIS WAS 80% AND POST-STENOSIS WAS 10%. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2012. AT THE 1-YEAR FOLLOW-UP ON (B)(6) 2013, 50-79% IN-STENT RESTENOSIS WAS DIAGNOSED. NO TREATMENT WAS PROVIDED AND THE STENOSIS WILL BE RE-EVALUATED WITH ANOTHER DUPLEX ULTRASOUND IN SIX MONTHS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291301 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 2021561

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other