BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 2924061 · Received January 22, 2013

    Report

    Report Number
    2024168-2013-00354
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 27, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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 ADVERSE EVENT AS LISTED IN THE RX ACCULINK CAROTID STENT SYSTEM ELECTRONIC INSTRUCTIONS FOR USE (IFU). 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 APPROXIMATELY 6 MONTHS POST RX ACCULINK STENT IMPLANTATION IN THE HEAVILY CALCIFIED LEFT INTERNAL CAROTID ARTERY, THE PATIENT WAS FOUND TO HAVE 80% IN-STENT RESTENOSIS AND DE NOVO STENOSIS DURING A FOLLOW-UP VISIT. THE PATIENT WAS HOSPITALIZED AND A 4.0MM XIENCE V STENT WAS IMPLANTED FOR TREATMENT REDUCING THE STENOSIS TO 0%. ON (B)(6) 2012, THE EVENT WAS NOTED TO BE RESOLVED AND THE PATIENT WAS DISCHARGED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30980 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 2032061

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R