BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 3225002 · Received July 12, 2013

    Report

    Report Number
    2024168-2013-04402
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 17, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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 A 6-8 X 30 RX ACCULINK STENT WAS IMPLANTED IN THE RIGHT INTERNAL CAROTID ARTERY ON (B)(6) 2012. ON (B)(6) 2013, 284 DAYS POST INDEX PROCEDURE, SEVERE IN-STENT RESTENOSIS WAS DIAGNOSED. THE PATIENT HAS HAD NO NEUROLOGIC SYMPTOMS. PERCUTANEOUS TRANSLUMENAL ANGIOPLASTY WAS PERFORMED ON (B)(6) 2013 FOR TREATMENT OF RESTENOSIS AND THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323215 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 1121561

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R