BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 3884280 · Received June 19, 2014

    Report

    Report Number
    2024168-2014-03933
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    March 27, 2014
    Report Date
    June 5, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF STENOSIS IS A KNOWN OBSERVED AND POTENTIAL PATIENT EFFECT AS LISTED IN THE RX ACCULINK, DOMESTIC, 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 ON (B)(6) 2013, THE PATIENT UNDERWENT A STENTING PROCEDURE WITH PLACEMENT OF A 7-10 X 40 MM RX ACCULINK STENT IN THE LEFT INTERNAL CAROTID ARTERY. ON (B)(6) 2014, BILATERAL CAROTID DUPLEX ULTRASOUND WAS PERFORMED AND NOTED IN-STENT RESTENOSIS IN THE ACCULINK STENT. DIAGNOSTIC ANGIOGRAPHY WAS PERFORMED ON (B)(6) 2014 AND NOTED IN-STENT RESTENOSIS. ON (B)(6) 2014, THE PATIENT WAS RE-HOSPITALIZED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AT THE TARGET LESION AND THE PATIENT CONDITION RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360215 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 2091762

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R