BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1081340 · Received July 24, 2008

    Report

    Report Number
    9616695-2008-00117
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 20, 2008
    Report Date
    July 2, 2008
    Manufacturer
    ABBOTT VASCULAR GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE STENT REMAINS IN THE PT. THE LOT NUMBER WAS PROVIDED. RESTENOSIS IS A KNOWN POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF CAROTID STENTS AS STATED IN XACT INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS NOT RETURNED TO ABBOTT FOR ANALYSIS. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    SYMPTOMS/AE: IN-STENT RESTENOSIS. TIME OF AE: APPROXIMATELY 6 MONTHS AFTER THE PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY 6 MONTHS POST AN UNEVENTFUL RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE PT WAS FOUND TO HAVE 80% IN-STENT RESTENOSIS. THE PT WAS ASYMPTOMATIC, BUT DURING A FOLLOW-UP EXAM, THE PHYSICIAN HEARD A BRUIT. THE PT RETURNED FOR AN ULTRASOUND EXAMINATION AND AN IN-STENT RESTENOSIS WAS FOUND. IN 2008, THE PT WAS REHOSPITALIZED AND WAS STENTED WITHIN THE EXISTING STENT WITH ANOTHER XACT STENT. THERE WERE NO ADVERSE PT SEQUELAE REPORTED. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR GALWAY NA 40512-6G

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EMBOSHIELD EMBOLIC PROTECTION DEVICE| BIVALIRUDIN