BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1021265 · Received March 28, 2008

    Report

    Report Number
    9616695-2008-00036
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 12, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PT. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: INACCURATE DELIVERY. SYMPTOMS/AE: STENT DID NOT COVER LESION ENTIRELY. TIME OF AE: DURING PROCEDURE. IT WAS REPORTED THAT DURING A RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE STENT WAS PLACED IN AN UNINTENDED SITE. DURING DEPLOYMENT THE GUIDE CATHETER BACKED UP CAUSING THE STENT TO BE PLACED PROXIMAL TO THE INTENDED SITE. SINCE THERE WAS STILL RESIDUAL LESION AT THE DISTAL END, A SECOND STENT WAS PLACED. THERE WERE NO ADVERSE PT EFFECTS REPORTED. ONE DAY POST PROCEDURE, THE PT WAS DISCHARGED TO HOME. ALTHOUGH REQUESTED, THERE IS NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR GALWAY NA 37012-6G

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EMBOSHIELD EMBOLIC PROTECTION DEVICE| XACT STENT| BIVALIRUDIN