BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1230033 · Received November 12, 2008

    Report

    Report Number
    9616695-2008-00159
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    May 28, 2008
    Report Date
    October 19, 2008
    Manufacturer
    ABBOTT VASCULAR - VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT. THE DEVICE REMAINS IN THE PT. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT. WITHOUT THE RETURN OF THE DEVICE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE INACCURATE DELIVERY; HOWEVER, THE LESION WAS DESCRIBED AS HEAVILY CALCIFIED. IT DOES NOT APPEAR TO BE A QUALITY ISSUE.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: STENT MISPLACEMENT. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING A LEFT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE XACT STENT JUMPED UPON DEPLOYMENT SECONDARY TO HEAVY CALCIFICATION. THE STENT COVERED 80% OF THE ORIGINAL LESION LEAVING 20% OF THE LESION UNCOVERED. A SECOND XACT STENT WAS DEPLOYED SUCCESSFULLY TO COVER THE REMAINDER OF THE UNCOVERED LESION. NO ADVERSE PT EFFECTS OCCURRED. THE PT WAS DISCHARGED HOME TWO DAYS LATER PER THE HOSP PROTOCOL. ALTHOUGH REQUESTED NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM NIM ABBOTT VASCULAR - VASCULAR SOLUTIONS NA 36036-6G

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BIVALIRUDIN| EMBOSHIELD EPD