BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1065792 · Received June 23, 2008

    Report

    Report Number
    9616695-2008-00093
    Event Type
    Malfunction
    Date Received
    June 23, 2008
    Date of Event
    June 1, 2008
    Report Date
    May 29, 2008
    Manufacturer
    ABBOTT VASCULAR GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT INVOLVES A STUDY NOTED IN AN ARTICLE. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. THE PART AND LOT NUMBER WERE NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. ATTACHMENT: ADRIAN JAMES LING, MBBS, ET AL; "STENTING FOR CAROTID ARTERY STENOSIS: FRACTURES, PROPOSED ETIOLOGY AND THE NEED FOR SURVEILLANCE" JOURNAL OF VASCULAR SURGERY 2008;;47:1220-1226.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: STENT FRACTURE. SYMPTOMS/AE: NONE. TIME OF MALFUNCTION: AFTER THE PROCEDURE. THE FOLLOWING EVENT WAS NOTED THROUGH A PERIODIC ARTICLE REVIEW. A STUDY WAS CONDUCTED TO EVALUATE THE NEED OF SURVEILLANCE FOR STENT FRACTURES AFTER CAROTID ARTERY STENTING. A PT UNDERWENT CAROTID ARTERY STENTING AND DURING RADIOGRAPHIC F/U AT APPROXIMATELY 18 MONTHS POST-IMPLANT, A TYPE III FRACTURE TRANSVERSE LINEAR FRACTURE WITHOUT STENT DISPLACEMENT WAS DETECTED. LOCAL CALCIFICATION IN THE REGION OF THE STENT WAS NOTED. NO TREATMENT OR INTERVENTION WAS DESCRIBED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR (4) CORDIS PRECISE| (2) MEDTRONIC EXPONENT| FRACTURED STENTS: (8) ABBOTT XACT