BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1065790 · Received June 23, 2008

    Report

    Report Number
    9616695-2008-00098
    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 FRACTURE WAS DETECTED AT A MEAN RADIOGRAPHIC F/U OF 18 MONTHS. NO TREATMENT OR INTERVENTION WAS DESCRIBED. THE ARTICLE DESCRIBED FRACTURES FOR THE XACT STENT ALONG WITH OTHER COMPETITIVE STENTS. THE OUTCOME FOR THIS EVENT DOES NOT IDENTIFY A SPECIFIC MANUFACTURER.

    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 UNK (4) CORDIS PRECISE| FRACTURED STENTS: (8) ABBOTT XACT| (2) MEDTRONIC EXPONENT