BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 1761126 · Received July 15, 2010

    Report

    Report Number
    3004742046-2010-00314
    Event Type
    Malfunction
    Date Received
    July 15, 2010
    Date of Event
    January 1, 2004
    Report Date
    June 20, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). STENT FRACTURE CAN BE A RESULT OF, BUT IS NOT LIMITED TO, STENT MATERIAL, POST DILATATION TECHNIQUE, ANATOMICAL MOTION RESULTING IN STRESS/FATIGUE OF THE STENT MATERIAL AND/OR INTERACTION WITH OTHER DEVICE POST DEPLOYMENT. IN THIS CASE, THE STENT FRACTURE WAS NOT NOTED AT THE TIME OF STENT IMPLANT, SUGGESTING THAT THE NOTED DAMAGE OCCURRED POST PROCEDURE. HOWEVER, A DEFINITIVE CAUSE FOR THE REPORTED STENT FRACTURE COULD NOT BE DETERMINED. ALL XACT STENTS ARE 100% VISUALLY INSPECTED FOR DAMAGE DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED VERIFY PROPER STENT DEPLOYMENT.

    Description of Event or Problem · 1

    DEVICE ISSUE: STENT FRACTURE. TIME OF DEVICE ISSUE: POST PROCEDURE. THE FOLLOWING EVENT WAS NOTED THROUGH A PERIODIC ARTICLE REVIEW. A PROSPECTIVE STUDY WAS PERFORMED ON 341 PATIENTS IN WHOM CAROTID STENTS WERE IMPLANTED SINCE (B)(6)2004. THE PURPOSE OF THE STUDY WAS TO IDENTIFY AND EVALUATE THE PREVALENCE OF CAROTID STENT FRACTURE, RISK FACTORS, AND CLINICAL RELEVANCE. THIS PATIENT EXPERIENCED XACT STENT FRACTURE, GRADE 2, AS REVEALED ON PLAIN RADIOGRAPHY AT 12 MONTHS. TREATMENT INFORMATION, IF ANY, WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR