BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 3924385 · Received July 9, 2014

    Report

    Report Number
    2024168-2014-04429
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND THE REPORTED PARTIAL DEPLOYMENT WAS NOT CONFIRMED; HOWEVER, THE STENT WAS NOTED TO BE PARTIALLY EXPOSED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT REVEALED NO OTHER SIMILAR INCIDENTS FOR PARTIAL DEPLOYMENT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THE XACT STENT DELIVERY SYSTEM, THE STENT WAS NOTED TO BE PARTIALLY DEPLOYED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. A SECOND XACT STENT WAS THEN USED WITHOUT DIFFICULTY. RETURN DEVICE ANALYSIS NOTED THAT THE STENT WAS PARTIALLY EXPOSED, BUT NOT PARTIALLY DEPLOYED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400984 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 2031561

    Patients

    Seq Age Sex Outcome Treatment
    1