BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING STENT SYSTEM

    MDR report key: 3071946 · Received April 22, 2013

    Report

    Report Number
    2024168-2013-02486
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 31, 2013
    Report Date
    March 31, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE RESISTANCE WITH THE GUIDE WIRE WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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 DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN THE FEMORAL ARTERY, AN UNKNOWN GUIDE WIRE CROSSED THE LESION. DURING ADVANCEMENT OF A 5X60X120 XPERT STENT SYSTEM, THE STENT SYSTEM BECAME STUCK ON THE GUIDE WIRE BEFORE IT REACHED THE TARGET LESION. AN UNSUCCESSFUL ATTEMPT WAS MADE TO WITHDRAW THE STENT SYSTEM; THEREFORE, THE STENT SYSTEM AND GUIDE WIRE WERE REMOVED FROM THE PATIENT ANATOMY AS A SINGLE UNIT. A NEW GUIDE WIRE WAS ADVANCED AND A NEW XPERT STENT WAS IMPLANTED TO TREAT THE TARGET LESION AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENTS FINAL OUTCOME WAS SATISFACTORY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171160 XPERT SELF-EXPANDING STENT SYSTEM SELF-EXPANDING STENT AND DELIVERY SYSTEM FGE AV-TEMECULA-CT 785312

    Patients

    Seq Age Sex Outcome Treatment
    1