BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING STENT SYSTEM

    MDR report key: 2770810 · Received October 3, 2012

    Report

    Report Number
    2024168-2012-06243
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 11, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. 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 DIFFICULTIES FLUSHING THE DEVICE WERE UNABLE TO BE CONFIRMED; HOWEVER THE PREMATURE STENT DEPLOYMENT WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL 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 THE INTERNAL GUIDE LUMEN OF THE XPERT COULD NOT BE FLUSHED. DURING THE ATTEMPT TO FLUSH IT AND INCREASING THE PRESSURE ON THE SYRINGE, THE STENT BECAME DISLODGED. THE DEVICE WAS NOT USED ON THE PATIENT. A NEW XPERT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPERT SELF-EXPANDING STENT SYSTEM SELF-EXPANDING STENT AND DELIVERY SYSTEM FGE AV-TEMECULA-CT 753980

    Patients

    Seq Age Sex Outcome Treatment
    1