BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT PRO SELF-EXPANDING STENT SYSTEM

    MDR report key: 6488971 · Received April 13, 2017

    Report

    Report Number
    2024168-2017-03097
    Event Type
    Malfunction
    Date Received
    April 13, 2017
    Date of Event
    March 16, 2017
    Report Date
    April 12, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    UDI-DI
    08717648150449
    PMA / PMN Number
    K050534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED USE AFTER EXPIRATION APPEARS TO BE RELATED TO THE DEVIATION FROM THE INSTRUCTIONS FOR USE (IFU). THE XPERT IFU, WARNINGS SECTION, STATES: USE PRIOR TO THE USE BY DATE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANTATION OF THE XPERT PRO STENT THE HOSPITAL ORDERED A NEW XPERT PRO AND THEY TOLD THE LOCAL CUSTOMER SERVICE THAT THEY HAD USED AN XPERT PRO WITH LOT# 4103161. FOLLOWING THE INFORMATION FROM THE LOCAL CUSTOMER SERVICE THE CUSTOMER HAS USED THE STENT AFTER THE USE BY DATE (UBD). NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270915 XPERT PRO SELF-EXPANDING STENT SYSTEM SELF-EXPANDING STENT AND DELIVERY SYSTEM FGE AV-TEMECULA-CT 4103161 08717648150449

    Patients

    Seq Age Sex Outcome Treatment
    1