BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM

    MDR report key: 3873601 · Received June 15, 2014

    Report

    Report Number
    3006982370-2014-05019
    Event Type
    Malfunction
    Date Received
    June 15, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 23, 2014
    Manufacturer
    FLEXIBLE STENTING SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K130981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: THE REPORT RECEIVED INDICATED THAT THE PHYSICIAN COMPLAINED ABOUT THE DEPLOYED LENGTHS OF THE SMART FLEX STENTS NOT MATCHING THE LABELED STENT LENGTH. FOR EXAMPLE, THE 100MM LABEL IS ACTUALLY 110MM IN LENGTH WITH 1.5MM OVER SIZING PER THE INSTRUCTIONS FOR USE (IFU). HE FELT THIS SHOULD BE CORRECTED WITH NEW LABELING OR SHORTENING OF THE STENTS. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS A PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) LESION WHICH WAS SEVERELY CALCIFIED. THERE WAS NO PATIENT INJURY/ADVERSE EVENT FOR THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS WAS THE ONLY CASE REGARDING THIS PRODUCT ISSUE NOTED BY THE PHYSICIAN. FILMS ARE NOT AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE PRODUCT WAS NOT RETURNED FOR INSPECTION. L/N# 1326306 PER BMT DHR14-006: ALL THE REQUIRED INSPECTIONS WERE PERFORMED WITHIN EACH TRAVELER GUIDELINES AND THE TESTING RESULTS COMPLIED WITH THE SPECIFICATIONS PROVIDED. THE TRAVELERS DID NOT INDICATE DEVIATIONS OR UNUSUAL FINDINGS. SINCE NO DEVIATIONS OR UNUSUAL FINDINGS WERE IDENTIFIED, NO CORRECTIVE/PREVENTATIVE ACTIONS ARE REQUIRED. BMT CONCLUDES LOT BMT-S31485 (FINISHED GOOD LOT 1326306) WAS MANUFACTURED IN ACCORDANCE WITH BMT'S QUALITY REQUIREMENTS AND CUSTOMER'S SPECIFICATIONS. THE IFU CLEARLY STATES VIA A TABLE THE STENT LENGTHS IN A DEPLOYED AND A NON-DEPLOYED STATE. IN THIS CASE THERE IS NO INFORMATION PROVIDED THAT AN ACTUAL EVENT OCCURRED THAT INVOLVED THE USE OF A SMARTFLEX STENT IN A PATIENT THAT HAD DEPLOYED TO A LENGTH LONGER THAN EXPECTED. FILMS OF THE EVENT WERE NOT PROVIDED WHICH CAN VERIFY THE STENT LENGTH. IMPROPER STENT DEPLOYMENT TECHNIQUE AND CERTAIN VESSEL CHARACTERISTICS CAN ALSO RESULT IN STENT LENGTHS LONGER THAN EXPECTED. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED MAY HAVE BEEN CAUSED BY PROCEDURAL FACTORS OR THE OPERATIONAL CONTEXT OF THE DEVICE AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT THE PHYSICIAN COMPLAINED ABOUT THE DEPLOYED LENGTHS OF THE SMART FLEX STENTS NOT MATCHING THE LABELED STENT LENGTH. FOR EXAMPLE, THE 100MM LABEL IS ACTUALLY 110MM IN LENGTH WITH 1.5MM OVER SIZING PER THE INSTRUCTIONS FOR USE (IFU). HE FELT THIS SHOULD BE CORRECTED WITH NEW LABELING OR SHORTENING OF THE STENTS. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS A PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) LESION WHICH WAS SEVERELY CALCIFIED. THERE WAS NO PATIENT INJURY/ADVERSE EVENT FOR THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS WAS THE ONLY CASE REGARDING THIS PRODUCT ISSUE NOTED BY THE PHYSICIAN. FILMS ARE NOT AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351920 FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE FLEXIBLE STENTING SOLUTIONS 1326306

    Patients

    Seq Age Sex Outcome Treatment
    1