BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM

    MDR report key: 3852958 · Received June 6, 2014

    Report

    Report Number
    3006982370-2014-05016
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    FLEXIBLE STENTING SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K130981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS REPORTED BY A QUALITY REP, DURING TESTING OF A SMART FLEX SELF-EXPANDING STENT (SES) OUTSIDE THE PATIENT, IT WAS REPORTED THAT THE PROXIMAL PORTION OF THE STENT DID NOT EXTEND TO ITS NOMINAL DIAMETER OF 6MM DIAMETER OVER THE STENTS ENTIRE LENGTH. THE ACCOUNT PERFORMED A TEST IN A WATER BATH AT ABOUT 38 DEGREES (LITTLE MORE THAN BODY TEMPERATURE) NOTING THAT THE STENT STILL DID NOT FULLY EXPAND. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE IFU AND PRIOR TO USE, THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM. THE STENT WAS NOT USED DURING A PROCEDURE. UPON RECEIPT OF THE RETURNED 6X200MM STENT FROM STENT LOT S5976 THE FOLLOWING GENERAL OBSERVATIONS WERE MADE: NOTICEABLY REDUCED DIAMETER (RD) AT 4 EYELET (DISTAL) END OF STENT. THE REDUCED DIAMETER AT 4 EYELET END REGION OF STENT TAPERS OVER APPROXIMATELY A 33 MM LENGTH TO A FULL EXPANDED DIAMETER. UNDER MAGNIFICATION, BROKEN STRUT APEX WITH ONE STRUT MEMBER MISSING AT DISTAL END OF STENT WAS OBSERVED. SLIGHT (LARGER DIAMETER AND SHORTER TAPER LENGTH) REDUCED DIAMETER (RD) WAS OBSERVED AT 5 EYELET (PROXIMAL) END OF STENT. UNIFORM EXPANSION OF INTERNAL GEOMETRY OF STENT, WHERE DIAMETER REDUCTION IS NOT OBSERVED. A LEAD QUALITY CONTROL INSPECTOR PERFORMED A VISUAL INSPECTION ALONG THE LENGTH OF THE RETURNED SAMPLE. THE SURFACE FINISH WAS CONSIDERED ACCEPTABLE ALONG THE ENTIRE LENGTH OF THE STENT, INCLUDING REDUCED DIAMETER SECTIONS. THE MEASURED DIAMETER OF THE DISTAL AND PROXIMAL ENDS OF THE STENT ARE 2.21MM AND 0.77MM BELOW THE LOWER SPECIFICATION LIMIT FOR 6MM STENTS, RESPECTIVELY. FUNCTIONAL ANALYSIS - BALLOON DILATION OF THE RETURNED STENT. THE RETURNED SAMPLE WAS CRIMPED INTO 6FR OUTER SHEATH TUBING AND DEPLOYED INTO A 5.5MM SILICONE MOCK VESSEL IN A WATER BATH HEATED TO 37"C. A SECOND 6MM STENT, KNOWN TO FULLY EXPAND, WAS ALSO CRIMPED INTO A 6FR OUTER SHEATH AND DEPLOYED ACROSS THE REDUCED DIAMETER REGION OF THE DISTAL END OF THE RETURNED STENT. THE OVERLAPPING STENT SECTION WAS THEN BALLOON DILATED WITH AN APPROPRIATELY SIZED ANGIOPLASTY BALLOON. THE RETURNED STENT HAD A REDUCED DIAMETER WHEN DEPLOYED IN THE MOCK VESSEL. OTHER ANALYSES WERE PERFORMED TO THE RECEIVED COMPLAINT SAMPLE. A GENERAL REVIEW OF THE TRAVELERS LISTED ABOVE WHICH MAKE UP THE DHR FOR THE PARENT LOT WAS PERFORMED. STENT TRAVELER: ALL STENTS WERE MANUFACTURED IN ACCORDANCE WITH THE TRAVELER, STENTS PASSED ALL PRESCRIBED INSPECTION AND TESTING. SYSTEM AND SUBASSEMBLY TRAVELERS: ALL SYSTEMS WERE MANUFACTURED IN ACCORDANCE WITH THE TRAVELER AND PASSED ALL PRESCRIBED INSPECTION AND TESTING. HOWEVER, DURING MANUFACTURE OF THIS LOT, ONE STENT WAS DEPLOYED AND FOUND TO HAVE A TAPER ON THE 4 EYELET END. THE TIP OF THE STENT MEASURED 6.0MM AT ROOM TEMPERATURE (LSL=6.15MM). THE TAPER BEGAN ONE HALF CM FROM THE END. THIS STENT WAS REJECTED. AN INVESTIGATION WAS PERFORMED CONSISTING OF CRIMPING 15 ARCHIVED STENTS FROM STENT LOT BMT-S5976, REDEPLOYING THOSE STENTS AND INSPECTING FOR AD ISSUES. NO ISSUES WERE OBSERVED. AT THAT POINT, IT WAS CONCLUDED THE ISSUE WAS NOT A LOT ISSUE BUT AN INDIVIDUAL STENT ANOMALY AND THE NC WAS CLOSED AFTER REJECTING THAT STENT. STENT LOT BMT-S5976 WAS USED IN 2 ADDITIONAL DELIVERY SYSTEM LOTS, BMT-S32531 AND BMT-S32642C. BOTH TRAVELERS WERE REVIEWED WITH ALL SYSTEMS MANUFACTURED IN ACCORDANCE WITH THE TRAVELER, PASSING ALL PRESCRIBED INSPECTIONS AND TESTS, AND NO RELATED ISSUES OBSERVED. BASED ON THE FAILURE ANALYSIS, CORDIS COMPLAINT #(B)(4) HAS BEEN CONFIRMED. THE REDUCED DIAMETER OF THE RETURNED STENT CAN BE ATTRIBUTED TO INCREASED HYDROGEN CONTENT CONFIRMED WITH INSTRUMENTAL GAS ANALYSIS (IGA). THE ROOT CAUSE OF THE COMPLAINT IS STILL BEING INVESTIGATED. A RISK ASSESSMENT HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THERE IS NO PATIENT DEMOGRAPHIC AS THE PRODUCT WAS NOT USED IN A PATIENT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY A QUAL REP, DURING THE TESTING OF A SMART FLEX SELF EXPANDING STENT (SES) OUTSIDE THE PATIENT, IT WAS REPORTED THAT THE PROXIMAL PORTION DOES NOT EXTEND TO THE NOMINAL DIAMETER. THE STENT IS OF SHAPE MEMORY, NATURALLY TEMPERATURE OF THE HUMAN BODY, IT MUST REACH 6MM DIAMETER OVER THE ENTIRE LENGTH. THEY CLEARLY SEE THAT THIS IS NOT THE CASE. THEN, THEY CONDUCTED A TEST IN A WATER BATH AT ABOUT 38 DEGREES (LITTLE MORE THAN BODY TEMPERATURE) DESPITE THIS, THE STENT DOES NOT EXTEND (NOTHING CHANGES). THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE IFU. PRIOR TO USE, THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333012 FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE FLEXIBLE STENTING SOLUTIONS 1407908

    Patients

    Seq Age Sex Outcome Treatment
    1