BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    MDR report key: 2241380 · Received September 9, 2011

    Report

    Report Number
    2024168-2011-06240
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. EVALUATION SUMMARY: THE OTW XPERT 4.0 X 30 MM, SELF EXPANDING STENT SYSTEM (SESS) WAS RETURNED WITH BLOOD IN THE GUIDE WIRE LUMEN AND ON THE STENT IMPLANT, WHICH IS CONSISTENT WITH HANDLING AND BEING AT LEAST PARTIALLY ADVANCED OVER A GUIDE WIRE. THERE WAS SALINE ON THE STENT IMPLANT. THE STENT IMPLANT WAS STATIONARY ON THE SHAFT AND PARTIALLY DEPLOYED 1.5 MM DISTAL TO THE DISTAL MARKER AS REPORTED. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE OUTER SHEATH WAS RETRACTED 2.5 MM PROXIMAL TO THE TIP CROWN, SUGGESTING THAT THE OUTER MEMBER MAY HAVE BEEN INADVERTENTLY PULLED BACK DURING PREPARATION. THERE WAS NO DAMAGE NOTED TO THE SESS. THE TUOHY BORST VALVE WAS RETURNED IN THE LOCKED POSITION. POTENTIAL FACTORS WHICH COULD CONTRIBUTE TO PREMATURE DEPLOYMENT PRIOR TO USE INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, HANDLING, INSUFFICIENT SUPPORT DURING PREP, KINKS IN THE SHAFT, LOOSENING OF THE TUOHY BORST VALVE, INTERACTION DURING LOADING ONTO A GUIDE WIRE, OR INTERACTIONS WITH THE INTRODUCER SHEATH AND/OR ASSOCIATED DEVICES DURING INSERTION. TO ENSURE THIS IS NOT A RESULT OF A MANUFACTURING DEFICIENCY, ALL SELF EXPANDING STENT DELIVERY SYSTEMS ARE INSPECTED FOR DAMAGE DURING THE MANUFACTURING PROCESS. IT MAY BE POSSIBLE THAT THE PREMATURE DEPLOYMENT IS RELATED TO HANDLING DURING PREPARATION. ANALYSIS CONFIRMED THE REPORTED PREMATURE DEPLOYMENT; HOWEVER, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. THERE WAS NO ASSOCIATED NONCONFORMING MATERIAL RECORDS FOR THE REPORTED LOT, INDICATING ALL LOT RELEASE TESTING MET SPECIFICATION. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER SIMILAR INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THE XPERT STENT DELIVERY SYSTEM, THE STENT PREMATURELY DEPLOYED. THERE WAS NO PATIENT INVOLVEMENT. A NEW SAME DEVICE WAS USED SUCCESSFULLY TO PERFORM THE PROCEDURE. THERE WAS NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM SELF-EXPANDING STENT AND DELIVERY SYSTEM FGE AV-TEMECULA-CT 687584

    Patients

    Seq Age Sex Outcome Treatment
    1