BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    MDR report key: 2072279 · Received April 28, 2011

    Report

    Report Number
    2024168-2011-02983
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 SELF EXPANDING STENT SYSTEM (SESS) WAS RETURNED WITH BLOOD ON THE SHAFT AND ON THE TIP, CONSISTENT WITH HANDLING. THERE WAS NO SALINE VISIBLE. THE STENT IMPLANT WAS RETURNED FULLY DEPLOYED, CONSISTENT WITH THE REPORTED INFORMATION THAT THE STENT WAS COMPLETELY DEPLOYED ON THE BACK TABLE. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE OUTER TUBE WAS FULLY RETRACTED. THERE WAS A KINK IN THE SHAFT 4 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE A BEND IN THE METAL SHAFT 6.5 CM DISTAL TO THE LUER LOCK. AS THESE KINKS AND BENDS WERE NOT REPORTED, IT IS POSSIBLE THAT THEY OCCURRED DURING HANDLING/PACKAGING THE PRODUCT FOR RETURN TO ABBOTT VASCULAR. THERE WAS NO OTHER DAMAGE NOTED TO THE SESS. THE TOUHY BORST VALVE WAS IN THE UNLOCKED POSITION. POTENTIAL FACTORS THAT 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. IN THIS CASE, IT MAY BE POSSIBLE THAT THE PREMATURE DEPLOYMENT IS RELATED TO HANDLING AND/OR INADVERTENTLY GRASPING THE TIP OF THE XPERT DURING ADVANCING ONTO THE GUIDE WIRE; HOWEVER, THIS COULD NOT BE CONFIRMED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS FOR THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. A CONCLUSIVE CAUSE FOR THE PREMATURE DEPLOYMENT AND SUBSEQUENT KINKS AND BENDS COULD NOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN AN ATTEMPT WAS MADE TO LOAD THE XPERT ON THE NON-ABBOTT 0.014 GUIDE WIRE, THE STENT APPEARED TO BE A BIT PRE-DEPLOYED. AT THAT TIME, THE DEVICE WAS REMOVED FROM THE GUIDE WIRE. ONCE THE DEVICE WAS REMOVED FROM THE GUIDE WIRE, THE STENT WAS COMPLETELY DEPLOYED ON THE BACKTABLE. A NEW XPERT WAS USED WITH NO ISSUE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. 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 689206

    Patients

    Seq Age Sex Outcome Treatment
    1