BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

    MDR report key: 2200254 · Received August 11, 2011

    Report

    Report Number
    2024168-2011-05663
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 IN THE SHAFT AND ON THE HUB, CONSISTENT WITH THE REPORTED USE. THERE WAS NO SALINE VISIBLE. THE OUTER SHEATH WAS RETRACTED 15.4 CM PROXIMAL TO THE DISTAL MARKER BAND. THERE WERE BENDS IN THE METAL SHAFT 2 CM AND 3 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS WRINKLED OUTER MEMBER 1.6 CM DISTAL TO THE STRAIN RELIEF TUBING. THE CAP ON THE HUB WAS PARTIALLY CLOSED. THE TIP WAS INTACT. THERE WAS NO OTHER DAMAGE NOTED TO THE SESS. THE GUIDING CATHETER USED IN THE PROCEDURE WAS NOT RETURNED. DIFFICULT TO DEPLOY CAN BE A RESULT OF, BUT NOT LIMITED TO, MANUFACTURING, PRE DILATATION STRATEGY, ANATOMICAL CONDITIONS, DEPLOYMENT TECHNIQUE, KINKS OR CHATTER MARKS IN THE SHAFT AND/OR DAMAGE TO THE DEVICE DEPLOYMENT MECHANISMS (HANDLE COMPONENTS/SHAFT LUMENS). IN THIS CASE, IT IS POSSIBLE THAT THE ANATOMICAL CONDITIONS WHICH WERE DESCRIBED AS HEAVILY CALCIFIED CONTRIBUTED TO THE DIFFICULTY. DURING THE ATTEMPT TO DEPLOY, IT IS LIKELY THAT THE FORCE REQUIRED WHILE DEPLOYING THE STENT CONTRIBUTED TO THE BENDS IN THE METAL SHAFT. DURING FUNCTIONAL TESTING, THE METAL SHAFT WAS RETRACTED AND THERE WAS RESISTANCE NOTED ON THE SHAFT WHERE THE BENDS WERE LOCATED. THE CAP WAS OPENED HALF WAY AND RETRACTED THE METAL SHAFT AGAIN. THERE WAS RESISTANCE AT THE BENDS. THE OUTER SHAFT DID NOT ADVANCE. ADDITIONALLY, INACCURATE DELIVERY CAN BE THE RESULT OF, BUT NOT LIMITED TO, INTERACTION WITH LESION/ANATOMY, PHYSICIAN TECHNIQUE, SHEATH DAMAGE, AND/OR DAMAGE TO THE HANDLE COMPONENTS. TO ENSURE THIS IS NOT A RESULT OF A MANUFACTURING DEFICIENCY, ALL XACT STENT SYSTEMS ARE 100% VISUALLY INSPECTED FOR DAMAGE AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER STENT DEPLOYMENT. IN THIS CASE, IT MAY ALSO BE POSSIBLE THAT ANATOMICAL CONDITIONS CONTRIBUTED TO THE INACCURATE DELIVERY AND CAUSED THE STENT TO MOVE FORWARD. BECAUSE IT WAS REPORTED THAT THE XPERT WAS BEING USED TO TREAT THE TIBIAL PERONEAL ARTERY, IT SHOULD BE NOTED THAT THE PRODUCT INSTRUCTIONS FOR USE STATES: THE XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM IS INTENDED FOR USE IN THE PALLIATION OF MALIGNANT STRICTURES IN THE BILIARY TREE. IT MAY ALSO BE POSSIBLE THAT THE DIFFICULTY DEPLOYING IS A RESULT OF USING THE PRODUCT IN AN UN-INDICATED LOCATION; HOWEVER, THIS COULD NOT BE CONFIRMED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING 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 REPORTED DIFFICULTIES COULD NOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. ALL XACT STENT SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT AND DAMAGE. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER STENT DEPLOYMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT COMMON FEMORAL ARTERY WAS USED AS THE ACCESS SITE FOR A PROCEDURE IN THE HEAVILY CALCIFIED RIGHT TIBIAL PERONEAL ARTERY TO TREAT A TOTAL OCCLUSION. ANGIOPLASTY WAS PERFORMED USING A NON-ABBOTT DILATATION CATHETER, WITH SUBOPTIMAL RESULTS. A HAZY AREA IN THE ARTERY WAS PRESUMED TO BE A DISSECTION AND THE PHYSICIAN THEN DECIDED TO PLACE A 4 X 60 MM XPERT STENT. THERE WAS MODERATE RESISTANCE DURING ADVANCEMENT AND DEPLOYMENT OF THE STENT AT THE LESION, POSSIBLY DUE TO THE CALCIFICATION. DURING DEPLOYMENT, THE STENT MOVED FORWARD FROM THE TARGET LESION AND WAS DEPLOYED OUTSIDE OF THE TARGET LESION. A 4 X 30 MM XPERT STENT WAS THEN ADVANCED EASILY INTO THE PATIENT ANATOMY AND WAS DEPLOYED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND NO ADDITIONAL ADVERSE PATIENT EFFECT. 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 679315

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention