BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPERT SELF-EXPANDING STENT SYSTEM

    MDR report key: 2040450 · Received April 5, 2011

    Report

    Report Number
    2024168-2011-02401
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    FGE
    PMA / PMN Number
    K050534
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED XPERT SELF EXPANDING STENT SYSTEM (SESS) WAS RETURNED WITH BLOOD IN THE GUIDE WIRE LUMEN AND ON THE SHAFT, CONSISTENT WITH THE REPORTED INFORMATION THAT THE DEVICE WAS ADVANCED INTO THE ANATOMY. THERE WAS BLOOD ON THE RETURNED NON-ABBOTT GUIDING CATHETER AND ROTATING HEMOSTATIC VALVE (RHV). THERE WAS NO CONTRAST VISIBLE. THE STENT IMPLANT WAS NOT RETURNED. THE SHEATH WAS RETRACTED PROXIMAL TO THE TIP. THE PROXIMAL END OF THE OUTER TUBE WAS LOOSE FROM THE STRAIN RELIEF TUBING. THE PROXIMAL END OF THE OUTER TUBE WAS WRINKLED. THERE WERE MULTIPLE BENDS IN THE SHAFT. THERE WAS NO OTHER DAMAGE NOTED TO THE SESS. THERE WERE THREE BENDS IN THE SHAFT OF THE NON-ABBOTT GUIDING CATHETER. FAILURE TO DEPLOY CAN BE A RESULT OF, BUT NOT LIMITED TO, MANUFACTURING, PRE DILATATION STRATEGY, ANATOMICAL CONDITIONS, DEPLOYMENT TECHNIQUE, MISHANDLING, KINKS OR BENDS IN THE SHAFT AND/OR DAMAGE TO THE DEVICE DEPLOYMENT MECHANISMS (TUOHY BORST VALVE, TUOHY BORST ADAPTER AND/OR THE METAL SHAFT). A CONCLUSIVE CAUSE FOR THE FAILURE TO DEPLOY COULD NOT BE DETERMINED; HOWEVER, IT MAY BE POSSIBLE THAT ANATOMICAL CONDITIONS CONTRIBUTED TO THE DIFFICULTY. THE PROXIMAL END OF THE OUTER TUBE WAS LOOSE FROM THE STRAIN RELIEF TUBING SUGGESTS FORCE MAY HAVE BEEN APPLIED CAUSING THE OUTER TUBE TO PULL AWAY FROM THE STRAIN RELIEF TUBING. ADDITIONAL MANIPULATION OF THE OUTER TUBE DURING THE ATTEMPTS TO DEPLOY MAY HAVE CONTRIBUTED TO THE WRINKLING NOTED ON THE PROXIMAL END. THE PRODUCT INSTRUCTION FOR USE (IFU) PROVIDES THE FOLLOWING CAUTION: THE STENT SHOULD DEPLOY EASILY. DO NOT DEPLOY IF UNUSUAL FORCE IS REQUIRED, SINCE THIS INDICATES A FAILED SYSTEM. USE A NEW SYSTEM INSTEAD. ADDITIONALLY, IT WAS REPORTED THAT DURING THE REMOVAL ATTEMPT THE STENT PARTIALLY RELEASED AND WAS LOST IN THE PROXIMAL EXTERNAL ILIAC. THE RETURNED UNIT HAD THE DISTAL OUTER SHEATH RETRACTED, WHICH SUGGESTS THAT DURING THE ATTEMPTS TO DEPLOY, THE SHEATH LIKELY RETRACTED ENOUGH FOR THE STENT TO PARTIALLY EXPAND. WITH THE STENT PARTIALLY EXPANDED, DURING DEVICE WITHDRAWAL, THE STENT FULLY DEPLOYED. THE BENDS NOTED IN THE SHAFT OF THE RETURNED XPERT AND NON-ABBOTT GUIDING CATHETER ARE POSSIBLY THE RESULT OF MANIPULATION DURING THE PROCEDURAL ATTEMPTS TO DEPLOY THE STENT AND/OR HANDLING/ PACKAGING THE PRODUCTS FOR RETURN. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED 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 FAILURE TO DEPLOY COULD NOT BE DETERMINED; HOWEVER, THE SUBSEQUENT DAMAGE AND INACCURATE DELIVERY APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. DURING MANUFACTURING, ALL SELF EXPANDING STENT DELIVERY SYSTEMS ARE INSPECTED FOR DAMAGE DURING THE MANUFACTURING PROCESS. ADDITIONALLY, SAMPLES OF THE UNITS ARE FUNCTIONAL TESTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE ILIAC, THE PHYSICIAN TRIED A DIRECT STENTING WITH THE XPERT STENT; HOWEVER, THE STENT COULD NOT BE RELEASED. IT WAS NOTED THAT THE RELEASE MECHANISM DID NOT WORK. THE STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE ANATOMY, CHECKED BY THE PHYSICIAN AND REINSERTED. THE STENT AGAIN COULD NOT BE RELEASED. DURING THE SECOND REMOVAL ATTEMPT THE STENT PARTIALLY RELEASED AND WAS LOST IN THE PROXIMAL EXTERNAL ILIAC. A NON-ABBOTT 6X60 STENT WAS DEPLOYED TO TREAT THE TARGET LESION IN THE LEFT ILIAC ARTERY AND A PORTION OF THE DEPLOYED XPERT STENT. THERE WAS NO RESULTANT ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPERT SELF-EXPANDING STENT SYSTEM SELF-EXPANDING STENT AND DELIVERY SYSTEM FGE AV-TEMECULA-CT 661536

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6FR