BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3092141 · Received May 3, 2013

    Report

    Report Number
    2024168-2013-02743
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 26, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4) - FAILURE TO FOLLOW STEPS/INSTRUCTIONS. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE (IFU) STATES: DEFLATE THE BALLOON BY PULLING NEGATIVE ON THE INFLATION DEVICE. LARGER AND LONGER BALLOONS WILL TAKE MORE TIME (UP TO 30 SECONDS) TO DEFLATE THAN SMALLER AND SHORTER BALLOONS. CONFIRM BALLOON DEFLATION UNDER FLUOROSCOPY AND WAIT 10 - 15 SECONDS LONGER. ADDITIONALLY, THIS SECTION OF THE IFU, ALSO LISTS THE STEPS TO IMPROVE BALLOON REWRAP IF CATHETER RESISTANCE IS ENCOUNTERED DURING WITHDRAWAL. THEREFORE, IT IS POSSIBLE THAT INCOMPLETE DEFLATION RESULTED IN RESIDUAL CONTRAST LEFT IN THE BALLOON WHICH MAY HAVE BEEN PUSHED INTO THE DISTAL BALLOON TAPER DURING PULLBACK INTO THE GUIDING CATHETER TIP. THIS WOULD CAUSE THE TAPER TO BECOME LARGER IN DIAMETER AND SUBSEQUENTLY CONTRIBUTE TO THE RESISTANCE WHEN PULLING INTO THE GUIDING CATHETER. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN AN UNSPECIFIED VESSEL, A RX XIENCE XPEDITION STENT DELIVERY SYSTEM WAS DELIVERED TO THE TARGET LESION WITHOUT RESISTANCE. THE STENT WAS DEPLOYED SUCCESSFULLY AND WAS CONFIRMED TO BE FULLY APPOSED TO THE VESSEL WALL. BALLOON DEFLATION WAS PERFORMED AND THE BALLOON WAS CONFIRMED TO BE DEFLATED. WHILE ATTEMPTING TO WITHDRAW THE STENT DELIVERY SYSTEM INTO THE GUIDE CATHETER, RESISTANCE WAS FELT. THE STENT SYSTEM BALLOON WAS NOTED TO BE WINGED. THE PHYSICIAN WAS ULTIMATELY ABLE TO MANIPULATE THE BALLOON INTO THE GUIDE CATHETER AND THE STENT DELIVERY SYSTEM WAS WITHDRAWN FROM THE ANATOMY SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT, ADDITIONAL REPORTED INFORMATION INDICATES THAT THE PHYSICIAN HAD AN UNUSUAL DEFLATION PROCESS THAT MAY HAVE CONTRIBUTED TO THE DEFLATION ISSUE RESULTING IN RESISTANCE DURING WITHDRAWAL OF THE DELIVERY CATHETER. THE PHYSICIAN ALTERNATES BETWEEN PULLING NEGATIVE PRESSURE AND NEUTRAL SEVERAL TIMES DURING DEFLATION. AN ABBOTT REPRESENTATIVE EXPLAINED THAT FULL BALLOON DEFLATION MAY NOT BE ACHIEVED AS A RESULT OF THIS TECHNIQUE AND INSTRUCTED THE PHYSICIAN ON THE BEST PRACTICE FOR DEFLATION ACCORDING TO THE INSTRUCTIONS FOR USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194630 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1