BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3100469 · Received May 8, 2013

    Report

    Report Number
    2024168-2013-02877
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 26, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: RUNTHROUGH. GUIDE CATHETER: 3 DRC 6F CORDIS. (B)(4) - FAILURE TO FOLLOW STEPS/INSTRUCTIONS. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. POOR BALLOON REFOLD (WINGING) WAS CONFIRMED. GUIDING CATHETER RESISTANCE WAS NOT CONFIRMED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION 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, THE IFU ALSO LISTS THE STEPS TO IMPROVE BALLOON REWRAP IF CATHETER RESISTANCE IS ENCOUNTERED DURING WITHDRAWAL. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE NON-CALCIFIED, NON-TORTUOUS RIGHT CORONARY ARTERY, FRACTIONAL FLOW RESERVE IMAGING WAS PERFORMED FOLLOWED BY PRE-DILATATION USING A 2.5X12 NON-ABBOTT DILATATION CATHETER. THE NUMBER OF BALLOON INFLATIONS AND ATMOSPHERES WAS NOT KNOWN. THE 3.0X18 RX XIENCE XPEDITION WAS DELIVERED TO THE TARGET LESION OVER A NON-ABBOTT GUIDEWIRE WITHOUT RESISTANCE. THE STENT SYSTEM BALLOON WAS INFLATED TO 15 ATMOSPHERES AND THE STENT WAS DEPLOYED SUCCESSFULLY AND WAS CONFIRMED TO BE FULLY APPOSED TO THE VESSEL WALL. BALLOON DEFLATION WAS PERFORMED FOR APPROXIMATELY 8-10 SECONDS AND THE BALLOON WAS CONFIRMED TO BE DEFLATED. WHILE ATTEMPTING TO WITHDRAW THE STENT DELIVERY SYSTEM INTO THE 6F NON-ABBOTT GUIDE CATHETER, RESISTANCE WAS FELT. THE STENT SYSTEM BALLOON WAS NOTED TO BE WINGED. THE BALLOON WAS NOT RE-INFLATED TO NOMINAL PRESSURE. THE PHYSICIAN WAS ULTIMATELY ABLE TO MANIPULATE THE BALLOON INTO THE GUIDE CATHETER AND THE STENT DELIVERY SYSTEM WAS WITHDRAWN FROM THE ANATOMY SUCCESSFULLY. POST DILATATION WAS PERFORMED USING A 3.0X15 TREK BALLOON AND THE PROCEDURE WAS CONCLUDED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200758 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3010741

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR