BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3061803 · Received April 16, 2013

    Report

    Report Number
    2024168-2013-02325
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: BALANCE MIDDLEWEIGHT 190, GUIDE CATHETER: 6F. 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 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. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE PROCEDURE IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) A BALANCE MIDDLEWEIGHT 190 GUIDE WIRE WAS ADVANCED AND PRE-DILATATION WAS PERFORMED ONCE USING A 3.0X12 NON-ABBOTT BALLOON. A 3.5X15 RX XIENCE XPEDITION STENT DELIVERY SYSTEM WAS ADVANCED SUCCESSFULLY THROUGH A 6F GUIDE CATHETER WITHOUT RESISTANCE. AT THE OSTIUM OF THE RCA, THERE WAS A PREVIOUSLY IMPLANTED STENT. THE XPEDITION STENT SYSTEM WAS ADVANCED INTO THE PREVIOUSLY IMPLANTED STENT AND RESISTANCE WAS FELT. THE PHYSICIAN STOPPED ADVANCING THE STENT SYSTEM AND ATTEMPTED TO WITHDRAW THE STENT SYSTEM. RESISTANCE WAS NOT FELT; HOWEVER, THE STENT DISLODGED APPROXIMATELY 70 PERCENT INSIDE THE PREVIOUSLY IMPLANTED STENT. A 3.5X12 NON-ABBOTT BALLOON WAS ADVANCED AND THE BALLOON WAS INFLATED INSIDE THE DISLODGED STENT, FULLY APPOSING THE XPEDITION STENT TO THE VESSEL WALL. THE DILATATION CATHETER WAS WITHDRAWN AND A 3.0X15 XIENCE XPEDITION STENT SYSTEM WAS SUCCESSFULLY ADVANCED TO THE TARGET LESION THROUGH A 6F GUIDELINER. THE STENT WAS DEPLOYED SUCCESSFULLY. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE ALTHOUGH THERE WAS A SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162642 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2101641

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention