BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4241434 · Received November 10, 2014

    Report

    Report Number
    2024168-2014-07311
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 22, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCORRECT ANATOMY. 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. A QUERY OF THE ELECTRONIC COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE STATES: THE XIENCE XPEDITION STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY ARTERY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS. IN ADDITION, THE XIENCE XPEDITION STENT SYSTEM IS INDICATED FOR TREATING DE NOVO CHRONIC TOTAL CORONARY OCCLUSIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A STENTING PROCEDURE TO TREAT A TARGET LESION IN THE SAPHENOUS VEIN GRAFT (SVG) TO THE RIGHT CORONARY ARTERY (RCA). THE TARGET VESSEL WAS HEAVILY CALCIFIED AND HEAVILY TORTUOUS, AND HAD STENTS IMPLANTED DURING A PREVIOUS PROCEDURE. THE 4.0 X 23 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED INTO THE PATIENT ANATOMY; HOWEVER, DUE TO THE PREVIOUSLY IMPLANTED STENTS, THE DEVICE WAS UNABLE TO CROSS AND WAS REMOVED WITHOUT DIFFICULTY. UPON REMOVAL, FLARED STENT STRUTS WERE NOTED. THE DEVICE WAS NOT USED AGAIN. TWO XIENCE XPEDITION STENTS WERE THEN ABLE TO BE IMPLANTED WITHOUT DIFFICULTY. THE FIRST 3.5 X 12 MM XIENCE XPEDITION SDS WAS THEN ADVANCED; HOWEVER, THIS DEVICE WAS ALSO UNABLE TO CROSS THROUGH THE PREVIOUSLY IMPLANTED STENTS. DURING REMOVAL, THE STENT DISLODGED IN THE MID RCA, AT THE TARGET SITE. A GUIDE CATHETER EXTENSION AND TWO GUIDE WIRES WERE ADVANCED TO THE DISLODGED STENT TO HOLD THE STENT IN PLACE. THE SECOND 3.5 X 12 MM XIENCE XPEDITION STENT WAS THEN ADVANCED TO THE TARGET SITE; HOWEVER, DUE TO THE PREVIOUSLY IMPLANTED STENTS, IT WAS UNABLE TO CROSS AND WAS REMOVED WITHOUT DIFFICULTY. A NEW XIENCE XPEDITION STENT WAS THEN ADVANCED TO THE TARGET SITE AND DEPLOYED SO THAT IT CRUSHED THE DISLODGED XIENCE XPEDITION STENT TO THE VESSEL WALL AND ALSO TREATED THE REMAINING TARGET LESION. NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED AND THERE WERE NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722727 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4081961

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention STENT: XIENCE XPEDITION STENTS X2