BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3191358 · Received June 26, 2013

    Report

    Report Number
    2024168-2013-04003
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. DIFFICULT TO POSITION (GUIDING CATHETER/GUIDE CATHETER EXTENSION RESISTANCE) WAS CONFIRMED. IT IS LIKELY THAT THE REPORTED DIFFICULTIES WITH THE GUIDING CATHETER/ GUIDING CATHETER EXTENSIONS OCCURRED AS A RESULT OF DAMAGED STENT IMPLANT INADVERTENTLY INTERACTING WITH THE GUIDING CATHETER/ GUIDING CATHETER EXTENSIONS. THE NOTED GUIDE WIRE EXIT NOTCH TEAR LIKELY OCCURRED AS A RESULT OF INADVERTENT MISHANDLING DURING THE PROCEDURE AS RESISTANCE WAS MET. BASED ON VISUAL, DIMENSIONAL, 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. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPT TO PERFORM DIRECT STENTING OF A HEAVILY CALCIFIED, DE NOVO LESION IN THE HEAVILY TORTUOUS MID RIGHT CORONARY ARTERY, A 3.0X38 RX XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED VIA FEMORAL ACCESS OVER AN UNSPECIFIED GUIDE WIRE THEN INTO A 6FR NON-ABBOTT GUIDE CATHETER EXTENSION DEVICE, HOWEVER, THE XPEDITION WAS UNABLE TO BE ADVANCED COMPLETELY THROUGH THE GUIDE CATHETER EXTENSION DEVICE DUE TO RESISTANCE FELT BETWEEN THE TWO DEVICES. THE 3.0X38 XPEDITION SDS WAS WITHDRAWN FROM THE GUIDE CATHETER EXTENSION DEVICE WITHOUT RESISTANCE. A 3.0X33 RX XIENCE XPEDITION SDS WAS THEN ADVANCED INTO THE SAME GUIDE CATHETER EXTENSION DEVICE, BUT WAS ALSO UNABLE TO COMPLETELY ADVANCE THROUGH THE GUIDE CATHETER EXTENSION DEVICE DUE TO RESISTANCE BETWEEN THE TWO DEVICES. THE XPEDITION SDS THEN GUIDE CATHETER EXTENSION DEVICE WERE EACH WITHDRAWN FROM THE ANATOMY WITHOUT RESISTANCE AND A NEW 3.0X38 RX XIENCE XPEDITION WAS SUCCESSFULLY ADVANCED AND DEPLOYED WITHOUT THE USE OF A GUIDE CATHETER EXTENSION DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. THE ABBOTT VASCULAR RETURNED GOODS LAB RECEIVED THE DEVICE WITH ITS GUIDE WIRE EXIT NOTCH TORN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289937 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2112142

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR 6FR VASCULAR SOLUTIONS GUIDELINER