BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION LL

    MDR report key: 4062549 · Received August 29, 2014

    Report

    Report Number
    4062549
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 29, 2014
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE IN THE PROCESS OF PTCA WITH STENTING OF THE LAD ON PATIENT WITH HISTORY OF CAD, AND FOLLOWING THE RE-INSERTION OF AN INTERVENTIONAL WIRE, AN ABBOTT STENT SYSTEM WAS INSERTED. DOCUMENTATION REFLECTS THAT THE STENT DELIVERY SYSTEM WAS REMOVED WITH AN UNDEPLOYED STENT (AS THE CATHETER BENT). IT IS BELIEVED THAT THE CATHETER BENT AS IT WAS BEING ADVANCED. THE SYSTEM WAS REMOVED WITHOUT INCIDENT. THE PROCEDURE WAS CONTINUED WITH SUCCESSFUL DEPLOYMENT OF ANOTHER STENT. THE SYSTEM WAS CONTAINED AND RETURNED TO THE MANUFACTURER'S REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528068 XIENCE XPEDITION LL CORONARY DRUG-ELUTING STENT NIQ ABBOTT VASCULAR * 4042941

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR CONTRIBUTED TO THE EVENT.| USED BUT IS IT NOT BELIEVED THAT THESE DEVICES| NO OTHER THERAPIES| CORDIS GUIDE CATHETER AND INTERVENTIONAL WIRE WERE