BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT VASCULAR

    MDR report key: 3015678 · Received March 20, 2013

    Report

    Report Number
    MW5029405
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON PLACING XIENCE DES STENT IN PATIENT AND HAD TO REMOVE IT DUE TO A DEFECTIVE PIECE ON THE STENT. THERE WAS NO APPARENT HARM TO THE PATIENT AT THE TIME OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115034 ABBOTT VASCULAR XIENCE XPEDITION ELUTING STENT NIQ ABBOTT VASCULAR 1074250-18 2092741

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention