BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE EXPEDITION SV

    MDR report key: 3172054 · Received May 31, 2013

    Report

    Report Number
    3172054
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ABBOTT VASCULAR, INC
    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

    UPON OPENING AND REMOVING THE XIENCE XPEDITION SV PACKING, THE SCRUB TECH NOTICED THAT THE CATHETER WAS OUT OF THE PROTECTIVE HOOP AND WAS BENT. AT THE REQUEST OF THE PHYSICIAN, THE TECH HANDED OFF THE CATHETER. THE MD TRIED TO STRAIGHTEN THE CATHETER AT WHICH POINT THE CATHETER BROKE. IT IS NOTED THAT AT NO POINT DID THE CATHETER COME IN CONTACT WITH THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PTCA AND STENTING OF PROXIMAL AND MID AND MID DISTAL RCA.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241795 XIENCE EXPEDITION SV CORONARY DRUG-ELUTING STENT NIQ ABBOTT VASCULAR, INC * 2091341

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR CONTACT WITH THE PATIENT.| NOT APPLICABLE. AT NO TIME DID THE DEVICE COME IN