BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1231148 · Received October 30, 2008

    Report

    Report Number
    2134265-2008-04148
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    September 8, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAF
    PMA / PMN Number
    P020009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. WHEN THE EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM 2.5X16MM WAS REMOVED FROM THE PACKAGE, IT WAS NOTICED THAT THE STENT STRUTS WERE DAMAGED. ON THE MOST PROXIMAL PART OF THE STENT, ONE OR TWO STRUTS ARE FLARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC CORPORATION NA 11870428

    Patients

    Seq Age Sex Outcome Treatment
    1