BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1022285 · Received March 26, 2008

    Report

    Report Number
    2134265-2008-00878
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 29, 2008
    Report Date
    February 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P020009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED, THE LESION IN THE RIGHT CORONARY ARTERY WAS PREDILATED. THE PHYSICIAN ENCOUNTERED DIFFICULTY CROSSING THE LESION WITH THE 2.5X16MM EXPRESS2 STENT. WHEN THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE STENT STRUTS WERE BENT UP. THE LESION WAS PREDILATED AGAIN WITH A MAVERICK BALLOON AND ANOTHER MFR'S STENT WAS PLACED. NO PT COMPLICATIONS OCCURRED. PT STATUS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC NA 9528606

    Patients

    Seq Age Sex Outcome Treatment
    1 VISION STENT