BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYS.

    MDR report key: 2923310 · Received April 18, 2006

    Report

    Report Number
    6000089-2006-02662
    Event Type
    Malfunction
    Date Received
    April 18, 2006
    Date of Event
    March 19, 2006
    Report Date
    March 20, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT ANALYSIS IS NOT COMPLETE AS OF THIS DATE. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENT PROCEDURE, THE PHYSICIAN WAS UNABLE TO CROSS THE LESION WITH THE EXPRESS2 MONORAIL STENT. UPON REMOVAL, STENT DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYS. PREMOUNTED BALLOON EXPANDABLE STENT SYSTEM MAF BOSTON SCIENTIFIC H7493504032350 7499571

    Patients

    Seq Age Sex Outcome Treatment
    1