BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS VASCULAR SD

    MDR report key: 1082650 · Received July 23, 2008

    Report

    Report Number
    2134265-2008-02054
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 23, 2008
    Report Date
    July 31, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE LESION LOCATION WAS NOT SPECIFIED. THE EXPRESS VASCULAR SD STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION, AND THE STENT WAS DEPLOYED SUCCESSFULLY. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO WITHDRAW THE SDS RESISTANCE WAS ENCOUNTERED. THEREFORE, THE PHYSICIAN REMOVED THE SHEATH AND THE EXPRESS VASCULAR SD SDS AS A UNIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIS DEVICE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS IS LISTED AS "OKAY." THIS DEVICE IS OUS ONLY; HOWEVER, THERE IS A SAME OR SIMILAR DEVICE MARKET IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS VASCULAR SD NA MAF BOSTON SCIENTIFIC NA 0011540632

    Patients

    Seq Age Sex Outcome Treatment
    1