BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS VASCULAR LD PREMOUNTED STENT SYSTEM

    MDR report key: 2102670 · Received May 25, 2011

    Report

    Report Number
    2134265-2011-01952
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT MOVED ON THE DELIVERY DEVICE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS RIGHT ILIAC ARTERY. THE 7.0X30MM EXPRESS VASCULAR LD STENT WAS INSERTED INTO THE PATIENT AND AFTER SEVERAL ATTEMPTS, WAS UNSUCCESSFUL IN CROSSING THE TARGET LESION. THE DEVICE WAS WITHDRAWN AND THE PHYSICIAN NOTED THAT THE EXPRESS STENT HAD MOVED ON THE BALLOON OF THE DELIVERY DEVICE. THE PROCEDURE WAS COMPLETED WITH AN 8.0X40MM NON BSC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS VASCULAR LD PREMOUNTED STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938162730130 0013238649

    Patients

    Seq Age Sex Outcome Treatment
    1 6FR PARENT INTRODUCER SHEATH