BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS¿ LD VASCULAR

    MDR report key: 3073272 · Received April 23, 2013

    Report

    Report Number
    2134265-2013-02714
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    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

    (B)(4). 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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, LIFTING OF A STENT PART OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA BRACHIAL APPROACH. THE 99% STENOSED AND CALCIFIED LESION WAS LOCATED IN THE SEVERELY TORTUOUS SUBCLAVIAN ARTERY. A 7.0X40X75 CM EXPRESS LD VASCULAR STENT WAS USED HOWEVER, THE DEVICE WAS NOT ABLE TO CROSS THE TARGET LESION. AFTER SEVERAL ATTEMPTS TO CROSS THE LESION, THE STENT PART WAS OBSERVED TO BE LIFTED. THE DEVICE WAS REMOVED INTACT AS ONE SYSTEM AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATION WAS REPORTED AND THE PATIENT STATUS WAS 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
    173927 EXPRESS¿ LD VASCULAR CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938162740750 15518662

    Patients

    Seq Age Sex Outcome Treatment
    1