BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS? LD VASCULAR

    MDR report key: 3161628 · Received June 11, 2013

    Report

    Report Number
    2134265-2013-03991
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 16, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: 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 INTRODUCTION PRIOR TO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED AT THE RIGHT FEMORAL ARTERY WITH ANTEROGRADE APPROACH. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT ILIAC VESSEL. AFTER PRE-DILATATION USING AN UNSPECIFIED BALLOON CATHETER, A 8.0 X 20 X 75CM EXPRESS VASCULAR LD STENT DELIVERY SYSTEM WAS ADVANCED BUT WAS UNABLE TO CROSS THE LESION. WHILE DOING SEVERAL ATTEMPTS, THE STENT OF THE DEVICE LIFTED. PHYSICIAN STOPPED USING IT TO PREVENT THE STENT FROM DETACHING. ADDITIONAL PREDILATATION WAS PERFORMED AND THE PROCEDURE WAS COMPLETED USING A 8MM X 20MM X 135 CM EXPRESS LD VASCULAR. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S 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
    261849 EXPRESS? LD VASCULAR CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938162820750 0015808534

    Patients

    Seq Age Sex Outcome Treatment
    1 INTORDUCER SHEATH: 6F