BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS? LD VASCULAR

    MDR report key: 3870076 · Received June 12, 2014

    Report

    Report Number
    2134265-2014-03587
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    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. (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 STENT MOVED ON BALLOON OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY WITH CONTRALATERAL APPROACH. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND SEVERELY TORTUOUS RIGHT COMMON ILIAC ARTERY. A NON-BSC GUIDE WIRE WAS ADVANCED TO THE LESION. THE PHYSICIAN ATTEMPTED TO CROSS THE LESION WITH A NON-BSC SHEATH AND AN 8.0X20X135 CM EXPRESS¿ LD VASCULAR STENT BUT FAILED TO CROSS. PREDILATATION WAS PERFORMED USING A 5MMX40MM NON BSC BALLOON CATHETER. WHEN THE PHYSICIAN CHECKED THE 8.0X20X135 CM EXPRESS¿ LD VASCULAR STENT BEFORE USING IT AGAIN, IT WAS NOTED THAT THE STENT MOVED FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A 7MMX17MMX135CM DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348624 EXPRESS? LD VASCULAR CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938162820130 15593290

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE:RADIFOCUS| INFLATION DEVICE:KANEKA| INTRODUCER SHEATH:DESTINATION| BALLOON CATHETER:GENITY