BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS® LD BILIARY

    MDR report key: 2920296 · Received January 17, 2013

    Report

    Report Number
    2134265-2013-00140
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K032360
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 MESENTERIC STENTING PROCEDURE, A STENT DETACHMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE TARGET LESION WAS APPROXIMATELY 60% STENOSED AND SEVERELY TORTUOUS. WHILE TRYING TO DELIVER THIS 5.0 X 20 X 75CM EXPRESS BILIARY LD PMTD STENT, THE STENT CAME OFF THE BALLOON WHEN IT WAS PUSHED BACK INTO THE SHEATH. THE SHEATH WAS INSIDE THE PATIENT AND THE SHEATH AND BALLOON WERE REMOVED AT THE SAME TIME WITH THE BALLOON REMAINING IN THE SHEATH. THE PROCEDURE WAS CONTINUED WITH ANOTHER MANUFACTURER'S STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26478 EXPRESS® LD BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938046520750 14407146

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention