BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS® LD ILIAC / BILIARY

    MDR report key: 3221183 · Received July 11, 2013

    Report

    Report Number
    2134265-2013-04937
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIO
    PMA / PMN Number
    P090003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS.  THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.  THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS RIGHT ILIAC ARTERY. A 7.0 X 30 X 75 CM EXPRESS LD ILIAC / BILIARY STENT WAS USED TO TREAT THE TARGET LESION. WHILE INSIDE THE PATIENT, THE STENT DISLODGED FROM THE BALLOON. A 4.0 X 16MM MUSTANG BALLOON CATHETER WAS INSERTED THROUGH THE STENT, THE BALLOON WAS INFLATED AND THE PHYSICIAN PULLED THE STENT BACK INTO THE SHEATH. THE PHYSICIAN PULLED THE SHEATH OUT AND THEN PERFORMED A CUT DOWN ON THE RIGHT FEMORAL ARTERY AND PULLED THE STENT OUT WITH NO ADVERSE EFFECT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THE PATIENT'S CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320627 EXPRESS® LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC - GALWAY H74938046730750 0015899220

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention