BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS® LD ILIAC / BILIARY

    MDR report key: 2873713 · Received December 14, 2012

    Report

    Report Number
    2134265-2012-07564
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Report Date
    November 20, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIO
    PMA / PMN Number
    P090003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILLED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH STENT IMPLANTATION THE STENT MOVED ON THE DELIVERY BALLOON. THE 8.0X30MM EXPRESS LD STENT WAS PLACED INSIDE THE PATIENT. THE STENT MOVED WITHIN THE MARKERBANDS, BUT REMAINED ON THE BALLOON. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED STABLE AND NO COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS® LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC - GALWAY H74938046830750 15503671

    Patients

    Seq Age Sex Outcome Treatment
    1