BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICAST COVERED STENT

    MDR report key: 2963646 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00088
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    September 17, 2010
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    JCT
    PMA / PMN Number
    K050814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT CONTAINED THE STENT, A 7FRENCH COOK CHECK FLOW PERFORMER INTRODUCER, AND A STENT SNARING DEVICE. THE STENT WAS STILL LOCATED ON THE END OF THE SNARING DEVICE AND BENT IN THE MIDDLE OF THE STENT. THE STENT ITSELF SHOWED NO SIGNS OF BEING DEPLOYED. THERE WAS SLIGHT DAMAGE TO THE PROXIMAL END OF THE STENT. THERE WAS A SMALL KINK ALSO VISIBLE ON THE COOK INTRODUCER. A REVIEW OF THE DATA FROM QUALITY CONTROL INDICATED SUCCESSFUL PASSAGE OF THE LOT. WITH NO ADDITIONAL PROCEDURAL DETAILS IT IS DIFFICULT TO RE-ENACT THE EXACT CONDITIONS EXPERIENCED DURING THE CLINICAL PROCEDURE AND THEREFORE, DETERMINE ROOT CAUSE.

    Description of Event or Problem · 1

    THE STENT CAME OFF THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970 ICAST COVERED STENT JCT ATRIUM MEDICAL CORP. 85411 10508327

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 7FR COOK PERFORMER INTRODUCER