BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICAST COVERED STENT

    MDR report key: 3893991 · Received June 10, 2014

    Report

    Report Number
    1219977-2014-00176
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    JCT
    PMA / PMN Number
    K050814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING THE RETURN OF THE DEVICE FOR INVESTIGATION AND WILL SUBMIT THE FOLLOW-UP REPORT ONCE THE EVALUATION IS COMPLETED. THE OTHER RELATED REPORT: 121997-2014-00176.

    Description of Event or Problem · 1

    REPORT RECEIVED REGARDING A RIGHT ILIO-FEMORAL ARTERY THAT WAS PERFORATED AFTER REMOVAL OF A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) DELIVERY SYSTEM. A STENT WAS USED TO OCCLUDE THE PERFORATION BUT THE STENT WAS NOT ABLE TO CROSS THE AREA SO IT WAS NOT DEPLOYED. THE VESSEL WAS VERY TORTUOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342506 ICAST COVERED STENT COVERED STENT JCT ATRIUM MEDICAL CORPORATION 85420 205822

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention