BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICAST COVERED STENT

    MDR report key: 2963654 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00057
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    August 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    JCT
    PMA / PMN Number
    K050814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER SYSTEM WAS INSPECTED TO VERIFY THAT THE PRODUCT WAS PROPERLY CRIMPED DURING MFG. WHEN THE PRODUCT IS CRIMPED, THE STENT STRUTS IMPART PERMANENT IMPRINTS TO THE EXTERIOR OF THE BALLOON. WHEN THE DEVICE WAS EXAMINED THE CRIMP MARKS WERE VISIBLE WHICH INDICATES THAT THE STENT WAS PROPERLY CRIMPED ONTO THE BALLOON. WE HAVE NOT BEEN ABLE TO DETERMINE ANY FAULT DUE TO MFG. A REVIEW OF THE PRODUCTION LOT HISTORY DATA FROM QUALITY CONTROL INDICATED SUCCESSFUL PASSAGE OF THE LOT QUALIFICATION SAMPLES THROUGH A 7 FRENCH CORDIS INTRODUCER SHEATH. WITH NO ADDITIONAL PROCEDURAL DETAILS, IT IS DIFFICULT TO RE-ENACT THE EXACT CONDITIONS EXPERIENCED DURING THE CLINICAL PROCURE AND THEREFORE DETERMINE ROOT CAUSE.

    Description of Event or Problem · 1

    THE STENT CAME OFF THE BALLOON AND HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647 ICAST COVERED STENT JCT ATRIUM MEDICAL CORP. 85407 10749032

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ROSEN 035 GUIDEWIRE| TERUMO 7FR SHEATH