BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICAST COVERED STENT

    MDR report key: 2963675 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00169
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    January 21, 2010
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    JCT
    PMA / PMN Number
    K050814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPONENTS RETURNED TO ATRIUM MEDICAL INCLUDED A STENT, INTRODUCER AND GUIDE WIRE. NO BALLOON CATHETER OR FILMS WERE INCLUDED. WITHOUT AN INTACT STENT OR BALLOON CATHETER TO REVIEW FOR CRIMP MARKS IT IS NOT POSSIBLE TO MAKE CONCLUSIONS ABOUT THE DEVICE. FURTHERMORE IT IS DIFFICULT TO UNDERSTAND THE COMPLICATIONS ENCOUNTERED WITHOUT FILMS OR A DETAILED CLINICAL PROCEDURE. A REVIEW OF THE LOT QUALIFICATION DATA FOR THIS LOT COMPLETED BY QUALITY CONTROL PRIOR TO SHIPMENT SHOWED IT MET SPECIFICATIONS AND YIELDED NO ANOMALIES. BASED ON THE PROCEDURAL INFO PROVIDED AS WELL AS NO ISSUES OBSERVED WITH EITHER THE DATA RETAINED IN QUALITY CONTROL OR THE OBSERVATIONS RECORDED, ATRIUM CAN FIND NO FAULT WITH THE MFG PROCESS OR THE DEVICE IN QUESTION.

    Description of Event or Problem · 1

    FOR LOT# 1052400505 - THE 10X38 ICAST STENT DISLODGED PRIOR TO INFLATION. STENT APPEARED TO DISLODGE AS THE SHEATH WAS PULLED BACK PRIOR TO DEPLOYMENT. MEDICAL INTERVENTION: SURGEON HAD TO BE CALLED TO DO LEFT GROIN CUTDOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654 ICAST COVERED STENT JCT ATRIUM MEDICAL CORP. 85420 10524005

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 0.035" GUIDEWIRE BRAND NOT PROVIDED| 7FR CORDIS INTRODUCER,