BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK MEDICAL ZILVER NITINOL STENT

    MDR report key: 3771097 · Received April 14, 2014

    Report

    Report Number
    3771097
    Event Type
    Injury
    Date Received
    April 14, 2014
    Date of Event
    October 10, 2013
    Report Date
    October 22, 2013
    Manufacturer
    COOK MEDICAL
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH HISTORY OF ESRD ON HD WITH RIGHT THIGH AV GRAFT STENTED IN (B)(6) 2009, DUE TO KINKING, UNDERWENT MECHANICAL THROMBOLYSIS AND ANGIOPLASTY OF THE THROMBOSED DIALYSIS GRAFT ON (B)(6) 2013. DURING THE PROCEDURE, AN APPROX 1CM FRAGMENT OF THE PREVIOUSLY PLACED INTRAGRAFT ZILVER STENT FRACTURED/DISPLACED DURING THE DECLOT PROCEDURE AND EMBOLIZED TO A RIGHT LOWER LOBE PULMONARY ARTERY BRANCH. AN ATTEMPT WAS MADE TO ACCESS VIA THE RIGHT INTERNAL JUGULAR AND SNARE THE FRAGMENT, HOWEVER, THIS WERE NOT SUCCESSFUL. THE PT RETURNED ON (B)(6) 2013, FOR PULMONARY ARTERIOGRAM AND ATTEMPTED FOREIGN BODY REMOVAL. THE FRAGMENT DISLODGED DURING RETRIEVAL FROM THE RIGHT PULMONARY ARTERY AND LANDED IN THE TRICUSPID VALVE APPARATUS. CARDIAC SURGERY WAS CONSULTED AND ON (B)(6) 2013, THE PT WENT TO THE OPERATING ROOM WHERE THE RIGHT ATRIUM WAS OPENED AND INSPECTION OF THE TRICUSPID VALVE REVEALED THE STENT FRAGMENT WAS LODGED IN THE CHORDAE. THIS WAS FREED AND REMOVED AND THE ATRIUM WAS CLOSED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228505 COOK MEDICAL ZILVER NITINOL STENT ZILVER NITINOL STENT 8MM X 60MM FGE COOK MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R