BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENESIS

    MDR report key: 495336 · Received November 5, 2003

    Report

    Report Number
    MW1030078
    Event Type
    Other
    Date Received
    November 5, 2003
    Date of Event
    October 22, 2003
    Report Date
    November 5, 2003
    Manufacturer
    CORDIS CORP
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT S/P TETRALOGY OF FALLOT WITH POST OPERATIVE LEFT PULMONARY ARTERY COARCTATION AND HYPOPLASIA OF LEFT PULMONARY ARTERIES. TO CATH LAB FOR PLACEMENT OF STENT INTO LEFT PULMONARY ARTERY TO IMPROVE VQ MISMATCHING. AT THE TIME OF STENT PLACEMENT IT BECAME DISLODGED AND WAS UNRECOVERABLE IN RIGHT VENTRICLAR OUTFLOW TRACT AND TRAPPED ON A GUIDANT WIRE CATHETER, WHICH COULD NOT BE RESCUED OR DEPLOYED IN A SAFE POSITION. TO OR FOR OPEN RETRIEVAL/REMOVAL OF GUIDE WIRE AND STENT BY CARDIOTHORACIC SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS TRANSHEPATIC BILIARY STENT FGE CORDIS CORP * N0503316

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other