BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRASTENT DOUBLESTRUT PARAMOUNT

    MDR report key: 418527 · Received September 24, 2002

    Report

    Report Number
    2134479-2002-00003
    Event Type
    Injury
    Date Received
    September 24, 2002
    Date of Event
    August 14, 2002
    Report Date
    September 16, 2002
    Manufacturer
    SULZER INTRATHERAPEUTICS INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED WITH A FOCAL EXTERNAL ILIAC LESION. MEASUREMENTS WERE TAKEN. A 6X16 PARAMOUNT SYSTEM WAS SELECTED. THE VESSEL WAS PREDILATED WITH A 5MM BALLOON AND THEN THE VESSEL WAS STENTED. THE STENT WAS POST DILATED AT LOW PRESSURE WITH AN 8MM BALLOON. ACCORDING TO THE PHYSICIAN, THE PT EXPERIENCED PAIN. THE ARTERIOGRAM SHOWS A DISTALLY MIGRATED STENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE STENT WITH A SNARE. THIS ATTEMPT WAS UNSUCCESSFUL SO THE PT WAS SENT TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY CATHETER FGE SULZER INTRATHERAPEUTICS INC. SPM16-16-06-B UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention