Racer® Stent System
for Biliary Indication
Instructions for Use ..............................................3
Modo de empleo ..................................................8
Instruções de uso ................................................13
EXPLANATION OF POSSIBLE SYMBOLS ON PRODUCT LABELING.
en CAUTION: Federal (USA) law restricts this device
for sale by or on the order of a physician.
es ATENCIÓN: La ley federal de EE. UU. permite la
venta de este dispositivo únicamente a médicos o
bajo prescripción facultativa.
pt CUIDADO: A lei federal (E.U.A.) limita a venda,
distribuição e uso deste dispositivo a médicos ou
sob sua prescrição.
en Consult Instructions for Use
es Consultar instrucciones sobre modo
de empleo.
pt Consulte as instruções de uso.
en Contents: one (1) stent mounted on an
over-the-wire stent delivery system.
es Contenido: un (1) stent montado en un sistema
de inserción sobre guía.
pt Conteúdo: um (1) stent montado em um sistema
de inserção de stent sobre o o.
en Use by
es Fecha de caducidad
pt Utilize até
f
en Single (1) use only
es Para un (1) solo uso
pt Para uma (1) única utilização
en Sterilized using irradiation
es Esterilizado por irradiación
pt Esterilizado por irradiação
en Non-pyrogenic
es Apirógeno
pt Apirogênico
en Over-the-wire delivery system
es Sistema de inserción sobre guía
pt Sistema de aplicação sobre o o
en Nominal stent length
es Longitud nominal del stent
pt Comprimento nominal do stent
en Nominal stent diameter
es Diámetro nominal del stent
pt Diâmetro nominal do stent
1
en Crossing prole
es Perl de cruce
pt Perl de cruzamento
en Minimum sheath ID
es D. I. mínimo del introductor
pt D. I. mínimo da bainha
en Minimum guide catheter ID
es D. I. mínimo del catéter-guía
pt D. I. mínimo do cateter-guia
en Guidewire compatibility
es Compatibilidad con guías
pt Compatibilidade do o-guia
en Nominal pressure
es Presión nominal
pt Pressão nominal
en Ination pressure
es Presión de inado
pt Pressão de insuação
en Rated burst pressure
es Presión nominal de estallido
pt Pressão de ruptura nominal
en Reference/Catalog number
es Número de catálogo / referencia
pt Referência / número de catálogo
en Lot number
es Número de lote
pt Número do lote
en Peel here
es Despegar aquí
pt Abra aqui
en Manufacturer
es Fabricante
pt Fabricante
en Store at room temperature in a dark, dry place.
es Conservar a temperatura ambiente, en un lugar
oscuro y seco.
pt Armazenar à temperatura ambiente num local
escuro e seco.
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Racer® Stent System
For Use In Biliary Indication
INSTRUCTIONS FOR USE
Caution: Federal (U.S.A.) Law restricts this device to sale by or on the order of a
physician.
INTENDED USE
This device is intended for use in palliation of malignant neoplasms in the biliary tree.
CONTRAINDICATIONS
There are no known contraindications.
POTENTIAL ADVERSE EFFECTS
As with any type of bile duct implant, infection secondary to contamination of the stent may
lead to complications. Over stretching of the bile duct may result in rupture and bleeding.
This stent is made of MP35N metal alloy. Persons with allergic reactions to Cobalt, Nickel,
Chromium and Molybdenum may suffer an allergic response to this implant.
The following complications may be associated with the use of this device:
• Hematoma
• Cholangitis
• Peritonitis
• Abscess/Sepsis/Infection
• Rupture into a neighboring organ or the retroperitoneum
• Bile duct dissection/perforation
• Stent migration
• Re-narrowing of the stented bile duct
• Total occlusion
WARNINGS
• THE SAFETY AND EFFECTIVENESS OF THIS DEVICE FOR USE IN THE
VASCULAR SYSTEM HAS NOT BEEN ESTABLISHED.
• Use of the system requires advanced technical skills. The following instructions will give
technical guidance but do not obviate formal training in the use of the device.
• Do not remove the stent from the balloon delivery catheter. The stent cannot be removed
and placed on another balloon catheter for deployment.
• Special care must be taken not to handle or in any way disrupt the stent position on
the delivery system. This is most important during catheter removal from packaging,
placement over the guidewire and advancement through hemostatic valve adapter, guiding
catheter hub or sheath.
• Use only the appropriate balloon ination media. Do not use air or any gaseous medium
to inate the balloon.
• Balloon pressures should be monitored during ination. Do not exceed maximum
recommended ination pressures as indicated on the product label. Exceeding this pressure
increases the potential for balloon rupture and possible intimal damage.
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• Expansion of the stent should not be undertaken if the stent is not appropriately positioned
in the duct. If the position of the stent is not optimal, it should not be expanded (See
REMOVAL OF AN UNEXPANDED STENT).
• Prior to stent expansion, utilize high-resolution uoroscopy to verify the stent has not
been damaged or dislodged during positioning.
• Incomplete deployment of the stent (i.e., stent not fully expanded) may cause procedural
complications resulting in patient injury.
• The long-term outcome following repeat dilation of epithelialized stents is unknown at
present.
PRECAUTIONS
• Signicant amounts of air in the balloon may cause uneven expansion of the stent
and difculty in deployment of the stent. Do not pre-inate the balloon prior to stent
deployment. Use balloon-prepping technique described within this instructional
material.
• Do not attempt to pull an unexpanded stent back through the guiding catheter or sheath,
since dislodgment of the stent may result (Refer to REMOVAL OF AN UNEXPANDED
STENT).
• Prior to completion of the procedure, utilize uoroscopy to ensure proper positioning
of the deployed stent. If the target stricture is not covered fully, use additional stents as
necessary to adequately treat the stricture.
• The Racer MP35N Stent has been shown to be compatible with diagnostic magnetic
resonance imaging (MRI) in eld strengths up to and including 3.0 Tesla. There are no
contraindications for performing MR imaging immediately post stent implant.
• The device is provided sterile, for one procedure only. Do not resterilize.
• Use prior to the “Use By” date noted on the package.
DEVICE DESCRIPTION
The device consists of a balloon-expandable intraluminal stent premounted onto the balloon
of an over-the-wire delivery catheter. The delivery system has two radiopaque markers on
the inner member and positioned to each side of the stent, to aid in the placement of the stent
during uoroscopy. The delivery system is compatible with labeled guidewires. The device
is provided sterile and non-pyrogenic.
GENERAL USE INFORMATION
Standard techniques for placement of a sheath and guidewire should be employed when using
the device. The stricture and duct must be adequately predilated before use of the stent.
In general, dilation with a balloon diameter ratio 1:1 with the diameter of the duct is required.
For example, the stent size should be chosen to match the diameter of the duct.
Predilations of the duct must take into account proximal strictures which may inhibit
advancement of the stent in addition to strictures beyond the placement area which may prevent
advancement of the device across the primary stricture.
SELECTION OF STENT SIZE
Careful stent sizing is important to successful stenting. In general, the stent size (diameter)
should be chosen to match the diameter of the duct. Slight oversizing is preferable to undersizing.
If necessary, a larger balloon may be used to achieve full apposition, particularly in diffusely
occluded ducts. The stent length must be chosen to match the length of the stricture.
CAUTION: The inated balloon diameter measures slightly larger than the labeled
stent diameter to allow for stent recoil upon expansion.
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