Abbott Amplatzer Talisman Instrucciones De Uso página 9

It is intended to be delivered with the Amplatzer™ Talisman™ Delivery Sheath.
The Amplatzer™ Talisman™ PFO Occluder is a self-expandable, double-disc device made from a nitinol wire mesh available
in four sizes to meet a variety of PFO anatomies (as described in Table 2). It is pre-attached to a 120-cm long delivery cable
that facilitates placement of the device in a PFO via femoral vein access. The loader reduces the size of the
Amplatzer™ Talisman™ PFO Occluder, allowing introduction of the device into the sheath. The hemostasis valve with
extension tube and stopcock allows flushing of the delivery system and controls blood backflow during the procedure.
Contraindications
• Presence of thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels
through which access to the defect is gained.
• Patients with intra-cardiac thrombus, mass, vegetation, or tumor.
• Patients whose vasculature, through which access to the PFO is gained, is inadequate to accommodate the appropriate
sheath size.
• Patients with anatomy in which the required Amplatzer™ Talisman™ PFO device size would interfere with other
intracardiac or intravascular structures, such as valves or pulmonary veins.
• Patients with another source of right-to-left shunts, including an atrial septal defect and/or fenestrated septum.
• Patients with active endocarditis or other untreated infections.
• Patients who are unable to tolerate intra-procedural anticoagulation or post-procedural anti-platelet therapy.
Warnings
• Do not use an open or damaged pouch; do not use a damaged device.
• Patients who are at increased risk for venous thromboembolic events should be managed with a thromboembolic risk
reduction regimen after the PFO closure following standard of care.
• The safety and effectiveness of the Amplatzer™ Talisman™ PFO Occluder has not been established in patients with a
hypercoagulable state.
• Prepare for situations that require percutaneous or surgical removal of this device. This includes availability of a surgeon
and access to an operating room.
• Embolized devices must be removed as they may disrupt critical cardiac functions. Do not remove an embolized
occluder through intracardiac structures unless the occluder is fully recaptured inside a catheter or sheath.
• The Amplatzer™ Talisman™ PFO Occluder device consists of a nickel-titanium alloy, which is generally considered safe.
However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days. Patients
who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies.
Certain allergic reactions can be serious; patients should be instructed to notify their physicians immediately if they
suspect they are experiencing an allergic reaction such as difficulty breathing or inflammation of the face or throat. Some
patients may also develop an allergy to nickel if this device is implanted.
• Transient hemodynamic compromise may be encountered during device placement, which may require fluid
replacement or other medications as determined by the physician.
• Prior to device detachment, evaluate the position of the device relative to the free atrial wall and the aortic root using
echocardiography (see Figure 2 and Figure 3 in Appendix A: Supplemental Information).
• Use echocardiography to ensure that the device does not impinge on the free atrial wall or aortic root.
• Do not release the device from the delivery cable if the device does not conform to its original configuration, or if the
device position is unstable or if the device interferes with any adjacent cardiac structure (such as Superior Vena Cava
(SVC), Pulmonary Vein (PV), Mitral Valve (MV), Coronary Sinus (CS), aorta (AO)). If the device interferes with an
adjacent cardiac structure, recapture the device and redeploy. If still unsatisfactory, recapture the device and either
replace with a new device or consider alternative treatments. See Table 2.
• DO NOT use the Amplatzer™ Talisman™ PFO Occluder after the Use-by date stated on the package label.
• This device was sterilized with ethylene oxide and is for single use only; never reuse or re-sterilize the system. Use of
expired, reused, or re-sterilized devices may result in infection.
• This device should be used only by physicians who are trained in standard transcatheter techniques.
Precautions for Special Populations
• Pregnancy: The safety and effectiveness of this occluder has not been established during pregnancy. Fluoroscopic X-ray
guidance may be used during placement of the device. The risk of increased X-ray exposure for patients who are
pregnant must be weighed against the potential benefits of this technique.
• Nursing Mother: The safety and effectiveness of this occluder has not been established in lactating mothers. There has
been no quantitative assessment for the presence of leachables in breast milk.
• Pediatric Population: The safety and effectiveness of this occluder has not been established in a pediatric population.
Precautions
• Aspirin (325 mg/day) (or alternative antiplatelet/anticoagulant, if patient has aspirin intolerance) is recommended to be
started at least 24 hours prior to the procedure.
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