![]() Partial obstruction of pulmonary artery.Potential adverse events that may occur during or after a procedure placing this device include, but are not limited to: Do not use contrast power injection with delivery catheter.Nursing mothers - There has been no quantitative assessment for the presence of leachables in breast milk.Pregnancy - Minimize radiation exposure to the fetus and the mother.While data are currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted. Symptoms may include difficulty in breathing or swelling of the face or throat. Certain allergic reactions can be serious patients should seek immediate medical attention if there is suspicion of an allergic reaction. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days following implant. The AMPLATZER Piccolo™ Occluder contains nickel-titanium alloy, which is generally considered safe.However, in small infants (≤2 kg), the device should be delivered using the anterograde (venous) approach since small infants are at an increased risk for arterial injury. The device may be delivered via an anterograde (venous) or a retrograde (arterial) approach.Patients should have an activated clotting time (ACT) of greater than 200 sec prior to device placement, unless the patient has a significant risk for bleeding and is unable to be anti-coagulated.The physician should exercise clinical judgment in situations that involve the use of anticoagulants and antiplatelet drugs before, during, and/or after the use of this device.Determine which patients are candidates for procedures that use this device. This device should be used only by physicians who are trained in standard transcatheter techniques.Do not remove an embolized occluder through intracardiac structures unless the occluder is fully recaptured inside a catheter. Do not release the occluder from the delivery wire if either a retention disc protrudes into the pulmonary artery or aorta or if the position of the occluder is not stable.Accurate measurements of the ductus are crucial for correct occluder size selection.Preparation includes access to a transcatheter snare kit and an on-site surgeon. Prepare for situations that require the removal of this device.Patients who are allergic to nickel can have an allergic reaction to this device.Use on or before the last day of the expiration month that is printed on the product packaging label.Do not use the device if the sterile package is open or damaged.Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient. Do not reuse or re-sterilize this device. This device was sterilized with ethylene oxide and is for single use only.Patients with a PDA diameter that is greater than 4 mm at the narrowest portion.Patients with a PDA length smaller than 3 mm.Active infection requiring treatment at the time of implant.Intracardiac thrombus that may interfere with the implant procedure.Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension.Weight The AMPLATZER Piccolo™ Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).
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