AMPLATZERTM DUCT OCCLUDER AND DELIVERY SYSTEM
INDICATIONS AND USAGE
The AMPLATZERTM Duct Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).
- Patients weighing less than 6 kg
- Patients less than 6 months of age
- 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
- Active endocarditis or other infections producing bacteremia
- Patients whose vasculature, through which access to the defect is gained, is inadequate to accommodate the appropriate sheath size
- Patients with pulmonary hypertension with pulmonary vascular resistance of greater than 8 Wood units or Rp/Rs of greater than 0.4
- The device should be removed if greater than 3 mm extends into the pulmonary artery, or if more than half of the left pulmonary artery lumen is occupied by the device.
- There is limited clinical data for patients over 40 years of age.
- The AMPLATZERTM Duct Occluder and 180° Delivery System should only be used by those physicians trained in transcatheter defect closure techniques.
- Physicians must be prepared to deal with urgent situations which require removal of embolized devices that result in critical hemodynamic compromise. This includes the availability of an on-site surgeon.
- Embolized devices must be removed. Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within a sheath.
- Do not use if the sterile barrier has been compromised in any way.
- Do not release the AMPLATZERTM Duct Occluder from the delivery cable if the device does not conform to its original configuration or if the device position is unstable. Recapture the device and redeploy. If still unsatisfactory, recapture the device and replace with a new device.
The AMPLATZERTM Duct Occluder and 180° Delivery System were sterilized with ethylene oxide and are for single use only. Do not reuse or resterilize. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
Accurate defect sizing is crucial and mandatory for AMPLATZER™ Duct Occluder device selection. Refer to Table 4 for sizing instructions.
- This device contains 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 seek medical assistance immediately if they suspect they are experiencing an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data is currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted. Some forms of nickel have also been associated with carcinogenicity (ability to cause cancer) in animal models. In humans, carcinogenicity has been demonstrated only through an inhalation route (breathing nickel in) which will not occur with this procedure.
- The physician should exercise clinical judgment in situations that involve the use of anticoagulants or antiplatelet drugs before, during, and/or after the use of this device.
- Endocarditis prophylaxis is carried out for 6 months according to the recommendation of the American Heart Association. The decision to continue endocarditis prophylaxis beyond 6 months is at the discretion of the physician.
- Any patient who has a residual shunt will undergo an echo cardiographic evaluation of the residual shunt until complete closure of the defect has been confirmed.
- Lung perfusion scan should be completed if flow through is greater than 3 m/s, or if the Z-score is -2 for the left pulmonary artery diameter.
- MR Conditional to 3.0 Tesla
Through nonclinical testing, the AMPLATZERTM device has been known to be MR Conditional at field strengths of 3.0 tesla or less with a maximum whole-body-averaged specific absorption rate (SAR) of 3.83 W/kg at 1.5 tesla and 5.57 W/kg at 5.0 tesla for a 20-minute exposure to a B1 of 118μ tesla. The AMPLATZERTM device should not migrate in this MR environment. Nonclinical testing has not been performed to rule out the possibility of migration at field strengths higher than 3.0 tesla.
In this testing, the device produced a temperature rise of 1.1°C at 1.5 tesla and 1.6°C at 5.0 tesla.
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device.
Use in Specific Populations
- Pregnancy — Care should be taken to minimize the radiation exposure to the fetus and the mother.
- Nursing mothers — There has been no quantitative assessment of the presence of leachables in breast milk.
POTENTIAL ADVERSE EVENTS
Placement of the AMPLATZERTM Duct Occluder involves using standard interventional cardiac catheterization techniques. In addition to the above observed adverse events, the following are potential adverse events listed in alphabetical order that were not observed in the clinical study.
The following events might occur from either the catheterization procedure or from the device:
- Air embolus
- Allergic drug reaction
- Allergic dye reaction
- Anesthesia reactions
- Bacterial endocarditis
- Brachial plexus injury
- Chest pain
- Delivery system failure
- Myocardial infarction
- Partial obstruction of aorta
- Partial obstruction of pulmonary artery
- Perforation of vessel or myocardium
- Peripheral embolism
- Stroke/transient ischemic attack
- Valvular regurgitation
- Vascular access site complications