- The safety and effectiveness of the Device for cardiac uses (e.g. septal occlusion, patent ductus arteriosis, paravalvular leaks) and neurologic uses have not been established.
- The Delivery Catheter is not intended for use in the coronary vasculature or neuro vasculature.
- Infusion pressure through the Delivery Catheter should not exceed 600 psi; static pressure should not exceed 750 psi.
- Physicians must be prepared to deal with urgent situations, such as device embolization, which may require removal of the Device. This includes the availability of an on-site surgeon.
- The Device is constructed from a nickel-titanium alloy (nitinol). Patients who are allergic to nickel may have an allergic reaction to the Device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should 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 the Device is implanted.
- Following detachment from the Delivery Wire, the Device cannot be recaptured using supplied components.
- Do not perform the procedure if air bubbles are present.
- If flow through the Delivery Catheter becomes restricted, do not attempt to clear the catheter by infusion.
- Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if the sterile package is open or damaged.
- Use before the expiration date printed on the packaging label.
- The Device is for single use only. Do not reuse or resterilize the Device as it may cause harm to the patient.
- The hydrophilic coating on the Delivery Catheter must be kept hydrated in order to be lubricious.
- The physician should exercise clinical judgment in situations that involve the use of anticoagulants or antiplatelet drugs before, during and after use of the Device.
- The Device should only be used by physicians who are trained in standard endovascular techniques. The physician should determine which patients are candidates for procedures that use the Device.
- When the Delivery Catheter is in the patient, manipulate only under fluoroscopic guidance and only over a guide wire.
- When flushing the Delivery Catheter and Loader ensure that all fittings are secure to prevent air introduction.
- Care should be taken to minimize radiation exposure to pregnant women and their fetus.
- Consideration should be given before implanting the Device in nursing mothers because of the potential presence of leachables in breast milk.
- Do not rotate the Delivery Wire during Device advancement, deployment and recapture. Doing so may cause premature detachment.
- The Device has not been tested for compatibility with commercially available microcatheters.
MRI Safety Information
Non-clinical testing has demonstrated the Micro Plug Device is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
- Static magnetic field of 1.5 Tesla or 3.0 Tesla
- Maximum spatial field gradient of 3,000-Gauss/cm (30-T/m)
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg (First Level Controlled Operating Mode)
Under the scan conditions defined above, the Micro Plug Device is expected to produce a maximum temperature rise of less than 3°C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the Micro Plug Device extends approximately 6 mm from the Device when imaged with a gradient echo pulse sequence and a 3.0 Tesla MRI system.
Potential complications include, but are not limited to:
- Air or thrombus embolism
- Device migration
- Allergic reaction
- Foreign material embolization
- Hematoma at the entry site
- Occlusion of unintended vessels
- Stroke / TIA
- Surgical intervention
- Residual flow
- Vessel dissection or perforation