Idiomas disponibles
Idiomas disponibles
CAUTION: Do not rotate the cable while advancing the occluder; do not advance the delivery cable and
occluder if resistance is felt.
16. Using echocardiography and fluoroscopy for guidance, hold the delivery cable in place while retracting the delivery
sheath to deploy the left atrial disc and part of the connecting waist.
17. Pull the left atrial disc gently against the atrial septum. This can be felt or observed by echocardiography or fluoroscopy.
18. Maintain a slight tension on the delivery cable while retracting the delivery sheath approximately 5–10 cm to deploy the
right atrial disc.
19. Use echocardiography or angiography to confirm that the device is in place and evaluate for residual shunt or valve
insufficiency.
20. Prior to detaching the occluder, perform a gentle to and fro motion (push-pull test) with the delivery cable to assure a
secure occluder position across the septum.
21. If the occluder position is unstable or interferes with any adjacent cardiac structure (such as SVC, PV, MV, CS, AO), do
not release it from the delivery cable and perform the following steps:
a. Recapture the occluder by stabilizing the delivery cable and advance the delivery sheath until the occluder is
completely within the sheath.
b. Reposition the occluder and deploy it again, or remove the occluder from the patient.
NOTE: The occluder can be deployed a maximum of three times. If the position is still unsatisfactory, then remove and
replace both the device and the sheath.
22. If the occluder does not conform to its original shape, recapture the device and replace it with a new device.
23. Place the plastic vise on the proximal end of the delivery cable.
24. Detach the occluder from the delivery cable by turning the delivery cable counterclockwise (indicated by the arrow on
the plastic vise).
In the unlikely event that this should not be possible, advance the delivery sheath against the right atrial disc to secure
the occluder and to facilitate detachment.
WARNING: When the procedure is complete, slowly remove the delivery cable and delivery sheath from the
patient. Remove the sheath slowly to prevent an ingress of air.
Post-Procedure Care
• Post-procedure follow-up should be per institution standard of care. Prior to discharge, patient should have a TTE.
• Patients with any observed pericardial effusion following the device implantation should be closely monitored with serial
echocardiograms performed to ensure the pericardial effusion is not enlarging or until it resolves.
• Clinical follow-up with a cardiologist, including an echocardiography evaluation, is recommended per the institution's
standard of practice and established guidelines.
• Patients who experience a stroke after device implantation should undergo TEE for evaluation of thrombus formation.
• If a left-sided thrombus is identified following device implant, the patient should be evaluated for a hypercoagulable state
and therapeutic anticoagulation (warfarin) should be initiated for a minimum of three months. A TEE should be performed
following anticoagulation treatment to confirm resolution of the device-related thrombus. Thrombolysis or surgical
removal of the device should be considered if the patient does not respond to anticoagulant therapy.
• Patients should be educated to seek immediate medical attention that includes an echocardiogram, if they develop signs
or symptoms of hemodynamic instability such as chest pain, arrhythmia, fainting, or shortness of breath.
• Patients should take appropriate endocarditis prophylaxis for six months following device implantation. The decision to
continue endocarditis prophylaxis beyond six months is at the discretion of the physician.
• Patients should be treated with antithrombotic therapy, such as aspirin for six months post implant. The decision to
continue antithrombotic therapy beyond six months is at the discretion of the physician.
• Patients should be instructed to avoid strenuous activity for a minimum of one month post-device implant or as directed
by physician. Strenuous activities may lead to the increased risk of adverse events including erosion. Patients should be
reminded that if they experience any symptoms of shortness of breath or chest pain at any time, and especially after
strenuous activity, they should seek medical care immediately.
• For patients with a history of PE or DVT, chronic anticoagulation rather than antiplatelet therapy should be considered
post-device implantation.
Reporting Device Incidents
If, in the course of use of this device, you have reason to believe that a serious incident occurred, please report it to the
manufacturer. For customers in the European Union, report the serious incident to your national authority as well as to the
manufacturer.
Storage and Handling Information
There are no special storage requirements beyond what is typical for medical devices.
This instructions for use is recyclable.
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