Post-Implant Instructions - AGA Medical AMPLATZER Mode D'emploi

16. If the occluder position and disc conformance to vessel walls is satisfactory:
a. Attach the plastic vise to the delivery wire, and release the occluder by rotating the delivery wire counter-
clockwise until it separates from the occluder.
b. Retract the delivery wire into the delivery catheter
c. Remove the delivery wire and delivery catheter from the patient.
17. Perform angiogram with hemodynamic measurements including direct "pull back" from left pulmonary artery to
main pulmonary artery and ascending aorta to descending aorta to evaluate for obstruction.
18. Perform an aortogram to evaluate occlusion of the ductus arteriosus and verify correct position of the occluder.

10. Post-implant Instructions

• Patient chart labels – Use labels provided for the patient's chart. These labels specify the size, lot number, and
serial number of the device.
• Patient registration card – A patient registration form is located in each device box. Complete the patient
information and send the form to AGA Medical Corporation. A patient registration card will be sent to the patient.
• Provide routine standard of care follow-up for evaluation of residual shunt and obstruction of the vessels.
• Patients should undergo endocarditis prophylaxis for 6 months following occluder implantation. The decision to
continue endocarditis prophylaxis beyond 6 months is at the discretion of the physician.
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