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• Patients with any observed pericardial effusion following the device implantation should be
closely monitored with serial echocardiogram performed until the pericardial effusion
resolves.
• Even though there are no known clinical or imaging predictors of patients at risk of erosion,
physicians should monitor high risk patients and use their clinical discretion on the frequency
of follow up and requirement for echocardiographic examinations.
- For these high risk patients monitoring is suggested at implant, 1 day post-implant, pre-
discharge, and again at 1 week, 1 month, 6 months, and 12 months post-implant.
Clinical follow up with a cardiologist annually thereafter is also recommended for the
high risk patients.
- 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 be instructed to avoid strenuous activity for a minimum of 1 month post-
device implant or as directed by their 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.
• Patients should take appropriate endocarditis prophylaxis for 6 months following device
implantation. The decision to continue endocarditis prophylaxis beyond 6 months is at the
discretion of the physician.
• Patients should be treated with antiplatelet/anticoagulation therapy (such as aspirin) for 6
months post-implant. The decision to continue antiplatelet/anticoagulation therapy beyond 6
months is at the discretion of the physician.
• Go to www.amplatzer.com/tempIDcard to print the temporary patient identification card.
Complete this card and give it to the patient.
• If the patient would like to receive a permanent patient identification card, complete the
implant registration form and send the completed form to AGA Medical.
Disposal
• The carton and instructions for use are recyclable. Dispose of all packaging materials as
appropriate.
• Devices may be returned to AGA Medical for disposal. Contact your AGA Medical
representative or [email protected] for instructions.
• Devices may be disposed of following standard solid biohazard waste procedures.
Warranty
AGA Medical Corporation warrants to buyer that, for a period equal to the validated shelf life of the
product, this product shall meet the product specifications established by the manufacturer when
used in accordance with the manufacturer's instructions for use and shall be free from defects in
materials and workmanship. AGA Medical Corporation's obligation under this warranty is limited to
replacing or repairing at its option, at its factory, this product if returned within the warranty period
to AGA Medical Corporation and after confirmed to be defective by the manufacturer.
EXCEPT AS EXPRESSLY PROVIDED IN THIS WARRANTY, AGA MEDICAL CORPORATION
DISCLAIMS ANY REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED,
INCLUDING ANY WARRANTY AS TO MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE.
See the Terms and Conditions of Sale for further information.
For Australia Only
This warranty is given by St. Jude Medical (SJM). To make inquiries regarding this warranty, use
the contact information for either the manufacturer or Australian Sponsor located on the back
cover.
Our goods come with guarantees that cannot be excluded under the Australian Consumer Law.
You are entitled to a replacement or refund for a major failure and compensation for any other rea-
100092311_ASD.book Page 13 Monday, January 6, 2014 11:00 AM
