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Warnings
• The use of multiple occluders to treat a single paravalvular leak has not been studied.
• This device was sterilized with ethylene oxide and is for single use only. Do not reuse or
resterilize this device. Attempts to resterilize this device can cause a malfunction,
insufficient sterilization, or harm to the patient.
• Do not use this device if the sterile package is open or damaged.
• Use on or before the last day of the expiration month that is printed on the product
packaging label.
• Prepare for situations that require the removal of this device. Preparation includes
access to an on-site surgeon.
• This device should be used only by physicians who are trained in standard cardiac
interventional techniques. The physician should determine which patients are
candidates for procedures that use this device.
Precautions
• The decision to use an Amplatzer™ Valvular Plug III to treat a paravalvular leak must
be carefully considered as an alternative to surgery by the local heart team, based on
the patient's surgical risk and patient's preference.
• Patients who are allergic to nickel can have an allergic reaction to this device.
• Prolonged procedures can cause increased exposure to anesthesia, contrast media,
and radiation.
• Use this device carefully to prevent interference with previously implanted medical
devices, worsening of the paravalvular spaces during implantation, and damage to
adjacent cardiac tissue or already implanted devices.
• Post-procedure oral anticoagulation and antiplatelet therapy should be prescribed
according to the individual indications for antithrombotic therapy of each patient while
taking into consideration individual patient risks and benefits. Following implantation of
the AVP III device in patients with a previously implanted mechanical heart valve, the
following antithrombotic therapy is recommended:
- Continue long-term anticoagulation therapy for the mechanical heart valve as
previously prescribed, and supplement anticoagulation therapy with a single
antiplatelet agent, such as aspirin 75 mg to 325 mg daily for a minimum of six
months post-implant.
- The decision to continue antiplatelet therapy beyond six months is at the
discretion of the physician based on individual indications, risks, and benefits.
- Antibiotics may also be considered for endocarditis prophylaxis.
• If reoccurrence of a paravalvular leak is suspected after the procedure (for example, in
case of reappearance or persistence of heart failure and/ or hemolysis symptoms), the
patient should contact their physician.
• Use in specific populations:
- Pregnancy – Minimize radiation exposure to the fetus and the mother.
- Nursing mothers – There has been no quantitative assessment for the presence
of leachables in breast milk.
• MR Conditional
Non-clinical testing has demonstrated that the AVPIII devices implanted in conjunction
with the Masters Series valves are MR Conditional. A patient with AVPIII device(s)
1. MR Conditional as defined in ASTM F 2503-13.
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