2
Warnings
• 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.
• The sheath is designed to be used with the loader. Do not attach a syringe directly to the sheath because the sizing is
incompatible and may result in ingress of air or excessive bleeding.
• Use the hemostasis valve to impede the backflow of blood during the implant procedure.
• Do not use a power injection syringe to inject contrast solution through the sheath.
• Remove the dilator and sheath from the patient slowly to prevent an ingress of air.
Precautions
• Store in a dry place.
• This device should be used only by physicians who are trained in standard transcatheter techniques. The physician should
determine which patients are candidates for procedures that use this device.
• The physician should exercise clinical judgment in situations that involve the use of anticoagulants or antiplatelet drugs
before, during, and/or after the use of this delivery system.
• Use caution when advancing the dilator and sheath to avoid damaging tissue and vessels or interfering with previously
implanted medical devices.
• Use standard transcatheter techniques when using Amplatzer™ products.
Potential Adverse Events
Potential adverse events that may occur during or after a procedure using this delivery system may include, but are not limited
to:
Device Compatibility
The Amplatzer™ devices compatible with the Amplatzer™ Trevisio™ Intravascular Delivery System are identified in
Table 1.
CAUTION: No devices other than those listed in this table have been tested for use with the delivery system. Using
untested devices with the delivery system may result in technical failures and/or adverse events.
• Air embolism
• Myocardial infarction
• Arrhythmia
• Perforation
• Arteriovenous fistulae
• Peripheral embolism
• Bleeding • Peripheral
pulse
loss
• Brachial plexus injury
• Stroke
• Cardiac tamponade
• Thrombosis
• Death
• Tissue trauma/damage
• Dissection
• Valve damage
• Endocarditis
• Vascular occlusion
• Hematoma
• Vessel trauma/damage
• Infection
Table 1. Compatibility Chart for Amplatzer™ Trevisio™ I
n
travascular Delivery System and Amplatzer
™
Devices
Amplatzer™ Trevisio™ Intravascular Delivery System Sizes
6 Fr
7 Fr
8 Fr
9 Fr
10 Fr
12 Fr
Amplatzer™ Septal (ASD) Occluder
4–10 mm 11–17 mm
18 mm
19 mm
20–24 mm
26–30 mm 32-38 mm
Amplatzer™ Multi-fenestrated ASD
(Cribriform) Occluder
––
––
18 mm
25 mm
30 mm
35 mm
––
––
Amplatzer™ Muscular VSD Occluder
4–10 mm
12 mm
14 mm
16 mm
18 mm
––
––
Amplatzer™ P.I. Muscular VSD Occluder
––
––
––
16 mm
18 mm
20 mm
22 mm
24 mm
––
Amplatzer™ PFO Occluder
––
––
18 mm
25 mm
35 mm
––
––
