Abbott Medical Amplatzer Piccolo Instruction Manual

Amplatzer Piccolo™ Occluder

Instructions for Use

Caution, consult accompanying documents

Not made with natural rubber latex

MR Conditional

Inner diameter

Outer diameter

Length

Usable length

Recommended delivery sheath dimensions

Do not use if package is damaged

Manufacturer

Catalog number

Lot number

Duct Occluder

Use-by date

Date of manufacture

Do not re-use

Sterilized using ethylene oxide

Unique device identification

Quantity

Consult instructions for use

Follow instructions for use on this website

Keep dry; keep away from rain.

Do not resterilize

Caution: Federal law restricts this device to sale by or on the order of a physician.

Amplatzer Piccolo™ Occluder

Device Description

The Amplatzer Piccolo™ Occluder is a self-expanding, nitinol mesh occlusion device for use
in a patent ductus arteriosus (PDA). The
retention discs. The central waist is designed to be positioned within the ductus. The
retention discs are deployed in the pulmonary and aortic ends of the ductus, or may be
deployed completely within the duct when treating small infants. The device may be delivered
via an anterograde (venous) or a retrograde (arterial) approach.

Radiopaque marker bands at each end of the occluder permit visibility during fluoroscopy.

Refer to F1 and F2 for more information about the device. Refer to T1 - T3 in the back for
occluder dimensions and sizing.

F1

F

device configuration is a central waist with two

G

F1 Components

F. Hoop dispenser

G. Vise

H. Delivery wire

J. Occluder

K. Occluder protector tube

H

J

K

F2

L

M

F2 Components

L. Micro screw attachment

M. Radiopaque marker bands

M

Indications and Usage

The Amplatzer Piccolo™ Occluder is a percutaneous, transcatheter occlusion device
intended for the nonsurgical closure of a patent ductus arteriosus (PDA).

Contraindications

• Weight <700 grams at time of the procedure

• Age <3 days at time of procedure

• Coarctation of the aorta

• Left pulmonary artery stenosis

• Cardiac output that is dependent on right to left shunt through the PDA due to
pulmonary hypertension

• Intracardiac thrombus that may interfere with the implant procedure

• Active infection requiring treatment at the time of implant

• Patients with a PDA length smaller than 3 mm

• Patients with a PDA diameter that is greater than 4 mm at the narrowest portion

Warnings

• This device was sterilized with ethylene oxide and is for single use only. Do not reuse or
re-sterilize this device. Attempts to resterilize this device can cause a malfunction,
insufficient sterilization, or harm to the patient.

• Do not use the 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.

• Patients who are allergic to nickel can have an allergic reaction to this device.

• Prepare for situations that require the removal of this device. Preparation includes
access to a transcatheter snare kit and

• Accurate measurements of the ductus are crucial for correct occluder size selection.

an on-site surgeon.

• Do not release the occluder from the delivery wire if either a retention disc protrudes
into the pulmonary artery or aorta; or if the position of the occluder is not stable.

• Remove embolized devices. Do not remove an embolized occluder through intracardiac
structures unless the occluder is fully recaptured inside a catheter.

Precautions

• This device should be used only by physicians who are trained in standard transcatheter
techniques. 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 and antiplatelet drugs before, during, and/or after the use of this device.

• Patients should have an activated clotting time (ACT) of greater than 200 sec prior to
device placement, unless the patient has a significant risk for bleeding and is unable to
be anti-coagulated.

• The device may be delivered via an anterograde (venous) or a retrograde (arterial)
approach. However, in small infants (≤2 kg), the device should be delivered using the
anterograde (venous) approach since small infants are at an increased risk for arterial
injury.

• In small infants (≤2kg) the occluder size is chosen so that the entire device with both
retention discs is placed within the duct (intraductal placement) to minimize the potential
for protrusion into the aorta or left pulmonary artery.

• In larger infants (>2kg), the occluder size is chosen so that the central waist spans the
entire length of the duct with the retention discs placed just outside the duct or within
the ampulla (extraductal disc placement) to achieve improved positional stability and
minimize the potential for device embolization.

• Prior to releasing the device from the delivery wire, it is important to rely on imaging to
ensure there is no obstruction of the aorta or left pulmonary artery.

• The Amplatzer Piccolo™ Occluder contains nickel-titanium alloy, which is generally
considered safe. However, in vitro testing has demonstrated that nickel is released from
this device for a minimum of 60 days following implant. Patients who are allergic to
nickel may have an allergic reaction to this device, especially those with a history of
metal allergies. Certain allergic reactions can be serious; patients should seek
immediate medical attention if there is suspicion of an allergic reaction. Symptoms may
include difficulty in breathing or swelling of the face or throat. While data are currently
limited, it is possible that some patients may develop an allergy to nickel if this device is
implanted.

• 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.

• Store in a dry place.

• Do not use contrast power injection with delivery catheter.