PDF PDA PDF
PDF PDA PDF
PDF PDA PDF
Figure 1
Diagram of a healthy heart
Aorta
Pulmonary Artery
Figure 2
Heart with patent ductus arteriosus
Figure 3
AMPLATZER Duct Occluder implanted during catheter-based procedure
The procedure itself should last about one to two hours and will
take place in a heart catheterization laboratory, where many
minimally-invasive, non-surgical procedures are performed. The
doctor may give the patient an anesthetic, and no significant
discomfort should be felt.
Catheter
entry point
Figure 4
Catheter pathway in transcatheter PDA closure procedure
Figure 5
AMPLATZER Duct Occluder
Loss of peripheral
pulse (loss of pulse in
extremities) (1.0%)a
Anesthesia reaction
Perforation of vessel or
myocardium (piercing of a
vessel or the heart)
Peripheral embolism
(when a small clot or piece
of debris passes through
the peripheral system
causing decreased or
blocked blood flow in an
artery or vein)
Bacterial endocarditis
(infection that causes
redness and swelling of the
lining of the heart and its
valves)
Bleeding
Pseudoaneurysm (false
aneurysm of the femoral
hematoma) (0.3%)a
n
n
Chest pain
Death (0.3%)a
Partial obstruction of
pulmonary artery (0.3%)a
Myocardial infarction
(heart attack)
Hyper/Hypotension
(abnormally high/low blood
pressure)
Valvular regurgitation or
insufficiency (abnormal
backward flow of blood
through a valve)
Device embolization
(dislodging of the device)
(0.3%)a
Fever
Headache/Migraine
Hematoma (collection of
blood outside of a vessel)
a. Adverse event observed with the AMPLATZER Duct Occluder during the clinical trial.
If you are pregnant, you and your baby are at risk for
increased X-ray exposure. Notify your doctor if you are (or
believe you might be) pregnant.
My follow-up questions:
References:
1. Krasuki RA. Patent Ductus Arteriosus Closure. Journal of Interventional Cardiology.
2006;19:(5 Suppl):S60-S66.
2. Schneider DJ, Moore JW. Patent Ductus Arteriosus. Congenital Heart Disease for the Adult
Cardiologist. Circulation. 2006;114:1873-1882.
3. Cincinnati Childrens. Patent Ductus Arteriosus. Cincinnati Childrens. http://www.
cincinnatichildrens.org/health/heart-encyclopedia/anomalies/pda.htm. Accessed March
15, 2011.
4. AMPLATZER Duct Occluder Instructions for Use.
Global Headquarters
One St. Jude Medical Drive
St. Paul, Minnesota 55117
USA
+1 651 756 2000
+1 651 756 3301 Fax
Cardiovascular Division
177 East County Road B
St. Paul, Minnesota 55117
USA
+1 651 756 4470
+1 651 756 4466 Fax
Amplatzer Products
5050 Nathan Lane North
Plymouth, Minnesota 55442
USA
+1 763 513 9227
+1 763 513 9226 Fax
SJMhealth.com
Rx Only
Federal (USA) law restricts this device to sale to or on the order of a physician.
Indications: The AMPLATZER Duct Occluder is a percutaneous, transcatheter occlusion
device intended for the non-surgical closure of patent ductus arteriosus (PDA).
Brief Summary: Please review the Instructions for Use prior to using these devices for a
complete listing of indications, contraindications, warnings, precautions, potential adverse
events and directions for use.
Product referenced is approved for CE Mark.
AMPLATZER, ST. JUDE MEDICAL, and the nine-squares symbol are trademarks and service
marks of St. Jude Medical, Inc. and its related companies. 2011 St. Jude Medical. All rights
reserved.
MM00318 (04.1) Global 10/11