PATENT DUCTUS ARTERIOSUS

A patent ductus arteriosus (PDA) is a blood vessel connecting the aorta with the pulmonary artery. This channel is important prior to birth to allow oxygen-rich blood from the mother to circulate throughout the fetus’s body, but typically closes shortly after birth.

This page is intended to provide you with general information about the nonsurgical closure of a patent ductus arteriosus (PDA), which should be further discussed with a doctor. It is not intended to provide medical care or treatment. You should consult with a doctor regarding the diagnosis or treatment of your medical condition.

PATENT DUCTUS ARTERIOSUS OVERVIEW

A patent ductus arteriosus (PDA) is a blood vessel connecting the aorta with the pulmonary artery. This channel is important prior to birth to allow oxygen-rich blood from the mother to circulate throughout the fetus’s body. Normally, the vessel closes shortly after birth. If it does not close, oxygen-rich blood can mix with oxygen-poor blood, creating extra work for the heart.

  • A PDA is present in approximately 1 in 2,000 births1
  • PDAs account for approximately 5-10% of all congenital heart disease2
  • The female-to-male ratio of patients with PDA is 2:12
How PDA affects the bloodflow

HOW PDA AFFECTS YOUR BLOOD FLOW

The heart is a pump with four chambers: two small upper chambers called the atria (you have a right and a left atrium) and two larger, more powerful pumping chambers called ventricles (again, you have a right and a left ventricle). A healthy heart pumps blood through the body and is controlled by a unique electrical system embedded within the heart itself. Typically, oxygen-poor blood flows from the body into the heart through the right atrium and then fills the right ventricle. When the heart beats, this blood is pumped through the pulmonary artery out to the lungs to be filtered and receive oxygen. From the lungs, the now oxygen-rich blood enters the heart through the left atrium. It then fills the left ventricle and is pumped through the aorta out to the body to provide oxygen to all the organs and cells. After it circulates throughout the body, it becomes oxygen-poor and returns to the heart.

During fetal development, the heart has two openings that normally close shortly after birth. These openings allow the oxygen-rich blood from the mother to bypass the lungs and flow directly through the fetus’s body. The first opening, called the foramen ovale, is between the left and right atria. The second opening, called the ductus arteriosus, is a channel or pathway connecting the aorta with the pulmonary artery. If these do not close after birth, they are known as patent, or open. If a patent ductus arteriosus is present, oxygen-rich blood can pass through the opening and mix with oxygen-poor blood. This causes the heart to overwork.

PDA TREATMENT OPTIONS

There are a number of treatment options for a PDA, and there is no single option that is right for every patient. You should talk with your doctor to learn about the best treatment option for you or your child; however, there are a few standard approaches of which you should be aware. The first option is medication, which may be appropriate to help close the PDA or in treating symptoms associated with the PDA. Other treatment options include open-heart surgery or a minimally-invasive catheter-based procedure, like the Amplatzer™ Duct Occluder.

PDA Treatment

THE AMPLATZER DUCT OCCLUDER, DUCT OCCLUDER II & PICCOLO OCCLUDER

THE AMPLATZER DUCT OCCLUDER, DUCT OCCLUDER II, AND DUCT OCCLUDER II ADDITIONAL SIZES

The Amplatzer Duct Occluders are designed for nonsurgical PDA closure. The devices have different design features, and your doctor will select the most appropriate device for your PDA. The device is placed in the PDA during a catheter-based procedure and will remain permanently implanted.

Each device is made from braided nitinol wires. Nitinol is a metal with shape memory characteristics, meaning the device will return to its original shape even after it is stretched to pass through a catheter. The shape of each device was specifically designed to stop blood flow through a PDA.

PDA Treatment Options

FREQUENTLY ASKED QUESTIONS

  • WHAT ARE SOME SYMPTOMS OF A PDA?

    Severity of symptoms often depends on the size of the PDA. Small PDAs may cause no symptoms and are sometimes only detected by the doctor hearing a heart murmur through a stethoscope. Medium to large PDAs may cause fatigue, poor growth and eventually lead to heart failure.2,3 All sizes of PDAs may increase a patient’s risk for a bacterial infection.

  • HOW IS PDA TREATED?

    There are a number of treatment options for a PDA, and there is no single option that is right for every patient. You should talk with the doctor to learn about the best treatment option; however, there are a few standard approaches of which you should be aware. The first option is medication, which may be appropriate to help close the PDA or in treating symptoms associated with the PDA. Other treatment options include open-heart surgery and catheter-based procedures.

  • HOW DO I KNOW WHICH TREATMENT OPTION IS RIGHT FOR ME?

    Every person is unique. Your doctor is your best resource for learning about the treatment options available to you and the best course for your condition. Talk to your doctor and follow his or her advice for your care. Remember a PDA can result in unpleasant symptoms and increased health risk. With proper care, however, it can generally be managed with medication or closure.

  • WHAT IS INVOLVED WITH A CATHETER-BASED PROCEDURE?

    A catheter-based procedure is a minimally invasive treatment option available to some patients. The procedure involves making a small incision, typically in the groin, and inserting a small tube, called a catheter, to navigate through the blood vessels to the procedure site within the heart.

    In patients with a PDA, the doctor guides the device through the catheter to seal the PDA. Once the device is placed in the PDA, the doctor will carefully study its position using cardiac imaging systems. Once satisfied with the position, the device is released to remain permanently in the channel. The catheter is removed and the procedure is completed.

    The procedure itself should last about one to two hours and will take place in a heart catheterization laboratory, where many minimally invasive, nonsurgical procedures are performed. Your doctor may give
    you an anesthetic, and you should not feel any significant discomfort.

  • WHO SHOULD NOT RECEIVE AN AMPLATZER DUCT OCCLUDER OR DUCT OCCLUDER II?

    If you have any of the following conditions, you may not be a good candidate to receive the Amplatzer Duct Occluder.

    • If you weigh less than 6 kg.
    • If you are less than 6 months of age.
    • If you have blood clots in their heart or vessels.
    • If you have an infection.
    • If have blood clots in your heart.
    • If your heart or your veins are too small or if they cannot undergo the procedure.
    • If your heart or your veins are very small or if there is any reason you cannot undergo the procedure.
    • If you have high blood pressure in the pulmonary arteries.

    If you have any of the above conditions or any of the following conditions, you may not be a good candidate to receive the Amplatzer Duct Occluder II.

    • If you have a window-type PDA.
    • If your blood flows from right to left through the PDA.
    • If you have other heart defects that require surgery.
    • If you have had more than two lower respiratory infections within the past year.
    • If you are unable to take blood thinner medication.
    • If your heart or your veins are very small or if there is any reason you cannot undergo the procedure.
    • If the size of your ductus (channel) is too large for the device.
  • WHO SHOULD NOT RECEIVE THE AMPLATZER PICCOLO™ OCCLUDER?

    If the patient has any of the following conditions, they may not be a good candidate to receive the AMPLATZER Piccolo™ Occluder.

    • If they weigh less than 700 grams at the time of the procedure
    • If they are fewer than 3 days old at the time of the procedure
    • If they have a narrowing in the aorta or in the left pulmonary artery
    • If they have high blood pressure in the pulmonary arteries and the blood flow to the rest of the body must go through the PDA
    • If the PDA length is shorter than 3mm
    • If the PDA diameter at the narrowest portion is greater than 4mm
    • If they have an active infection
    • If they have a clot (thrombus) in their heart that may interfere with the implant procedure
  • WILL MEDICAL EQUIPMENT INTERFERE WITH MY DEVICE?

    Although most medical equipment will have no effect on your device, it is best to tell hospital personnel that you have an implanted device before you undergo any medical procedure. Magnetic resonance imaging (MRI) scans are generally acceptable, and your Amplatzer occlusion device has no known hazards when using a 3-tesla MRI, an MRI system more powerful and faster than standard MRI machines. If an MRI is needed, simply inform the MRI staff about your implant.

  • WHAT HAPPENS AFTER THE PROCEDURE?

    Because the procedure is minimally invasive, recovery will likely be quick and easy. Many patients are discharged from the hospital within 24 hours. Your doctor can provide guidelines for activities and medications. He or she will prescribe drugs that you should take at home to continue your treatment and recovery. The decision to prescribe these is at the discretion of your doctor. Many doctors require
    follow-up appointments over the next year to ensure the patient’s recovery is going well. What to expect during and after the procedure will vary. Discuss all questions and concerns you have with your doctor.

  • HOW LONG WILL IT TAKE ME TO RECOVER, WHAT ACTIVITIES SHOULD BE AVOIDED AFTER THE PROCEDURE, AND WHEN CAN THEY RESUME?

    Every person recovers differently, and your doctor can help determine when activities can be resumed. In general, all strenuous activity should be avoided for one month after the procedure.

  • WILL I BE ABLE TO FEEL THE DEVICE?

    No, you will not be able to feel the device once it’s implanted.

  • WHAT IS A PATIENT IDENTIFICATION CARD? WILL I NEED TO CARRY IT WITH ME?

    As a device patient, it is important to carry a patient identification card with you to identify yourself as having an implanted device. The patient ID card includes your name, implant date, your doctor’s contact information and information about your device. You will be provided with this card after the procedure.

  • CAN I TRAVEL WITH AN IMPLANTED DEVICE? WILL MY DEVICE TRIGGER AIRPORT SECURITY SYSTEMS?

    Your physician is your best resource for the answer to this question. Many patients find that with some extra planning and care they can enjoy traveling even with an implanted device. It is always wise to carry your patient ID card just in case you encounter difficulties while traveling.

    Though some patients worry about airport security systems, there is really no need for concern. The metal parts in Amplatzer occlusion devices are very small and usually do not trigger metal detector alarms. However, the sensitivity setting of the metal detector and other factors may affect how the metal detector responds to your device. Simply show your patient identification card to security personnel.

  • CAN I HAVE THIS PROCEDURE IF I AM PREGNANT? WHAT IF I AM A NURSING MOTHER?

    The risk of increased X-ray exposure must be weighed against the potential benefits of this device. Your physician will ensure that care will be taken to minimize the radiation exposure to the fetus and the mother.

    It is unknown if the device affects breast milk. You should discuss this issue with your doctor.

  • AFTER THE PROCEDURE, WHAT SYMPTOMS SHOULD I SEEK MEDICAL HELP FOR?

    If you experience one or more of the following symptoms after the procedure: pain, numbness, sudden weakness, dizziness or rapid heartbeat, seek medical help immediately. An echocardiogram (ultrasound of the heart) should be performed.

  • WHAT RISKS ARE ASSOCIATED WITH THE AMPLATZER DUCT OCCLUDER AND DUCT OCCLUDER II?

    There are certain potential risks associated with catheter-based procedures as well as additional risks that may be associated with the device. Your doctor is the best source of information about the risks of having an implanted device. Be sure to talk about all your questions and concerns.

    Potential risks include, but are not limited to:

    • Air embolus (an air bubble that blocks blood flow in a vessel)
    • Allergic drug reaction
    • Allergic dye reaction
    • Anesthesia reaction
    • Apnea (temporary absence of breathing)
    • Arrhythmia (loss of regular heart rhythm)
    • Bacterial endocarditis (infection that causes swelling of the lining of the heart and its valves)
    • Bleeding
    • Brachial plexus injury (injury to the nerves in the arm or lower neck)
    • Chest pain
    • Death*
    • Delivery system failure
    • Fever
    • Headache/Migraine
    • Hyper/Hypotension (abnormally high/low blood pressure)
    • Myocardial infarction (heart attack)
    • Partial obstruction of pulmonary artery
    • 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)
    • Stroke/Transient ischemic attack (temporary lack of oxygen to the brain)
    • Thrombus (blood clot)
    • Valvular regurgitation or insufficiency (abnormal backward flow of blood through a valve)
    • Vascular access site complications

     

    You should also be aware that:

    • The Amplatzer Duct 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. 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 be instructed to seek medical assistance immediately if they suspect they are experiencing 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.
    • Patients allergic to nickel may suffer an allergic reaction to this device.
    • There is limited clinical data for patients over 40 years of age.
    • 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.
    • If the device were to be dislodged, you may need surgery for its removal. Your PDA will be repaired at the same time. Surgery following device placement may be more difficult.

    For additional information, please contact your doctor.

REFERENCES:

1. Krasuki, R. A. (2006). Patent ductus arteriosus closure. Journal of Interventional Cardiology, 19 (5 Suppl), S60-S66.
2. Schneider, D. J., & Moore, J. W. (2006). Patent ductus arteriosus. Circulation, 114(17), 1873-1882.
3. Cincinnati Children’s. Congenital Patent Ductus Arteriosus. www.cincinnatichildrens.org/health/heart-encyclopedia/anomalies/pda.htm. Accessed February 2, 2016.


IMPORTANT SAFETY INFORMATION



AMPLAZTER™ DUCT OCCLUDER
INTENDED FOR USE

The AMPLAZTER™ Duct Occluder is a percutaneous transcatheter occlusion intended for the non-surgical closure of a patent ductus arteriosus (PDA).

CONTRAINDICATIONS
  • Patients weighing less than 6 kg
  • Patients less than 6 months of age
  • Presence of thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the defect is gained
  • Active endocarditis or other infections producing bacteremia
  • Patients whose vasculature, through which access to the defect is gained, is inadequate to accommodate the appropriate sheath size
  • Patients with pulmonary hypertension with pulmonary vascular resistance of greater than 8 Wood units or Rp/Rs of greater than 0.4
WARNINGS
  • The device should be removed if greater than 3 mm extends into the pulmonary artery, or if more than half of the left pulmonary artery lumen is occupied by the device.
  • There is limited clinical data for patients over 40 years of age.
  • The AMPLATZER™ Duct Occluder and 180° Delivery System should only be used by those physicians trained in transcatheter defect closure techniques.
  • Physicians must be prepared to deal with urgent situations which require removal of embolized devices that result in critical hemodynamic compromise. This includes the availability of an on-site surgeon.
  • Embolized devices must be removed. Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within a sheath.
  • Do not use if the sterile barrier has been compromised in any way.
  • Do not release the AMPLATZER™ Duct Occluder from the delivery cable if the device does not conform to its original configuration or if the device position is unstable. Recapture the device and redeploy. If still unsatisfactory, recapture the device and replace with a new device.
PRECAUTIONS

Handling
The AMPLATZER™ Duct Occluder and 180° Delivery System were sterilized with ethylene oxide and are for single use only. Do not reuse or resterilize. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.

Sizing
Accurate defect sizing is crucial and mandatory for AMPLATZER™ Duct Occluder device selection. Refer to Table 4 for sizing instructions.

Procedural

  • This device 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. 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 be instructed to seek medical assistance immediately if they suspect they are experiencing an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data is currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted. Some forms of nickel have also been associated with carcinogenicity (ability to cause cancer) in animal models. In humans, carcinogenicity has been demonstrated only through an inhalation route (breathing nickel in) which will not occur with this procedure.
  • 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 device.

Post-implant

  • Endocarditis prophylaxis is carried out for 6 months according to the recommendation of the American Heart Association. The decision to continue endocarditis prophylaxis beyond 6 months is at the discretion of the physician.
  • Any patient who has a residual shunt will undergo an echo cardiographic evaluation of the residual shunt until complete closure of the defect has been confirmed.
  • Lung perfusion scan should be completed if flow through is greater than 3 m/s, or if the Z-score is -2 for the left pulmonary artery diameter.
  • MR Conditional to 3.0 Tesla
    Through nonclinical testing, the AMPLATZER™ device has been known to be MR Conditional at field strengths of 3.0 tesla or less with a maximum whole-body-averaged specific absorption rate (SAR) of 3.83 W/kg at 1.5 tesla and 5.57 W/kg at 5.0 tesla for a 20-minute exposure to a B1 of 118μ tesla. The AMPLATZER™ device should not migrate in this MR environment. Nonclinical testing has not been performed to rule out the possibility of migration at field strengths higher than 3.0 tesla.
    In this testing, the device produced a temperature rise of 1.1°C at 1.5 tesla and 1.6°C at 5.0 tesla.
    MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the device.

Use in Specific Populations

  • Pregnancy — Care should be taken to minimize the radiation exposure to the fetus and the mother.
  • Nursing mothers — There has been no quantitative assessment of the presence of leachables in breast milk.
POTENTIAL ADVERSE EVENTS

Placement of the AMPLATZER™ Duct Occluder involves using standard interventional cardiac catheterization techniques. In addition to the above observed adverse events, the following are potential adverse events listed in alphabetical order that were not observed in the clinical study.
The following events might occur from either the catheterization procedure or from the device:

Air embolus; Allergic dye reaction; Allergic drug reaction; Anesthesia reactions; Apnea; Arrhythmia; Bacterial endocarditis; Bleeding; Brachial plexus injury; Chest pain; Death; Delivery system failure; Fever; Headache/migraine; Hypertension; Hypotension; Myocardial infarction; Partial obstruction of aorta; Partial obstruction of pulmonary artery; Perforation of vessel or myocardium; Peripheral embolism; Stroke; Transient ischemic attack; Thrombus; Valvular regurgitation; Vascular access site complications.

 

AMPLATZER™ DUCT OCCLUDER II
INTENDED FOR USE

The AMPLAZTER™ Duct Occluder II is a percutaneous transcatheter occlusion intended for the non-surgical closure of patent ductus arteriosus.

CONTRAINDICATIONS

The AMPLATZER™ Duct Occluder II is contraindicated for the following:

  • Patients weighing less than 6 kg
  • Patients less than 6 months of age
  • Patients with a window-type patent ductus arteriosus (ie, length less than 3mm)
  • Patients with an active infection
  • Patients with thrombus at the intended site of implant
  • Patients with pulmonary hypertension with pulmonary vascular resistance of greater than 8 Wood units or Rp/Rs of greater than 0.4
  • Patients with patent ductus arteriosus greater than 12 mm in length by angiography
  • Patients with patent ductus arteriosus greater than 5.5 mm in diameter by angiography
WARNINGS
  • Patients at greater risk of complications can include:
    • Patients with descending aorta < 10 mm in diameter
    • Patients with cardiac anomalies requiring surgical or interventional correction
    • Patients with have had more than 2 lower respiratory infections within the last year
  • Do not release the occluder from the delivery wire if the occluder does not conform to its original configuration or if the occluder position is unstable. Recapture the occluder and redeploy. If still unsatisfactory, recapture the occluder and replace with a new occluder.
  • The AMPLATZER™ Duct Occluder II should only be used by physicians trained in transcatheter defect closure techniques.
  • Physicians must have an on-site surgeon available in the event the surgical removal of an occluder
    is required.
  • Embolized occluders must be removed. Embolized occluders should not be withdrawn through intracardiac structures unless they have been adequately collapsed within a catheter.
  • This device has not been studied in patients older than 18 years of age.
PRECAUTIONS
  • For single use only. Do not reuse or re-sterilize.
  • This device was sterilized with ethylene oxide and is for single use only. Do not use or re-sterilize this device. Attempts to re-sterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
  • Use before the expiration date noted on the product packaging.
  • Patients should have an activated clotting time (ACT) of greater than 200 sec prior to device replacement.
  • The AMPLATZER™ Duct Occluder II 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. 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 be instructed to seek medical assistance immediately if they suspect they are experiencing 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 – Care should be taken to minimize the radiation exposure to the fetus and the mother.
    • Nursing mothers – There has been no quantitative assessment of the presence of leachables in breast milk.
  • Store in a dry place.
  • Do not use if the packaging sterile barrier is opened or damaged.
  • Do not use contrast power injection with
    delivery catheter.
MR CONDITIONAL

St. Jude Medical’s AMPLATZER™ Duct Occluder II device is manufactured of chemically etched nitinol wire, 80% platinum 20% iridium marker band and a 316L end screw.
Non-clinical testing has demonstrated that the AMPLATZER™ Duct Occluder II device is MR-Conditional. Patients can be scanned safely immediately after implantation under the following conditions:

  • Static magnetic field of 1.5 Tesla (1.5T) or 3.0 Tesla (3.0T).
  • Maximum spatial gradient field less than or equal to 30 T/m.
  • Maximum whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for 15 minutes of scanning.

In non-clinical testing with body coil excitation, the AMPLATZER™ Duct Occluder II device produced a differential temperature rise of less than or equal to 3.65°C when exposed to a maximum average whole body specific absorption rate (SAR) of 3.35 W/kg for 15 minutes of scanning in a 3.0 Tesla MR system (Siemens™ MAGNETOM Espree™, SYNGO™ MR B17 software, Erlangen, Germany). Scaling of the SAR and observed heating indicates that average whole body SAR of 2.0 W/kg would be expected to yield a localized temperature rise of less than or equal to approximately 1.0°C in Normal Operating Mode.

In non-clinical testing with body coil excitation, the AMPLATZER™ Duct Occluder II device produced a differential temperature rise of less than or equal to 1.91°C when exposed to a maximum average whole body specific absorption rate (SAR) of 2.80 W/kg for 15 minutes of scanning in a 1.5 Tesla MR system (Siemens™ MAGNETOM Espree™, SYNGO™ MR B17 software, Erlangen, Germany). Scaling of the SAR and observed heating indicates that average whole body SAR of 2.0 W/kg would be expected to yield a localized temperature rise of less than or equal to approximately 1.0°C in Normal Operating Mode.

MR Image quality may be compromised if the area of interest is the same or relatively close to the
position of the device. Therefore, it may be necessary to optimize the MR imaging parameters for the presence of this implant.

POTENTIAL ADVERSE EVENTS

Potential adverse events that may occur during or after a procedure using this device may include,
but are not limited to:

Air embolus; Allergic dye reaction; Allergic drug reaction; Anesthesia reactions; Apnea; Arrhythmia; Bacterial endocarditis; Bleeding; Cardiac perforation; Cardiac tamponade; Chest pain; Device embolization; Device erosion; Death; Fever; Headache/migraine; Hypertension; Hypotension; Myocardial infarction; Palpitations; Pericardial effusion; Pericarditis; Peripheral embolism; Pleural effusion; Pulmonary embolism; Reintervention for device removal; Stroke; Transient ischemic attack; Thrombus; Valvular regurgitation; Vascular access site injury; and Vessel perforation.

 

AMPLAZTER PICCOLO™ OCCLUDER
INTENDED FOR USE

The AMPLAZTER Piccolo™ Occluder is a percutaneous transcatheter occlusion intended for the non-surgical 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 an on-site surgeon.
  • Accurate measurements of the ductus are crucial for correct occluder size selection.
  • 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.
  • 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 — Care should be taken to minimize the radiation exposure to the fetus and the mother.
  • Nursing mothers — There has been no quantitative assessment of the presence of leachables in breast milk.

Handling

  • Store in a dry place.
  • Do not use contrast power injection with delivery catheter.
POTENTIAL ADVERSE EVENTS

Potential adverse events that may occur during or after a procedure placing this device include, but are not limited to:

Air embolus; Allergic dye reaction; Allergic drug reaction; Anesthesia reactions; Apnea; Arrhythmia; Bacterial endocarditis; Bleeding; Cardiac perforation; Cardiac tamponade; Chest pain; Device embolization; Device erosion; Death; Fever; Headache/migraine; Hemolysis; Hematoma; Hypertension; Hypotension; Infection; Myocardial infarction; Palpitations; Partial obstruction of aorta; Partial obstruction of pulmonary artery; Pericardial effusion; Pericarditis; Peripheral embolism; Re-intervention for device removal; Respiratory distress; Stroke; Thrombus; Transient ischemic attack; Thrombus; Valvular regurgitation; Vascular access site injury; Vascular occlusion; Vessel perforation.