AMPLATZER Patent Ductus Arteriosus

AMPLATZER^TM DUCT OCCLUDER AND DELIVERY SYSTEM
INDICATIONS AND USAGE

The AMPLATZER^TM Duct Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical 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^TM 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 Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within a sheath.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^TM 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^TM 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^TM 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^TM 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^TM 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 drug reaction
• Allergic dye 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^TM DUCT II OCCLUDER
INTENDED FOR USE

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

CONTRAINDICATIONS

The AMPLATZER^TM 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^TM 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^TM 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^TM 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^TM 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^TM 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^TM MAGNETOM Espree^TM, SYNGO^TM 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^TM 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^TM MAGNETOM Espree^TM, SYNGO^TM 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.

AMPLATZER PICCOLO^TM OCCLUDER
INDICATIONS AND USAGE

The AMPLATZER Piccolo^TM 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 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^TM 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.

MR CONDITIONAL

St. Jude Medical’s AMPLATZER^TM 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^TM 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^TM 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 2.80 W/kg for 15 minutes of scanning in a 1.5 Tesla MR system (Siemens^TM MAGNETOM Espree^TM, SYNGO^TM 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 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
• Pleural effusion
• Pulmonary embolism
• Re-intervention for device removal
• Respiratory distress
• Stroke
• Thrombus
• Transient ischemic attack
• Valvular regurgitation
• Vascular access site injury
• Vascular occlusion
• Vessel perforation