Structural Interventions

Indications and Usage
The AMPLATZER™ 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™ 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 Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within a sheath.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.

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
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.
 

Indications and Usage
The AMPLATZER™ Muscular VSD Occluder is indicated for use in patients with a complex ventricular septal defect (VSD) of significant size to warrant closure (large volume left-to right shunt, pulmonary hypertension, and/or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition.
High-risk anatomical factors for transatrial or transarterial surgical closure include patients:

• Requiring left ventriculotomy or an extensive right ventriculotomy.
• With a failed previous VSD closure.
• With multiple apical and/or anterior muscular VSDs (“Swiss cheese septum”).
• With posterior apical VSDs covered by trabeculae.

Contraindications
The AMPLATZER™ Muscular VSD Occluder is contraindicated for the following:

• Patients with defects less than 4 mm distance from the semilunar (aortic and pulmonary) and atrioventricular valves (mitral and tricuspid)
• Patients with severely increased pulmonary vascular resistance above 7 Wood units and a right-to-left shunt and documented irreversible pulmonary vascular disease
• Patients with perimembranous (close to the aortic valve) VSD
• Patients with post-infarction VSD
• Patients who weigh less than 5.2 kg. (Patients smaller than 5.2 kg were studied in the clinical trial, but due to poor outcome, these patients have been contraindicated for device placement. Data from these patients has not been included in the overall analysis.)
• Patients with sepsis (local/generalized)
• Patients with active bacterial infections
• Patients with contraindications to antiplatelet therapy or agents

Warnings

• The AMPLATZER™ Muscular VSD Occluder and delivery system should only be used by those physicians trained in transcatheter defect closure techniques.
• Physicians must be prepared to deal with urgent situations, such as device embolization, which require removal of the device. 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.
• Use on or before the last day of the expiration month noted on the product packaging.
• The device is sterilized using ethylene oxide and is for single use only. Do not reuse or resterilize. Attempts to resterilize the device may result in device malfunction, inadequate sterilization, or patient harm.
• Do not use the device if the packaging sterile barrier is open or damaged.
• Do not release the AMPLATZER™ Muscular VSD 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.
• Device closure in patients who have suffered a previous thromboembolic stroke should be discussed with the patient or family. In addition, consultation with a neurologist and hematologist is suggested to determine if the benefit of device closure outweighs the risk.

Precautions
Handling
Store in a dry place.

Sizing
Accurate defect sizing is crucial and mandatory for AMPLATZER™ Muscular VSD Occluder device selection. The VSD should be assessed and sized at end diastole by transesophogeal echocardiography (TEE) or angiography to determine the appropriate device size. Device selection should be 2 mm larger than the defect size.

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.
• 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.
• This device should only be used by physicians who have been trained in transcatheter techniques and who should determine which patients are suitable candidates for procedures using this device.
• Aspirin (eg, 81 mg or 325 mg) or an alternative antiplatelet/anticoagulant is recommended to be started at least 24 hours prior to the procedure. Cephalosporin therapy is optional.
• Maintain a recommended minimum active clotting time (ACT) of 200 seconds prior to device insertion and throughout the procedure.
• If TEE is used, the patient's esophogeal anatomy must be adequate for placement and manipulation of the TEE probe.
• Patients requiring multiple devices and/or concomitant catheterization procedures might require prolonged fluoroscopy times and multiple cineangiograms. The risks of radiation exposure (eg, increased cancer risk) should be discussed in detail with the patient or family and alternatives which do not involve radiation exposure should be reviewed.

Post-implant

• Patients should be treated with antiplatelet/anticoagulation therapy (such as aspirin) for 6 months post-implant. The decision to continue antiplatelet/anticoagulation therapy beyond 6 months is at the discretion of the physician.
• Endocarditis prophylaxis should be followed according to the American Heart Association recommendations.
• Any patient who has a residual shunt should undergo an echocardiographic evaluation of the residual shunt every 6 months until complete closure of the defect has been confirmed.
• Patients should be instructed to avoid strenuous activity for 1 month. Strenuous activities such as contact sports prior to 1 month after implant may cause the device to dislodge and embolize.

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 from the device/procedure in breast milk, and the risk to nursing mothers is unknown.

MR Conditional1
Through non-clinical testing, AMPLATZER™ devices have been shown to be MR Conditional. A patient with an implanted AMPLATZER™ device can be scanned safely immediately after placement of the device under the following conditions:

• Static magnetic field of 3 tesla or less
• Spatial gradient magnetic field of 720 G/cm or less
• Maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning

During testing, the device produced a clinically non-significant temperature rise at a maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scanning in a 3-tesla MR system using a transmit/receive body coil.
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. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.
1. MR Conditional as defined in ASTM F 2503-05.

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

• Air embolus
• Allergic drug reaction
• Allergic dye reaction
• Anemia
• Anesthesia reactions
• Apnea
• Arrhythmia
• Arterial pulse loss
• Atelectasis
• Bacterial endocarditis
• Blood loss requiring transfusion
• Brachial plexus injury
• Cardiac arrest
• Cardiomyopathy
• Chest pain
• Cyanosis
• Death
• Device embolization
• Device fracture
• Fever
• Headache/migraine
• Heart block
• Hypotension
• Myocardial infarction
• Perforation of the vessel or myocardium
• Peripheral embolism
• Stridor
• Stroke
• Subaortic stenosis
• Thrombus formation on device
• Vascular access site injury
• Venous thrombosis
• Vomiting
   

Indications for Use

The AMPLATZER™ Septal Occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the occlusion of atrial septal defects (ASD) in secundum position or patients who have undergone a fenestrated Fontan procedure and who now require closure of the fenestration. Patients indicated for ASD closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (such as, 1.5:1 degree of left-to-right shunt or RV enlargement).

Contraindications

The AMPLATZER™ Septal Occluder is contraindicated for the following:

• Any patient known to have extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery.
• Any patient known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement.
• Any patient known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy, unless another antiplatelet agent can be administered for 6 months.
• Any patient known to have a demonstrated intracardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).
• Any patient whose size (such as, too small for transesophageal echocardiography probe, catheter size) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization.
• Any patient where the margins of the defect are less than 5 mm to the coronary sinus, inferior vena cava rim, AV valves, or right upper lobe pulmonary vein.

Warnings

• Physicians must be prepared to deal with urgent situations, such as device embolization, which require removal of the device. This includes the availability of an on-site surgeon.
• Embolized devices must be removed as they may disrupt critical cardiac functions. Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within the sheath.
• Use on or before the expiration date noted on the product packaging.
• This device is sterilized using ethylene oxide and is for single use only. Do not reuse or resterilize. Attempts to resterilize the device may result in device malfunction, inadequate sterilization, or patient harm.
• Do not use the device if the packaging sterile barrier is open or damaged.
• Do not release the AMPLATZER™ Septal Occluder from the delivery cable if the device does not conform to its original configuration, or if the device position is unstable or if the device interferes with any adjacent cardiac structure (such as Superior Vena Cava (SVC), Pulmonary Vein (PV), Mitral Valve (MV), Coronary Sinus (CS), aorta (AO)). Recapture the device and redeploy. If still unsatisfactory, recapture the device and either replace with a new device or refer the patient for alternative treatment.
• Implantation of this device may not supplant the need for Coumadin‡ in patients with ASD and paradoxical emboli.
• The use of echocardiographic imaging (TTE, TEE, or ICE) is required.
• Balloon sizing should be used to size the atrial septal defect using a stop-flow technique. Do not inflate the balloon beyond the cessation of the shunt (such as, stop-flow). DO NOT OVERINFLATE.
• Patients with a retro-aortic rim of less than 5 mm in any echocardiographic plane, or patients in whom the device physically impinges on (i.e. indents or distorts) the aortic root, may be at increased risk of erosion.
• Do not select a device size greater than 1.5 times the echocardiographic-derived ASD diameter prior to balloon sizing.

Precautions

• The use of this device has not been studied in patients with patent foramen ovale.
• Use standard interventional cardiac catheterization techniques to place this device.
• Placement of the AMPLATZER™ Septal Occluder may impact future cardiac interventions, for example transeptal puncture and mitral valve repair.
• 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.

Handling
Store in a dry place.

Procedural

• This device should only be used by physicians who have been trained in transcatheter techniques and who should determine which patients are suitable candidates for procedures using 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 device.
• Aspirin (for example, 81 mg or 325 mg) or an alternative antiplatelet/anticoagulant is recommended to be started at least 24 hours prior to the procedure. Cephalosporin therapy is optional.
• Maintain a recommended minimum active clotting time (ACT) of 200 seconds prior to device insertion and throughout the procedure.
• If TEE is used, the patient's esophageal anatomy must be adequate for placement and manipulation of the TEE probe.

Post-implant

• Patients should take appropriate endocarditis prophylaxis for 6 months following device implantation. The decision to continue endocarditis prophylaxis beyond 6 months is at the discretion of the physician.
• Patients should be treated with antiplatelet/anticoagulation therapy (such as aspirin) for 6 months post-implant. The decision to continue antiplatelet/anticoagulation therapy beyond 6 months is at the discretion of the physician.
• Clinical follow-up with a cardiologist and echocardiograms are recommended at implant, 1 day post-implant, pre-discharge, and again at 1 week, 1 month, 6 months, and 12 months post-implant. Immediate follow-up with a cardiologist with the onset of any new symptoms suggestive of erosion or impending erosion, and routine clinical follow-up annually thereafter is also recommended.

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 from the device/procedure in breast milk, and the risk to nursing mothers is unknown.

MR Conditional to 3.0 Tesla
Caution should be used if an MRI is performed with a magnetic field of >3.0 tesla. Through non-clinical 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 118 μT. The AMPLATZER™ device should not migrate in this MR environment. Non-clinical 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.

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

• Air embolus
• Allergic dye reaction
• Anesthesia reactions
• Apnea
• Arrhythmia
• Cardiac tamponade
• Death
• Embolization
• Fever
• Hypertension/hypotension
• Infection including endocarditis
• Need for surgery
• Pericardial effusion
• Perforation of vessel or myocardium
• Pseudoaneurysm including blood loss requiring transfusion
• Tissue erosion
• Thrombus formation on discs
• Stroke
• Valvular regurgitation
   

Indication for Use: The Amplatzer™ Amulet™ Left Atrial Appendage Occluder is a percutaneous transcatheter device intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.

Contraindications: The Amplatzer™ Amulet™ Left Atrial Appendage (LAA) Occluder is contraindicated for patients:

• with the presence of intracardiac thrombus,
• with active endocarditis or other infections producing bacteremia.
• where placement of the device would interfere with any intracardiac or intravascular structures.
  
  

Warnings:

• If the device is retracted while it is in the sheath, the device and the sheath must both be removed and replaced. Failure to replace both the device and the sheath may result in sheath and/or device malfunction.
• If the device is retracted farther than the radiopaque markers (fully recaptured), the device and the sheath must both be removed and replaced. Failure to replace both the device and the sheath may result in sheath and/or device malfunction.
• Physicians must be prepared to deal with urgent situations, such as pericardial effusion or device embolization, which can require removal of the device.
• 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.
• Late pericardial effusion events were observed in the clinical study. The use of post-procedure anticoagulation therapy may be associated with an increased potential for a late pericardial effusion. Physicians should monitor for signs and symptoms of pericardial effusion and obtain appropriate imaging when indicated. Physicians should also consider routine echocardiography to screen for pericardial effusion.
• Remove embolized devices. Do not remove an embolized device unless the device is fully captured inside a sheath.
• The Amplatzer™ Amulet™ device contains a nickeltitanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 120 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.
• Do not use this device if the sterile package is open or damaged.
• The 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.
• Use on or before the expiration date that is printed on the product packaging label.
  
  

Precautions:

• The physician should exercise clinical judgment in situations that involve the use of antithrombotic drugs before, during, and/or after the use of this device.
• The physician should exercise caution if implanting a device in a patient who has an implantable cardioverter defibrillator (ICD) or pacemaker leads.
• The physician should have the guidewire in the left upper pulmonary vein when making exchanges in the left atrium.
• Ensure that the vasculature is adequate for the sheath size being selected.
• The physician should exercise caution if performing ablation at or near the implant site after the device is implanted.
• Use standard interventional cardiovascular catheterization techniques when using Amplatzer™ products.
• Use in specific populations
  • Pregnancy – Minimize the radiation exposure to the fetus and the mother.
  • Nursing mothers – There has been no quantitative assessment for the presence of leachables in breast milk.
    
    

MRI Safety Information: Non-clinical testing has demonstrated that the Amplatzer™ Amulet™ Left Atrial Appendage Occluder device is MR Conditional. A patient with the Amplatzer™Amulet™ device can be safely scanned in an MR system under the following conditions:

• Static magnetic fields of 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T)
• Maximum spatial gradient field of 19 T/m (1900 G/cm)
• Maximum MR system reported, whole-body averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode)

Under the scan conditions defined above, the device is expected to produce a maximum temperature rise of less than or equal to 4°C after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the device extends radially up to 20 mm from the device when imaged with a gradient echo pulse sequence in a 3.0T MR system.

Potential Adverse Events: Potential adverse events associated with the device or implant procedure include, but are not limited to, the following:

• Air embolism
• Airway trauma
• Allergic reaction
• Anemia
• Anesthesia reaction (nausea, vasovagal reaction, confusion/altered mental status or other)
• Arrhythmia
• Atrial septal defect
• Bleeding
• Cardiac arrest
• Cardiac tamponade
• Chest pain/discomfort
• Congestive heart failure
• Death
• Device embolization
• Device erosion
• Device malfunction
• Device malposition
• Device migration
• Device-related thrombus
• Fever
• Hematuria
• Hypertension/hypotension
• Infection
• Multi-organ failure
• Myocardial infarction
• Perforation
• Pericardial effusion
• Pleural effusion
• Renal failure/dysfunction
• Respiratory failure
• Seizure
• Significant residual flow
• Stroke
• Thrombocytopenia
• Thromboembolism: peripheral and pulmonary
• Thrombus formation
• Transient ischemic attack
• Valvular regurgitation/insufficiency
• Vascular access site injury (hematoma, pseudoaneurysm, arteriovenous fistula, groin pain or other)
• Vessel trauma/injury