Amplatzer™ Muscular VSD Occluders

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 Embolized devices should not be withdrawn through intracardiac structures unless they have been adequately collapsed within a sheath.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™ Post-infarct Muscular VSD Occluder is a percutaneous transcatheter occlusion device intended for closure of post-myocardial infarct muscular VSDs in patients who are not satisfactory surgical candidates.
 

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

• Patients with perimembranous VSDs or a VSDs close to the aortic or mitral valve
• Patients with congenital muscular VSDs
• Patients with the 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
• Patients with 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 known to have active sepsis 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
   

Warnings

• The AMPLATZER™ Post-infarct Muscular VSD Occluder should only be used by 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
  • CAUTION: 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 the device if the packaging sterile barrier is open or damaged
• 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 release the AMPLATZER™ Post-infarct 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 it with a new device.
• ‬Remove the dilator and sheath from the patient slowly to prevent an ingress of air
   

Precautions

• 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 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; and therefore, 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.

Handling
Store in a dry place.

Procedural

• Use standard interventional cardiovascular catheterization techniques when using AMPLATZER™ products.
• This device should only be used by physicians who have been trained in transcatheter techniques. The physician 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 (3–5 mg/kg/day) is to be started at least 24 hours prior to the procedure. Cephalosporin therapy is optional.
• Transesophageal echocardiography (TEE) or similar imaging equipment is recommended as an aid in placing the device. If TEE is used, the patient's esophageal anatomy must be adequate for placement and manipulation of the TEE probe.

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.
   

MR Safety Information
Non-clinical testing has demonstrated the AMPLATZER™ Post-Infarct Muscular VSD Occluder is MR Conditional. A patient with this device can be safely scanned immediately after implantation in an MR system meeting the following conditions:

• Static magnetic field of 3T
• Maximum spatial field gradient of 720 gauss/cm
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)

Under the scan conditions defined above, the AMPLATZER™ Post-Infarct Muscular VSD Occluder is expected to produce a maximum temperature rise of less than 1.7ºC after 15 minutes of continuous scanning. In non-clinical testing, the image artifact caused by the device extends approximately 20 mm from the AMPLATZER™ Post-Infarct Muscular VSD Occluder when imaged with a gradient echo pulse sequence and a 3T MRI system.
 

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 reaction
• Anemia
• Anesthesia reaction
• Apnea
• Arrhythmia
• Arterial pulse loss
• Atelectasis
• Bacterial endocarditis
• Bleeding
• Brachial plexus injury
• Cardiac arrest
• Cardiomyopathy
• Cyanosis
• Chest pain
• Death
• Device embolization
• Device fracture
• Fever
• Headache/migraine
• Heart block
• Heart failure
• Hemolysis
• Hypertension
• Hypotension
• Left ventricular aneurysm
• Myocardial infarction
• Perforation of vessel or myocardium
• Peripheral embolism
• Renal insufficiency
• Respiratory arrest
• Sepsis
• Stridor
• Stroke/TIA
• Sub-aortic stenosis
• Thrombocytopenia
• Thrombus
• Valvular regurgitation/insufficiency
• Vascular access site complications
• Venous thrombosis
• Vomiting