AMPLATZER PICCOLO OCCLUDER

INDICATIONS AND USAGE

The AMPLATZER PiccoloTM 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 PiccoloTM 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

n Pregnancy — Minimize radiation exposure to the

fetus and the mother.

n 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.

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

INDICATIONS AND USAGE

The AMPLATZERTM PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between

the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism,

as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.

CONTRAINDICATIONS

• Patients with intra-cardiac mass, vegetation, tumor or thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the PFO is gained.

• Patients whose vasculature, through which access to the PFO is gained, is inadequate to accommodate the appropriate sheath size.

• Patients with anatomy in which the AMPLATZERTM PFO device size required would interfere with other intracardiac or intravascular structures, such as valves or pulmonary veins.

• Patients with other source of right-to-left shunts, including an atrial septal defect and/or fenestrated septum.

• Patients with active endocarditis or other untreated infections.

WARNINGS

• Patients who are at increased risk for venous thromboembolic events should be managed with thromboembolic risk reduction regimen after the PFO Closure following standard of care.

• Do not use this device if the sterile package is open or damaged.

• Prepare for situations that require percutaneous or surgical removal of this device. This includes availability of a surgeon.

• Embolized devices must be removed as they may disrupt critical cardiac functions. Do not remove an embolized occluder through intracardiac structures unless the occluder is fully recaptured inside a catheter or sheath.

• Patients who are allergic to nickel can have an allergic reaction to this device.

• This device should be used only by physicians who are trained in standard transcatheter techniques.

• Transient hemodynamic compromise may be encountered during device placement, which may require fluid replacement or other medications as determined by the physician.

• Do not release the device 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)). If the device interferes with an adjacent cardiac structure, 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.

• Ensure there is sufficient distance from the PFO to the aortic root or SVC (typically defined as 9 mm or greater as measured by echo). See Figure 6. and Figure 7.

PRECAUTIONS

• The safety and effectiveness of the AMPLATZERTM PFO Occluder has not been established in

patients (with):

n Age less than 18 years or greater than 60 years because enrollment in the pivotal study (the RESPECT trial) was limited to patients 18 to 60 years old

n A hypercoagulable state including those with a positive test for a anticardiolipin antibody (IgG or IgM), Lupus anticoagulant, beta-2 glycoprotein-1 antibodies, or persistently elevated fasting plasma homocysteine despite medical therapy

n Unable to take antiplatelet therapy

n Atherosclerosis or other arteriopathy of the

intracranial and extracranial vessels associated with a ≥50% luminal stenosis

n Acute or recent (within 6 months) myocardial infarction or unstable angina

n Left ventricular aneurysm or akinesis

n Mitralvalvestenosisorseveremitralregurgita-

tion irrespective of etiology

n Aortic valve stenosis (mean gradient greater than 40 mmHg) or severe aortic valve regurgitation

n Mitral or aortic valve vegetation or prosthesis n Aortic arch plaques protruding greater than 4

mm into the aortic lumen

n Left ventricular dilated cardiomyopathy with left ventricular ejection fraction (LVEF) less than 35%

n Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter

n Uncontrolled hypertension or uncontrolled diabetes mellitus

n Diagnosis of lacunar infarct probably due to intrinsic small vessel as qualifying stroke event

n Arterial dissection as cause of stroke

n Index stroke of poor outcome (modified Rankin

score greater than 3)

n Pregnancy at the time of implant n Multi-organ failure

• Use on or before the last day of the expiration month that is printed on the product packaging label.

• This device was sterilized with ethylene oxide and is for single use only. Do not reuse or re-sterilize this device. Attempts to re-sterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.

• The AMPLATZERTM PFO Occluder device consists of a 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 notify their physicians immediately if they suspect they are experiencing an allergic reaction such as difficulty breathing or inflammation of the face or throat. Some patients may also develop an allergy to nickel if this device is implanted.

• Store in a dry place.

• 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.

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 drug reaction; Allergic dye reaction; Allergic metal reaction: Nitinol (nickel, titanium), platinum/iridium, stainless steel (chromium, iron, manganese, molybdenum, nickel); Anesthesia reactions; Apnea; Arrhythmia; Bacterial

endocarditis; Bleeding ; Brachial plexus injury; Cardiac perforation; Cardiac tamponade; Cardiac thrombus; Chest pain; Device embolization; Device erosion; Deep vein thrombosis; Death; Endocarditis; Esophagus injury; Fever; Headache/migraine; Hypertension/hypotension; Myocardial infarction; Pacemaker placement secondary to PFO device closure; Palpitations; Pericardial effusion; Pericardial tamponade; Pericarditis; Peripheral embolism; Pleural effusion; Pulmonary embolism; Reintervention for residual shunt/device removal; Sepsis; Stroke; Transient ischemic attack; Thrombus; Valvular regurgitation; Vascular access site injury;

Vessel perforation

INDICATIONS FOR USE

The SJMTM Masters Series Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning mitral or aortic heart valve. This device

may also be used to replace a previously implanted mitral or aortic prosthetic heart valve.

The sizer model 905-15 is indicated to confirm size selection of the 15AHPJ-505 and 15MHPJ-505 valves.

CONTRAINDICATIONS

The SJMTM Masters Series Mechanical Heart Valve is contraindicated for individuals unable to tolerate anticoagulation therapy.

The sizer model 905-15 is contraindicated for use with any devices other than the 15 AHPJ-505 and 15MHPJ-505 valves. Any sizer sterilization method other than steam is contraindicated.

WARNINGS

Valve

• For single use only. Attempts to reuse the valve may result in valve malfunction, inadequate sterilization, or patient harm.

• Use only St. Jude MedicalTM mechanical heart valve sizers.

• Do not use if:

n The valve has been dropped, damaged, or

mishandled in anyway.

n The expiration date has elapsed.

n The tamper-evident container seal or inner/ outer tray seals are damaged, broken, or missing.

• Remove any residual tissue that may impair valve size selection, correct seating of the valve, rotation of the valve, or leaflet motion.

• Proper valve size selection is crucial. Do

not oversize the valve. If the native annulus measurement falls between two SJMTM Masters Series Mechanical Heart Valve sizes, use the smaller prosthetic valve size.

• The outer tray is not sterile, and should not be placed in the sterile field.

• To minimize direct handling of the valve during implantation, do not remove the holder/rotator until the valve has been seated in the annulus.

• Do not use hard or rigid instruments to test leaflet mobility, as this may result in structural damage to the valve or thromboembolic complications. Use a St. Jude MedicalTM leaflet tester to gently test valve leaflet mobility.

• Place sutures in the outer half of the valve sewing cuff.

• Never apply force to the valve leaflets. Force may cause structural damage to the valve.

• Use only SJMTM Valve Holder/Rotators to perform valve rotation. Use of other instruments could result in structural damage. The valve holder/rotator is intended for single use only and should be discarded after surgery.

• The two retention sutures on the valve holder/ rotator must be cut and removed before the valve can be rotated.

• Do not pass catheters or other instruments through St. Jude MedicalTM mechanical heart valves. This could result in scratched or damaged valve components, leaflet fracture, or dislodgment.

• Cut suture ends short, especially in the vicinity of the pivot guards, to prevent leaflet impingement.

PRECAUTIONS

Valve

• Do not touch the prosthetic valve unnecessarily, even with gloved hands. This may cause scratches or surface imperfections that may lead to thrombus formation.

• Be careful not to cut or tear the valve sewing cuff when removing the identification tag and the holder/rotator from the valve.

• Before placing sutures in the valve sewing cuff, verify that the valve is mounted correctly on the valve holder/rotator.

• To avoid structural damage, the valve must be rotated in the fully open position.

• To minimize rotational torque, verify that the valve holder/rotator is properly seated in the valve, and that the valve holder handle is perpendicular to the valve.

• Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.

• Implantation of a prosthetic valve too large

for the annulus may result in increased risk of damage to the conductive system, obstruction of the left ventricular outflow tract, impairment of valve mobility, damage to the left circumflex artery, and damage to surrounding tissues or cardiac structures including obstruction and/or distortion of adjacent cardiac structures.

• NOTE: PROSPECTIVE DATA TO SUPPORT SAFETY AND EFFECTIVENESS OF THE 15-mm HP VALVE IMPLANTED IN THE AORTIC POSITION ARE NOT CURRENTLY AVAILABLE.

Sizer

• Instruments must be cleaned and sterilized prior to use.

• Do not use cracked, deformed, discolored/rusted, or damaged instruments.

• Improper cleaning may result in an immunological or toxic reaction.

• Instrument sterilization temperature must not exceed 280°F (138°C).

• Do not bend flexible instrument handles beyond a 90° angle.

• Instruments must be sterilized in a tray or container that is permeable to steam.

• Do not expose instruments to cleaning or rinse agents that are not compatible with polysulfone or polyphenylsulfone.

POTENTIAL ADVERSE EVENTS

Complications associated with replacement mechanical heart valves include, but are not limited to, hemolysis, infections, thrombus, or thromboembolism, valve dehiscence, unacceptable hemodynamic performance, hemorrhagic complications secondary to anticoagulation therapy, heart block requiring pacemaker implant, prosthetic failure, adjacent cardiac structure interference, heart failure, stroke, myocardial infarction, or death. Any of these complications may require reoperation or explantation of the device.