CONFIRM RX™

Model DM3500

Insertable Cardiac Monitor

INDICATIONS:

The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation. The Confirm Rx™ ICM has not been specifically tested for pediatric use.

CONTRAINDICATION:

There are no known contraindications for the insertion of the Confirm Rx™ ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.

ADVERSE EVENTS:

Possible adverse events (in alphabetical order) associated with the device, include the following: Allergic reaction, Bleeding, Chronic nerve damage, Erosion, Excessive fibrotic tissue growth, Extrusion, Formation of hematomas or cysts, Infection, Keloid formation and Migration. Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.

ADDITIONAL INFORMATION:

Clinicians must log onto Merlin.net™ Patient Care Network to view transmissions from patients’ Confirm Rx™ ICM. On Merlin.net™ PCN they can configure transmission schedules and enable or disable features on a patient’s myMerlin™ mobile app. Review of transmissions is dependent on the clinician and may not happen immediately following delivery of such transmissions.

LIMITATION:

Patients may use their own Apple‡ or Android‡ mobile device to transmit information from their Confirm Rx™ ICM using the myMerlin™ mobile app. To do so the device must be powered on, app must be installed, Bluetooth® wireless technology enabled and data coverage (cellular or WiFi‡) available. The myMerlin™ mobile app provides periodic patient monitoring based on clinician configured settings. Data is resent if the transmission was not sent successfully. However, there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of ICM and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, ICM memory capacity, clinic environment, schedule/configuration changes, or data processing.

An ��è mobile transmitter is available for patients without their own compatible mobile device.

BRIEF SUMMARY:

Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

INDICATION FOR USE:

The CardioMEMS™ HF System is indicated for wirelessly measuring and monitoring pulmonary artery (PA) pressure and heart rate in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year. The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations.

CONTRAINDICATIONS:

The CardioMEMS™ HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant.

POTENTIAL ADVERSE EVENTS:

Potential adverse events associated with the implantation procedure include, but are not limited to the following: Infection, Arrhythmias, Bleeding, Hematoma, Thrombus, Myocardial infarction, Transient ischemic attack, Stroke, Death, and Device embolization.

Refer to the Instructions for Use for detailed indications, contraindications, warnings, precautions and potential adverse events.

CAUTION:

This product is intended for use by or under the direction of a physician. Prior to use, reference Instructions for Use, inside the product carton (when available) or at eifu.abbottvascular.com or at manuals.sjm.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

INDICATIONS:

The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™ Module to combine and display magnetic processed patient positioning and navigation mapping information. When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. OR, when used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

WARNINGS:

Refer to the ablation catheter labeling for a listing of adverse events related to the use of this device in conjunction with radio frequency ablation, as a part of the diagnosis and treatment of cardiac arrhythmias. For patient safety, any connections that directly connect the patient to the EnSite Precision Cardiac Mapping System must be routed through the appropriate module: EnSite Precision Link, Sensor Enabled™ NavLink, EnSite Precision Field Frame, ArrayLink, CathLink, SJM ECG Cable, RecordConnect, or GenConnect. When using the EnSite Precision Module full protection against the effects of cardiac defibrillator discharge and other leakage currents is dependent upon the use of appropriate cables. Refer to the ablation catheter labeling for a listing of adverse events related to the use of this device in conjunction with radio frequency ablation, as a part of the diagnosis and treatment of cardiac arrhythmias. For patient safety, any connections that directly connect the patient to the EnSite Precision Cardiac Mapping System must be routed through the appropriate module: EnSite Precision Link, Sensor Enabled™ NavLink, EnSite Precision Field Frame, ArrayLink, CathLink, SJM ECG Cable, RecordConnect, or GenConnect. When using the EnSite Precision Module full protection against the effects of cardiac defibrillator discharge and other leakage currents is dependent upon the use of appropriate cables.

PRECAUTIONS:

Do not operate the EnSite Precision Field Frame within 10 meters (m) of another operating Field Frame. Do not place the EnSite Precision Field Frame cable inside the measurement volume or wrap it around the Field Frame, as it may create a magnetic interference. Do not coil the EnSite Precision Field Frame cable. The cable carries enough electric current that a magnetic field will be created when the cable is placed in a circular formation. This magnetic field may disturb the Field Frame’s magnetic field. Do not place the EnSite Precision Link, Sensor Enabled™ within 1 m of the EnSite Precision Field Frame - Do not place tool cables within 30 millimeters (mm) of the EnSite Precision Field Frame cable. If placed this close—particularly if the cables are parallel to each other—the tool cable may become subject to electromagnetic interference. Metallic equipment used in close proximity to the magnetic field during the procedure, such as a sterile drape holder, may affect Sensor Enabled (SE) points and SE field scaling accuracy. Do not use the EnSite Precision Cardiac Mapping System in the presence of other magnetic fields. Do not drop the EnSite Precision Field Frame or subject it to impact. Physical damage to the Field Frame may alter the Field Frame’s factory calibration.

The XIENCE V®, XIENCE nano®, XIENCE PRIME®, XIENCE PRIME® LL, XIENCE Xpedition®, XIENCE Xpedition® SV and XIENCE Xpedition® LL , XIENCE Alpine®, and XIENCE SierraTM (XIENCE Family) of Everolimus Eluting Coronary Stents on the MULTI-LINK VISION® or MULTI-LINK MINI VISION® Delivery System

INDICATIONS

The XIENCE Sierra stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm. In addition, the XIENCE Sierra stent system is indicated for treating de novo chronic total coronary occlusions.

CONTRAINDICATIONS

The XIENCE Sierra stent system is contraindicated for use in:

• Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or the post-procedural antiplatelet regimen.
• Patients with hypersensitivity or contraindication to everolimus or structurally related compounds, or known hypersensitivity to stent components (cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers), or with contrast sensitivity.

WARNINGS

• It is not recommended to treat patients having a lesion that prevent complete inflation of an angioplasty balloon.
• Judicious patient selection is necessary because the use of this device carries the associated risk of stent thrombosis, vascular complications, and/or bleeding events.
• This product should not be used in patients who are not likely to comply with the recommended antiplatelet therapy.

PRECAUTIONS

• Ensure that the inner package sterile barrier has not been opened or damaged prior to use.
• Stent implantation should only be performed by physicians who have received appropriate training.
• Stent placement should be performed at hospitals where emergency coronary artery bypass graft surgery (CABG) is accessible.
• Subsequent restenosis may require repeat dilatation of the arterial segment containing the stent. Long-term outcomes following repeat dilatation of the stent are presently unknown.
• Care should be taken to control the guiding catheter tip during stent delivery, deployment and balloon withdrawal. Before withdrawing the stent delivery system, visually confirm complete balloon deflation by fluoroscopy to avoid guiding catheter movement into the vessel and subsequent arterial damage.
• When DES are used outside the specified Indications for Use, patient outcomes may differ from the results observed in the SPIRIT family of trials.
• Compared to use within the specified Indications for Use, the use of DES in patients and lesions outside of the labeled indications may have an increased risk of adverse events, including stent thrombosis, stent embolization, MI, or death.
• Orally administered everolimus combined with cyclosporine is associated with increased serum cholesterol and triglycerides levels.
• A patient’s exposure to drug and polymer is proportional to the number and total length of implanted stents. See Instructions for Use for current data on multiple stent implantation.
• Safety and effectiveness of the XIENCE Family of stents have not been established for subject populations with the following clinical settings:
• Patients with prior brachytherapy of the target lesion or the use of brachytherapy for treated site restenosis, patients in whom mechanical atherectomy devices or laser angioplasty catheters are used in conjunction with XIENCE Family stents, women who are pregnant or lactating, men intending to father children, pediatric patients, unresolved vessel thrombus at the lesion site, coronary artery reference vessel diameters < 2.25 mm or > 4.25 mm or lesion length > 32 mm, lesions located in saphenous vein grafts, unprotected left main coronary artery, ostial lesions, lesions located at a bifurcation or previously stented lesions, diffuse disease or poor flow (TIMI < 1) distal to the identified lesions, excessive tortuosity proximal to or within the lesion, recent Acute Myocardial Infarction (AMI) or evidence of thrombus in target vessel, multivessel disease, and in-stent restenosis.
• Everolimus has been shown to reduce the clearance of some prescription medications when administered orally along with cyclosporine (CsA). Formal drug interaction studies have not been performed with the XIENCE Family of stents because of limited systemic exposure to everolimus eluted from the stent.
• Everolimus is an immunosuppressive agent. Consideration should be given to patients taking other immunosuppressive agents or who are at risk for immune suppression.
• Oral everolimus use in renal transplant patients and advanced renal cell carcinoma patients was associated with increased serum cholesterol and triglycerides, which in some cases required treatment.
• Non-clinical testing has demonstrated that the XIENCE Sierra stent, in single and in overlapped configurations up to 71 mm in length, is MR Conditional. It can be scanned safely under the conditions in the Instructions for Use.
• The XIENCE Family of stents should be handled, placed, implanted, and removed according to the Instructions for Use.

POTENTIAL ADVERSE EVENTS

Adverse events (in alphabetical order) which may be associated with percutaneous coronary intervention treatment procedures and the use of a coronary stent in native coronary arteries include, but are not limited to, the following:

• Abrupt closure, hematoma, or hemorrhage, Acute myocardial infarction, Allergic reaction or hypersensitivity to latex, contrast agent, anesthesia, device materials (platinum, polymer, cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers), and drug reactions to everolimus, anticoagulation, or antiplatelet drugs, Arterial rupture, Arteriovenous fistula, Arrhythmias, atrial and ventricular, Bleeding complications, which may require transfusion, Cardiac tamponade, Coronary artery spasm, Coronary or stent embolism, Coronary or stent thrombosis, Death, Dissection of the coronary artery, Fever, Hypotension and/or hypertension, Ischemia (myocardial), Myocardial infarction (MI), Nausea and vomiting, Palpitations, Peripheral ischemia, Pseudoaneurysm, Renal Failure, Restenosis, Shock/pulmonary edema, Stroke/cerebrovascular accident (CVA), Total occlusion of coronary artery, Unstable or stable angina pectoris, Vascular access complications which may require vessel repair, Vessel dissection

The risks described below include, but are not limited to, the anticipated adverse events relevant for the cardiac population referenced in the contraindications, warnings, and precautions sections of the everolimus labels.

• Abdominal pain; Anemia; Angioedema; Constipation; Cough; Diarrhea; Dyslipidemia (including hyperlipidemia and hypercholesterolemia); Dyspnea; Edema (peripheral); Headache; Hyperglycemia; Hypertension; Hypokalemia; Elevations of serum creatinine; Infections: bacterial, viral, fungal, and protozoan infections (may include opportunistic infections); Lymphoma and skin cancer; Male infertility; Oral ulcerations; Nausea; Non-infectious pneumonitis; Pain; Proteinuria; Pyrexia; Rash; Thrombotic microangiopathy (TMA)/Thrombotic thrombocytopenic purpura (TTP)/Hemolytic uremic syndrome (HUS); Urinary tract infection; Upper respiratory tract infection; Vomiting
• Live vaccines should be avoided and close contact with those that have had live vaccines should be avoided. Fetal harm can occur when administered to a pregnant woman. There may be other potential adverse events that are unforeseen at this time.

INDICATION FOR USE

• The �Ѿ��ٰ����������™ NTR/XTR System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.
• The �Ѿ��ٰ����������™ NTR/XTR System, when used with maximally tolerated guideline-directed medical therapy (GDMT), is indicated for the treatment of symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation (MR; MR ≥ Grade III  per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) ≥ 20% and ≤ 50%, and a left ventricular end systolic dimension (LVESD) ≤ 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.

CONTRAINDICATIONS

The �Ѿ��ٰ����������™ NTR/XTR System is contraindicated in patients with the following conditions:

• Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen
• Active endocarditis of the mitral valve
• Rheumatic mitral valve disease
• Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus

WARNINGS

• DO NOT use �Ѿ��ٰ����������™ outside of the labeled indication.
• The �Ѿ��ٰ����������™ Implant should be implanted with sterile techniques using fluoroscopy and echocardiography (e.g., transesophageal [TEE] and transthoracic [TTE]) in a facility with on-site cardiac surgery and immediate access to a cardiac operating room.
• Read all instructions carefully.  Failure to follow these instructions, warnings and precautions may lead to device damage, user injury or patient injury. Use universal precautions for biohazards and sharps while handling the �Ѿ��ٰ����������™ System to avoid user injury.
• Use of the �Ѿ��ٰ����������™ should be restricted to those physicians trained to perform invasive endovascular and transseptal procedures and those trained in the proper use of the system.
• The Clip Delivery System is provided sterile and designed for single use only.  Cleaning, re-sterilization and / or reuse may result in infections, malfunction of the device or other serious injury or death.
• Use caution when treating patients with hemodynamic instability requiring inotropic support or mechanical heart assistance due to the increased risk of mortality in this patient population. The safety and effectiveness of �Ѿ��ٰ����������™ in these patients has not been evaluated.

PRECAUTIONS

• Note the product “Use by” date specified on the package.
• Inspect all product prior to use. Do not use if the package is open or damaged, or if product is damaged.
• Prohibitive Risk Primary (or degenerative) Mitral Regurgitation 
• Prohibitive risk is determined by the clinical judgment of a heart team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, due to the presence of one or more of the following documented surgical risk factors:
• 30-day STS predicted operative mortality risk score of 
• ≥8% for patients deemed likely to undergo mitral valve replacement or
• ≥6% for patients deemed likely to undergo mitral valve repair
• Porcelain aorta or extensively calcified ascending aorta.
• Frailty (assessed by in-person cardiac surgeon consultation).
• Hostile chest
• Severe liver disease / cirrhosis (MELD Score > 12)
• Severe pulmonary hypertension (systolic pulmonary artery pressure > 2/3 systemic pressure)
• Unusual extenuating circumstance, such as right ventricular dysfunction with severe tricuspid regurgitation, chemotherapy for malignancy, major bleeding diathesis, immobility, AIDS, severe dementia, high risk of aspiration, internal mammary artery(IMA) at high risk of injury, etc.
• Evaluable data regarding safety or effectiveness is not available for prohibitive risk DMR patients with an LVEF < 20% or an LVESD > 60 mm.  MitraClip® should be used only when criteria for clip suitability for DMR have been met.
• The heart team should include a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease and may also include appropriate physicians to assess the adequacy of heart failure treatment and valvular anatomy.
• Secondary Mitral Regurgitation 
• Evaluable data regarding safety or effectiveness is not available for secondary MR patients with an LVEF < 20% or an LVESD > 70 mm.
• The multidisciplinary heart team should be experienced in the evaluation and treatment of heart failure and mitral valve disease and determine that symptoms and MR severity persist despite maximally tolerated GDMT.

POTENTIAL COMPLICATIONS AND ADVERSE EVENTS

The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClipTM procedure.

Death; Allergic reaction (anesthetic, contrast, Heparin, nickel alloy, latex); Aneurysm or pseudo-aneurysm; Arrhythmias; Atrial fibrillation; Atrial septal defect requiring intervention; Arterio-venous fistula; Bleeding;

Cardiac arrest; Cardiac perforation; Cardiac tamponade / Pericardial Effusion; Chordal entanglement / rupture; Coagulopathy; Conversion to standard valve surgery; Deep venous thrombus (DVT); Dislodgement of previously implanted devices; Dizziness; Drug reaction to anti-platelet / anticoagulation agents / contrast

media; Dyskinesia; Dyspnea; Edema; Emboli (air, thrombus, MitraClipTM Implant); Emergency cardiac surgery; Endocarditis; Esophageal irritation; Esophageal perforation or stricture; Failure to deliver MitraClipTM to the intended site; Failure to retrieve MitraClipTM System components; Fever or hyperthermia; Gastrointestinal bleeding or infarct; Hematoma; Hemolysis; Hemorrhage requiring transfusion; Hypotension / hypertension; Infection; Injury to mitral valve complicating or preventing later surgical repair; Lymphatic complications; Mesenteric ischemia; MitraClipTM Implant erosion, migration or malposition; MitraClipTM Implant thrombosis; MitraClipTM System component(s) embolization; Mitral stenosis; Mitral valve injury; Multi-system organ failure; Myocardial infarction; Nausea / vomiting; Pain; Peripheral ischemia; Prolonged angina; Prolonged ventilation; Pulmonary congestion; Pulmonary thrombo-embolism; Renal insufficiency or failure; Respiratory failure / atelectasis / pneumonia; Septicemia; Shock, Anaphylactic or Cardiogenic; Single leaflet device attachment (SLDA); Skin injury or tissue changes due to exposure to ionizing radiation; Stroke or transient ischemic attack (TIA); Urinary tract infection; Vascular trauma, dissection or occlusion; Vessel spasm; Vessel perforation or laceration; Worsening heart failure; Worsening mitral regurgitation; Wound dehiscence

INDICATIONS AND USAGE

The AMPLATZER™ 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 AMPLATZER™ 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 AMPLATZER™ PFOccluder has not been established in patients (with):
• Age less than 18 years or greater than 60 years because enrollment in the pivotal study (the RESPECT trial) was limited tpatients 18 t60 years old
• 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
• Unable ttake antiplatelet therapy
• Atherosclerosis or other arteriopathy of the intracranial and extracranial vessels associated with a ≥50% luminal stenosis
• Acute or recent (within 6 months) myocardial infarction or unstable angina
• Left ventricular aneurysm or akinesis
• Mitral valve stenosis or severe mitral regurgitation irrespective of etiology
• Aortic valve stenosis (mean gradient greater than 40 mmHg) or severe aortic valve regurgitation
• Mitral or aortic valve vegetation or prosthesis
• Aortic arch plaques protruding greater than 4 mm intthe aortic lumen
• Left ventricular dilated cardiomyopathy with left ventricular ejection fraction (LVEF) less than 35%
• Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter
• Uncontrolled hypertension or uncontrolled diabetes mellitus
• Diagnosis of lacunar infarct probably due tintrinsic small vessel as qualifying stroke event
• Arterial dissection as cause of stroke
• Index stroke of poor outcome (modified Rankin score greater than 3)
• Pregnancy at the time of implant
• 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. Dnot reuse or re-sterilize this device. Attempts tre-sterilize this device can cause a malfunction, insufficient sterilization, or harm tthe patient.
• The AMPLATZER™ PFOccluder device consists of a nickel-titanium alloy, which is generally considered safe. However, in vitrtesting has demonstrated that nickel is released from this device for a minimum of 60 days. Patients whare allergic tnickel may have an allergic reaction tthis device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed tnotify 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 alsdevelop an allergy tnickel if this device is implanted.
• Store in a dry place.
• Pregnancy – Minimize radiation exposure tthe fetus and the mother.
• Nursing mothers – There has been nquantitative 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. 

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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. 

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• 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: 
  • The valve has been dropped, damaged, or mishandled in anyway.
  • The expiration date has elapsed.
  • 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

• 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 h