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Indications for Use

The SJM™��Masters Series Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic or mitral heart valve. This device may also be used to replace a previously implanted mitral or aortic prosthetic valve.

Contraindications

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

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, prosthetic failure, failure or death. Any of these complications may require reoperation or explanation of the device.

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The Amplatzer Piccolo™ 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.

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 reaction, Anemia, Anesthesia reactions, Apnea, Arrhythmia, Bleeding, Cardiac perforation, Cardiac tamponade, Chest pain, Device embolization, Device erosion, Death, Endocarditis, 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.

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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.

Indications:��The HeartMate 3 Left Ventricular Assist System is indicated for providing short- and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in adult and pediatric patients with advanced refractory left ventricular heart failure and with an appropriate body surface area.

Contraindications:��The HeartMate 3 Left Ventricular Assist System is contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.

Adverse Events:��Adverse events that may be associated with the use of the HeartMate 3™ Left Ventricular Assist System are: death, bleeding, cardiac arrhythmia, localized infection, right heart failure, respiratory failure, device malfunctions, driveline infection, renal dysfunction, sepsis, stroke, other neurological event (not stroke-related), hepatic dysfunction, psychiatric episode, venous thromboembolism, hypertension, arterial non-central nervous system (CNS) thromboembolism, pericardial fluid collection, pump pocket or pseudo pocket infection, myocardial infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) or pump thrombosis.

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Indication 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.

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; Stroke; Tissue erosion; Thrombus formation on discs; Valvular regurgitation.

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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.

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Intended Use:��The Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are primarily intended for use with compatible leads detect and treat life threatening ventricular arrhythmias by providing ventricular antitachycardia pacing and ventricular cardioversion/defibrillation. In addition, these devices can detect and treat: chronic symptomatic bradyarrhythmia by providing sensing and pacing in the right ventricle; various atrioventricular conduction abnormalities by providing sensing and pacing in the right ventricle and/or right atrium. CRT-D devices sense cardiac activity and provide pacing to resynchronize the right and left ventricles.����

The myMerlinPulse™ mobile application is intended for use by people who have an ��«����Ƶ Medical implanted heart device and access to a mobile device. The app provides remote monitoring capability of the implanted heart device by transmitting information from the patient’s implanted heart device to the patient’s healthcare provider.

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Indications:��The ICD devices are indicated in patients who have already survived a cardiac arrest or are at a high risk of Sudden Cardiac Death (SCD) due to VT (ventricular tachycardia) or VF (ventricular fibrillation). Cardiac Resynchronization Therapy (CRT) devices are indicated for reduction of symptoms in patients who have congestive heart failure, a reduced left ventricular ejection fraction (LVEF) and a prolonged QRS duration. CRT-D devices are indicated in patients who meet the CRT indications and have already survived a cardiac arrest or are at a high risk of Sudden Cardiac Death (SCD) due to VT (ventricular tachycardia) or VF (ventricular fibrillation). The device is most commonly implanted within a device pocket in the pectoral region.��

The myMerlinPulse™ mobile application is indicated for use by patients with supported ��«����Ƶ Medical implanted heart devices.

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Contraindications:��Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction.��

The myMerlinPulse™ mobile application is contraindicated for use with any implanted medical device other than supported ��«����Ƶ Medical implanted heart devices.

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Adverse Events:��Possible adverse events associated with the implantation of the pulse generator system include the following: Arrhythmia (for example, accelerated or induced), Bradycardia, Cardiac or venous perforation, Cardiac tamponade, Cardiogenic shock, Death, Discomfort, Embolism, Endocarditis, Erosion, Exacerbation of heart failure, Excessive fibrotic tissue growth, Extracardiac stimulation (phrenic nerve, diaphragm, pectoral muscle), Extrusion, Fluid accumulation within the device pocket, Formation of hematomas, cysts, or seromas, Heart block, Hemorrhage, Hemothorax, Hypersensitivity, including local tissue reaction or allergic reaction, Infection, Keloid formation, Myocardial damage, Nerve damage, Occlusion/Thrombus, Pericardial effusion, Pericarditis, Pneumothorax, Pulmonary edema, Syncope, Thrombosis, Valve damage. Complications reported with direct subclavian venipuncture include pneumothorax, hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation of other vessels, massive hemorrhage and rarely, death. Among the psychological effects of device implantation are imagined pulsing, depression, dependency, fear of premature battery depletion, device malfunction, inappropriate pulsing, shocking while conscious, or losing pulse capability. Possible adverse device effects include complications due to the following: Abnormal battery depletion, Conductor fracture, Device-programmer communication failure, Elevated or rise in defibrillation/cardioversion threshold, Inability to defibrillate or pace, Inability to interrogate or program due to programmer or device malfunction, Incomplete lead connection with pulse generator, Inhibited therapy including defibrillation and pacing, Inappropriate therapy (for example, shocks and antitachycardia pacing [ATP] where applicable, pacing), Interruption of function due to electrical or magnetic interference, Intolerance to high rate pacing (for example dyspnea or discomfort), Lead abrasion, Lead fracture, Lead insulation damage, Lead migration or lead dislodgement, Loss of device functionality due to component failure, Pulse generator migration, Rise in DFT threshold, Rise in pacing threshold and exit block, Shunting of energy from defibrillation paddles, System failure due to ionizing radiation. Additionally, potential adverse events associated with the implantation of a coronary venous lead system include the following: Allergic reaction to contrast media, Breakage or failure of implant instruments, Prolonged exposure to fluoroscopic radiation, Renal failure from contrast media used to visualize coronary veins.����

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No potential adverse events have been identified with use of the myMerlinPulse™ mobile application.

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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.

Indications:��The AVEIR™ Leadless Pacemaker system is indicated for management of one or more of the following permanent conditions: Syncope, Pre-syncope, Fatigue, Disorientation. Rate-modulated pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-chamber pacing is indicated for patients exhibiting: Sick sinus syndrome, Chronic, symptomatic second- and third-degree AV block, Recurrent Adams-Stokes syndrome, Symptomatic bilateral bundle-branch block when tachyarrhythmia and other causes have been ruled out. Atrial pacing is indicated for patients with: Sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular pacing is indicated for patients with: Significant bradycardia and normal sinus rhythm with only rare episodes of AV block or sinus arrest, Chronic atrial fibrillation, Severe physical disability. MR Conditional: The AVEIR Leadless Pacemaker is conditionally safe for use in the MRI environment and according to the instructions in the MRI-Ready Leadless System Manual.

Intended Use:��The AVEIR Leadless Pacemaker (LP) is designed to provide bradycardia pacing as a pulse generator with built-in battery and electrodes for implantation in the right ventricle and/or right atrium. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy within the implanted chamber for the target treatment group. The LP is also intended to operate optionally with another co-implanted LP to provide dual-chamber pacing therapy.

The AVEIR™ Delivery Catheter is intended to be used in the peripheral vasculature and the cardiovascular system to deliver and manipulate an LP. Delivery and manipulation includes implanting an LP within the target chamber of the heart.

Contraindications:��Use of the AVEIR Leadless Pacemaker is contraindicated in these cases:

Use of any pacemaker is contraindicated in patients with a co-implanted ICD because high-voltage shocks could damage the pacemaker and the pacemaker could reduce shock effectiveness.

Single-chamber ventricular demand pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing.

Programming of rate-responsive pacing is contraindicated in patients with intolerance of high sensor driven rates.

Use is contraindicated in patients with an implanted vena cava filter or mechanical tricuspid valve because of interference between these devices and the delivery system during implantation.

Persons with known history of allergies to any of the components of this device may suffer an allergic reaction to this device. Prior to use on the patient, the patient should be counseled on the materials (listed in the Product Materials section of the IFU) contained in the device and a thorough history of allergies must be discussed.

Adverse Events:��Potential complications associated with the use of the AVEIR Leadless Pacemaker system are the same as with the use of single or dual chamber pacemakers with active fixation pacing leads including, but not limited to: Cardiac perforation, Cardiac tamponade, Pericardial effusion, Pericarditis, Endocarditis, Valve damage or regurgitation, Heart failure, Pneumothorax/hemothorax, Cardiac arrhythmias, Diaphragmatic/phrenic nerve stimulation / extra-cardiac stimulation, Palpitations, Hypotension, Syncope, Cerebrovascular accident, Infection, Hypersensitivity reaction to device materials, contrast media, medications, or direct toxic effect of contrast media on kidney function, Pacemaker syndrome, Inability to interrogate or program the LP due to programmer or LP malfunction, Intermittent or complete loss of capture, pacing or sensing (non-battery related), Oversensing, Increased capture threshold, Inappropriate sensor response, Corrupted, intermittent, or loss of i2i communications, Interruption of desired LP function due to electrical interference, either electromyogenic or electromagnetic, Battery malfunction/ premature battery depletion, Device-related complications (Premature deployment, Device dislodgement/embolization of foreign material, Inability to release/re-dock of the LP from the catheter, Helix distortion), Additional surgery or intervention, Death. As with any percutaneous catheterization procedure, potential complications include, but are not limited to: Vascular access complications; such as perforation, dissection, puncture, groin pain, Bleeding or hematoma, Thrombus formation, Thromboembolism, Air embolism, Local and systemic infection, Peripheral nerve damage. General surgery risks and complications from comorbidities; such as dyspnea, respiratory failure, pneumonia, hypertension, cardiac failure, reaction to sedation, renal failure, anemia, and death.