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.

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

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 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.

IMPORTANT SAFETY INFORMATION
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

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

INDICATION FOR USE • The MitraClipTM G4 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 MitraClipTM G4 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 MitraClipTM G4 System is contraindicated in patients with the following conditions: • Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or post procedural anti-platelet regimen • Patients with known hypersensitivity to clip components (nickel / titanium, cobalt, chromium, polyester), or with contrast sensitivity • 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 MitraClipTM outside of the labeled indication. • The MitraClipTM G4 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. Use universal precautions for biohazards and sharps while handling the MitraClipTM G4 System to avoid user injury. Failure to follow these instructions, warnings and precautions may lead to device damage, user injury or patient injury including: n MitraClipTM G4 Implant erosion, migration or malposition n Failure to deliver MitraClipTM G4 Implant to the intended site n Difficulty or failure to retrieve MitraClipTM G4 system components • 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 MitraClipTM in these patients has not been evaluated. • Patients with a rotated heart due to prior cardiac surgery in whom the System is used may have a potential risk of experiencing adverse events such as atrial perforation, cardiac tamponade, tissue damage, and embolism which may be avoided with preoperative evaluation and proper device usage. • For the Steerable Guide Catheter and Delivery Catheter only: n The Guide Catheter: the distal 65 cm of the Steerable Guide Catheter with the exception of the distal soft tip, is coated with a hydrophilic coating. n The Delivery Catheter: coated with a hydrophilic coating for a length of approximately 131 cm. n Failure to prepare the device as stated in these instructions and failure to handle the device with care could lead to additional intervention or serious adverse event. • 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 and other serious injury or death. • 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. PRECAUTIONS • Prohibitive Risk Primary (or degenerative) Mitral Regurgitation n 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 4 ≥8% for patients deemed likely to undergo mitral valve replacement or 4 ≥6% for patients deemed likely to undergo mitral valve repair n Porcelain aorta or extensively calcified ascending aorta. n Frailty (assessed by in-person cardiac surgeon consultation) n Hostile chest n Severe liver disease / cirrhosis (MELD Score > 12) n Severe pulmonary hypertension (systolic pulmonary artery pressure > 2/3 systemic pressure) n 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. n Evaluable data regarding safety or effectiveness is not available for prohibitive risk Primary patients with an LVEF < 20% or an LVESD > 60 mm. MitraClipTM should be used only when criteria for clip suitability for Primary have been met. n 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 n Evaluable data regarding safety or effectiveness is not available for secondary MR patients with an LVEF < 20% or an LVESD > 70 mm. n 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 G4 procedure. • Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials (nickel / titanium, cobalt, chromium, polyester), and drug reactions to anticoagulation, or antiplatelet drugs • Vascular access complications which may require transfusion or vessel repair including: n wound dehiscence n catheter site reactions n Bleeding (including ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage) n Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, vascular occlusion n Emboli (air thrombotic material, implant, device component) n Peripheral Nerve Injury • Lymphatic complications • Pericardial complications which may require additional intervention, including: n Pericardial effusion n Cardiac tamponade n Pericarditis • Cardiac complications which may require additional interventions or emergency cardiac surgery, including: n Cardiac perforation n Atrial septal defect • Mitral valve complications, which may complicate or prevent later surgical repair, including: n Chordal entanglement / rupture n Single Leaflet Device Attachment (SLDA) n Thrombosis n Dislodgement of previously implanted devices n Tissue damage n Mitral valve stenosis n Persistent or residual mitral regurgitation n Endocarditis • Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias) • Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, and unstable / stable angina) • Venous thromboembolism (including deep vein thrombosis, pulmonary embolism, post procedure pulmonary embolism) • Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA) • System organ failure: n Cardio-respiratory arrest n Worsening heart failure n Pulmonary congestion n Respiratory dysfunction / failure / atelectasis n Renal insufficiency or failure n Shock (including cardiogenic and anaphylactic) • Blood cell disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT)) • Hypotension / hypertension • Infection including: n Urinary Tract Infection (UTI) n Pneumonia n Septicemia • Nausea / vomiting • Chest pain • Dyspnea • Edema • Fever or hyperthermia • Pain • Death • Fluoroscopy, Transesophageal echocardiogram (TEE) and Transthoracic echocardiogram (TTE) -related complications: n Skin injury or tissue changes due to exposure to ionizing radiation n Esophageal irritation n Esophageal perforation n Gastrointestinal bleeding. Caution: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use provided inside the product carton (when available) or at eifu.abbottvascular.com or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. TM Indicates a trademark of the Abbott Group of Companies. www.Cardiovascular.Abbott

PORTICO™ TRANSCATHETER AORTIC VALVE IMPLANTATION SYSTEM

INDICATIONS

The Portico™ Transcatheter Aortic Valve Implantation System is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator).

CONTRAINDICATIONS
The valve is contraindicated for patients with inability to tolerate antiplatelet/anticoagulant therapy or nitinol alloy (nickel and titanium), or who have active infections, including endocarditis.

WARNINGS
Carefully read all warnings, precautions, and instructions for use for all components of the system before use. Failure to read and follow all instructions or failure to observe all stated warnings could cause serious injury or death to the patient.

• Perform Portico™ valve implantation in a facility where emergency aortic valve surgery is available.
• Verify that the patient’s anatomy is consistent with the specifications set forth in the anatomical specifications tables 2 and 3 (found in IFU).
• For single use only. Do not reuse, reprocess, or resterilize the valve, delivery system, or the loading system. Reuse, reprocessing, and/or resterilization creates a risk of contamination of the devices and/or device failure, which could cause patient injury, illness or death.
• Do not manipulate or handle the valve with sharp or pointed objects.
• Rinse the valve as directed before loading the valve onto the delivery system.
• Do not use the valve, the delivery system, or the loading system if the “USE BY” date has elapsed.
• Exercise care to prevent kinking of the delivery system when removing it from the packaging.
• This device contains nitinol, an alloy of nickel and titanium. Persons with allergic reactions to these metals may suffer an allergic reaction to this implant. Prior to implantation, patients should be counseled on the materials contained in the device, as well as potential for allergy/hypersensitivity to these materials.
• Accelerated deterioration of the valve due to calcific degeneration may occur in children, adolescents, young adults, or patients with altered calcium metabolism.

PRECAUTIONS
Pre-Implantation Precautions

• The safety, effectiveness, and durability of a Portico™ valve implanted within a surgical or transcatheter bioprosthesis have not been demonstrated.
• Long-term durability has not been established for the Portico valve. Regular medical follow-up is advised to evaluate valve performance.
• For transaortic access, ensure the access site and trajectory are free of internal patent right internal mammary artery (RIMA) or pre-existing patent RIMA graft.
• For subclavian/axillary access, use caution in patients with mammary artery grafts.
• Balloon aortic valvuloplasty (BAV) of the native aortic valve is recommended prior to delivery system insertion. The balloon size chosen should be appropriate, not exceeding the minimum diameter of the native aortic annulus as assessed by CT imaging to minimize risk of annular rupture and not undersized to minimize risk of stent under-expansion which could lead to paravalvular leak (PVL) or device migration.
• Do not use the valve if the shipping temperature indicator on the product package has turned red, or if the valve has been improperly stored in temperature conditions outside of the 5°C–25°C (41°F–77°F) range.
• Do not use the valve if the tamper-evident container seal is damaged, broken, or missing, or if fluid is leaking from the packaging.
• Do not advance the delivery system without the guidewire extending from the tip.
• Do not use the valve without thoroughly rinsing as directed.
• Do not use the delivery system without thoroughly flushing as described in the "Directions for Use" section.
• The safety and effectiveness of the Portico™ valve and FlexNav™ delivery system have not been evaluated in the following patient populations:

- Congenital unicuspid or bicuspid valve, or any leaflet configuration other than tricuspid
- Severe ventricular dysfunction with left ventricular ejection fraction <20%
- Non-calcific aortic annulus
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Patients at low or intermediate surgical risk
- Patients who are pregnant or breastfeeding
- Pediatric patients (less than 21 years of age)
- Patients with a pre-existing prosthetic heart valve or prosthetic ring in any position
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation > 3+)
- Patients with severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the LVOT, severe (greater than 3+) mitral insufficiency, or severe mitral stenosis with pulmonary compromise
- Blood dyscrasias as defined: leukopenia (WBC<3000 mm³), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count <50,000 cells/mm³)
- Patients with untreated clinically significant coronary artery disease requiring revascularization
- Patients with bulky calcified aortic valve leaflets in close proximity to coronary ostia
- Hypertrophic cardiomyopathy with or without obstruction (HOCM)
- Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring chronic dialysis
- Hemodynamic instability requiring inotropic support or mechanical heart assistance
- Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma (especially if thick [> 5 mm], protruding or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe “unfolding” and tortuosity of the thoracic aorta
- Patients with known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media which cannot be adequately premedicated
- Patients with access characteristics that would preclude safe placement of the introducer sheath, when necessary, such as severe obstructive calcification, or severe tortuosity

Implantation Precautions

• To minimize risk of guidewire perforations in the left ventricle, a manufacturer pre-shaped guidewire should be used during the procedure and during valve deployment.
• Do not deploy the valve if excessive resistance to deployment is encountered. If the valve does not deploy easily, re-sheath the valve, remove it from the patient, and use a different valve and delivery system.
• Follow the procedure in “Implanting the Valve” to reposition the valve or to remove the valve from the patient.
• Do not attempt to reposition the valve by advancing it distally unless the valve has been fully re-sheathed within the delivery system.
• Do not re-sheath the valve more than two times prior to final valve release. Additional re-sheath attempts may compromise product performance.
• To minimize likelihood of permanent pacemaker implantation (PPI): a) maintain implant depth of 3mm, and b) limit manipulations across the LVOT.

Post-Implantation Precautions

• In the event that a post-implant balloon dilatation is performed to address paravalvular leak (PVL), valve size, patient anatomy, and implant depth must be considered when selecting the size of the balloon for dilatation. The balloon size chosen should not exceed the mean diameter of the native aortic annulus. Moderate or Severe PVL should be addressed at the time of the TAVI procedure.
• Exercise care when removing the delivery system from the patient.
• Exercise care when crossing the valve with adjunctive devices.
• Once the valve is fully deployed, repositioning and retrieval of the valve is not possible. Attempted retrieval (e.g., use of a guidewire, snare, or forceps) may cause aortic root, coronary artery, and/or myocardial damage.
• Valve recipients should be maintained on antiplatelet and/or anticoagulant therapy post procedure, per institutional standards and established guidelines, except when contraindicated, using individualized treatment as determined by their physician.
• Post-implant monitoring and/or possible electrophysiology evaluation may be considered in patients with transient high degree or complete AV block or other conduction disturbances during or following implantation of the valve. This may include continuous ECG monitoring after hospital discharge.

POTENTIAL ADVERSE EVENTS
Adverse events potentially associated with the use of transcatheter bioprosthetic heart valves include but are not limited to:

• access site complications (e.g., pain, bleeding, infection, hematoma, pseudoaneurysm, etc.)
• acute coronary obstruction
• acute myocardial infarction
• allergic reaction to antiplatelet agents, contrast medium, or valve components
• aortic rupture
• ascending aorta trauma
• atrio-ventricular node block
• cardiac arrhythmias
• conduction system injury
• conversion to open surgical procedure
• death
• dissection
• embolism
• emergent balloon valvuloplasty
• emergent percutaneous coronary intervention (PCI)
• emergent surgery (i.e., coronary artery bypass, heart valve replacement)
• endocarditis
• explantation
• heart failure
• hemodynamic compromise
• hemolysis
• hemolytic anemia
• hemorrhage
• hypotension or hypertension
• infection
• myocardial ischemia
• mitral valve insufficiency
• multi-organ failure
• non-structural dysfunction (i.e., entrapment by pannus, paravalvular leak, inappropriate sizing or positioning)
• pannus
• pericardial effusion
• perforation of the myocardium, ventricle, or a blood vessel
• permanent disability
• permanent pacemaker
• regurgitation
• renal insufficiency or renal failure
• reoperation
• respiratory failure
• sepsis
• stroke
• structural deterioration (i.e., calcification, leaflet tear)
• thrombosis
• tamponade
• transfusion
• valve embolization or migration
• vessel dissection or spasm