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INDICATION FOR USE:

The MitraClip™ NTR/XTR Clip Delivery 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 MitraClip™ NTR/XTR Clip Delivery 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 MitraClip™ NTR/XTR Clip Delivery System is contraindicated in patients with the following conditions:

• Patients who cannot tolerate procedural anticoagulation or post procedural antiplatelet 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 MitraClip™ outside of the labeled indication.
• The MitraClip™ 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 MitraClip™ System to avoid user injury.
• 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 MitraClip™ 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 MitraClip™ 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, MitraClip™ Implant); Emergency cardiac surgery; Endocarditis; Esophageal irritation; Esophageal perforation or stricture; Failure to deliver MitraClip™ to the intended site; Failure to retrieve MitraClip™ 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; MitraClip™ Implant erosion, migration or malposition; MitraClip™ Implant thrombosis; MitraClip™ 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

FreeStyle Libre and FreeStyle Libre 14 day Flash Glucose Monitoring systems are continuous glucose monitoring (CGM) devices indicated for replacing blood glucose testing and detecting trends and tracking patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments in persons (age 18 and older) with diabetes. The systems are intended for single patient use and require a prescription.

CONTRAINDICATIONS:

Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment.

WARNINGS/LIMITATIONS:

Do not ignore symptoms that may be due to low or high blood glucose, hypoglycemic unawareness, or dehydration. Check sensor glucose readings with a blood glucose meter when Check Blood Glucose symbol appears, when symptoms do not match system readings, or when readings are suspected to be inaccurate. The system does not have alarms unless the sensor is scanned, and the system contains small parts that may be dangerous if swallowed. The system is not approved for pregnant women, persons on dialysis, or critically-ill population. Sensor placement is not approved for sites other than the back of the arm and standard precautions for transmission of blood borne pathogens should be taken. The built-in blood glucose meter is not for use on dehydrated, hypotensive, in shock, hyperglycemic-hyperosmolar state, with or without ketosis, neonates, critically-ill patients, or for diagnosis or screening of diabetes. When using FreeStyle LibreLink app, access to a blood glucose monitoring system is required as the app does not provide one. Review all product information before use or contact Abbott Toll Free (855-632-8658) or visit www.freestylelibre.us for detailed indications for use and safety information.

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
• 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.
• 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