MitraClip™

Rx Only

Important Safety Information

MITRACLIP™ CLIP DELIVERY SYSTEM

Indications for Use

The MitraClip™ G5 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™ G5 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™ G5 System is contraindicated for use in patients with the following conditions:

• Intolerance, including allergy or untreatable hypersensitivity to, procedural anticoagulation
• Untreatable hypersensitivity to Implant components (nickel- titanium alloy, cobalt-chromium alloy)
• Active endocarditis or other active infection of the mitral valve

Potential Complications and Adverse Events

The following events have been identified as possible complications of the MitraClip™ G5 procedure:Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials, and drug reactions to anticoagulation, or antiplatelet drugs, additional treatment/surgery from device-related complications, atrial septal defect, bleeding, blood disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT)), Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventriculararrhythmias), Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, unstable angina, and stable angina), Cardiac perforation, Cardiac tamponade, chest pain, death, Dyspnea, Edema, Embolization (device or components of the device), Endocarditis, fever or hyperthermia, Fluoroscopy and Transesophageal echocardiogram (TEE) -related complications: Skin injury or tissue changes due to exposure to ionizing radiation, Esophageal irritation, Esophageal perforation, Gastrointestinal bleeding, Hypotension / hypertension; Infection including: Septicemia; Mitral valve complications, which may complicate or prevent later surgical repair, including: Chordal entanglement / rupture, Single leaflet device attachment (SLDA), dislodgement of previously implanted devices, tissue damage, mitral valve stenosis, worsening, persistent or residual regurgitation, nausea or vomiting, pain, Pericardial effusion, stroke / cerebrovascular accident (CVA) and transient ischemic attack (TIA), system organ failure: cardio-respiratory arrest, worsening heart failure, Pulmonary congestion, Respiratory dysfunction or failure or atelectasis, Renal insufficiency or failure, Shock (including cardiogenic and anaphylactic), Thrombosis, Vascular access complications which may require additional intervention, including: wound dehiscence, bleeding of the access site, Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation (rupture), vascularocclusion, Embolism (air, thrombus), Peripheral nerve injury, Venous thrombosis (including deep vein thrombosis) and thromboembolism (including pulmonary embolism)