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Important Safety Information

MITRACLIP™ CLIP DELIVERY SYSTEM

• The MitraClip™ 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 teamwhich includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve diseaseand in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.
• The MitraClip™ G4 Systemwhen used with maximally tolerated guideline-directed medical therapy (GDMT)is indicated for the treatment of symptomaticmoderate-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 G4 System is contraindicated in patients with the following conditions: Patients who cannot tolerateincluding allergy or hypersensitivity toprocedural anticoagulation or post procedural anti-platelet regime; Patients with known hypersensitivity to clip components (nickel / titaniumcobaltchromiumpolyester)or with contrast sensitivity; Active endocarditis of the mitral valve; Rheumatic mitral valve disease; Evidence of intracardiacinferior vena cava (IVC) or femoral venous thrombus.

Potential Complications and Adverse Events

The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClip G4 procedure: Allergic reactions or hypersensitivity to latexcontrast agentanaesthesiadevice materials (nickel / titaniumcobaltchromiumpolyester)and drug reactions to anticoagulationor antiplatelet drugsVascular access complications which may require transfusion or vessel repair including: wound dehiscencecatheter site reactionsBleeding (including ecchymosisoozinghematomahemorrhageretroperitoneal hemorrhage)Arteriovenous fistulapseudoaneurysmaneurysmdissectionperforation / rupturevascular occlusionEmboli (air thrombotic materialimplantdevice component); Peripheral Nerve Injury; Lymphatic complications; Pericardial complications which may require additional interventionincluding: Pericardial effuse onCardiac tamponadePericarditis; Cardiac complications which may require additional interventions or emergency cardiac surgeryincluding: Cardiac perforationAtrial septal defect; Mitral valve complicationswhich may complicate or prevent later surgical repairincluding: Chordal entanglement / ruptureSingle Leaflet Device Attachment (SLDA)ThrombosisDislodgement of previously implanted devicesTissue damageMitral valve stenosisPersistent or residual mitral regurgitationEndocarditis; Cardiac arrhythmias (including conduction disordersatrial arrhythmiasventricular arrhythmias); Cardiac ischemic conditions (including myocardial infarctionmyocardial ischemiaand unstable / stable angina); Venous thromboembolism (including deep vein thrombosispulmonary embolismpost procedure pulmonary embolism); Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA); System organ failure: Cardio-respiratory arrestWorsening heart failurePulmonary congestionRespiratory dysfunction / failure / atelectasisRenal insufficiency or failureShock (including cardiogenic and anaphylactic); Blood cell disorders (including coagulopathyhemolysisand Heparin Induced Thrombocytopenia (HIT)); Hypotension / hypertension; Infection including: Urinary Tract Infection (UTI)PneumoniaSepticemia; Nausea / vomiting; Chest pain; Dyspnea; Edema; Fever or hyperthermia; Pain; Death; FluoroscopyTransesophageal echocardiogram (TEE) and Transthoracic echocardiogram (TTE) -related complications: Skin injury or tissue changes due to exposure to ionizing radiationEsophageal irritation; Esophageal perforationGastrointestinal bleeding.