INDICATIONS, SAFETY & WARNINGS

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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.

CardioMEMS™ HF System Indications and Usage: The CardioMEMS HF System is indicated for wirelessly measuring and monitoring pulmonary artery (PA) pressure and heart rate in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year. The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations.

CardioMEMS HF System Contraindications: The CardioMEMS HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant.

CardioMEMS HF System Potential Adverse Events: Potential adverse events associated with the implantation procedure include, but are not limited to, the following: infection, arrhythmias, bleeding, hematoma, thrombus, myocardial infarction, transient ischemic attack, stroke, death, and device embolization.

myCardioMEMS™ Mobile App Limitations: Patients must use their own Apple‡ or Android‡ mobile device to receive and transmit information to the myCardioMEMS Mobile App. To do so the device must be powered on, app must be installed and data coverage (cellular or Wi-Fi‡) available. The myCardioMEMS App can provide notification of medication adjustments and reminders, requests for lab work and acknowledgement that the PA pressure readings have been received. However there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of the notifications and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, clinic environment, schedule/configuration changes, or data processing.

INDICATIONS, SAFETY & WARNINGS

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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.

HeartMate 3™ LVAS 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 patients with advanced refractory left ventricular heart failure.

HeartMate II™ LVAS Indications: The HeartMate II Left Ventricular Assist System is indicated for use as a “bridge to transplantation” for cardiac transplant candidates who are at risk of imminent death from non-reversible left ventricle failure. It is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure, who have received optimal medical therapy for at least 45 of the last 60 days, and who are not candidates for cardiac transplantation. The HeartMate II Left Ventricular Assist System is intended for use both inside and outside of the hospital, or for transportation of Left Ventricular Assist Device patients via ground ambulance, airplane, or helicopter.

HeartMate 3 and HeartMate II LVAS Contraindications: The HeartMate 3 and HeartMate II Left Ventricular Assist Systems are contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.

HeartMate 3 and HeartMate II LVAS Adverse Events: Adverse events that may be associated with the use of the HeartMate 3 or HeartMate II Left Ventricular Assist System are listed below: 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) and possible pump thrombosis.

MITRACLIP CLIP DELIVERY SYSTEMS

INDICATION FOR USE

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

• Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet 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 of the MitraClip™ should be restricted to those physicians trained to perform invasive endovascular and transseptal procedures and those trained in the proper use of the system.

• 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 or other serious injury or death.

• 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

IMPORTANT SAFETY INFORMATION 

INDICATIONS AND USAGE 

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 

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 Piccolo 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

IMPORTANT SAFETY INFORMATION

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 mitral or aortic heart valve. This device may also be used to replace a previously implanted mitral or aortic prosthetic heart valve. The sizer model 905-15 is indicated to confirm size selection of the 15AHPJ-505 and 15MHPJ-505 valves.

CONTRAINDICATIONS

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

The sizer model 905-15 is contraindicated for use with any devices other than the 15 AHPJ-505 and 15MHPJ-505 valves. Any sizer sterilization method other than steam is contraindicated.

WARNINGS

Valve

• For single use only. Attempts to reuse the valve may result in valve malfunction, inadequate sterilization, or patient harm.

• Use only St. Jude Medical mechanical heart valve sizers.

• Do not use if:

• The valve has been dropped, damaged, or mishandled in anyway.

• The expiration date has elapsed.

• The tamper-evident container seal or inner/ outer tray seals are damaged, broken, or missing.

• Remove any residual tissue that may impair valve size selection, correct seating of the valve, rotation of the valve, or leaflet motion.

• Proper valve size selection is crucial. Do not oversize the valve. If the native annulus measurement falls between two SJM Masters Series Mechanical Heart Valve sizes, use the smaller prosthetic valve size. 

• The outer tray is not sterile, and should not be placed in the sterile field.

• To minimize direct handling of the valve during implantation, do not remove the holder/rotator until the valve has been seated in the annulus.

• Do not use hard or rigid instruments to test leaflet mobility, as this may result in structural damage to the valve or thromboembolic complications. Use a St. Jude Medical leaflet tester to gently test valve leaflet mobility. 

• Place sutures in the outer half of the valve sewing cuff.

• Never apply force to the valve leaflets. Force may cause structural damage to the valve.

• Use only SJM Valve Holder/Rotators to perform valve rotation. Use of other instruments could result in structural damage. The valve holder/rotator is intended for single use only and should be discarded after surgery.

• The two retention sutures on the valve holder/ rotator must be cut and removed before the valve can be rotated.

• Do not pass catheters or other instruments through St. Jude Medical mechanical heart valves. This could result in scratched or damaged valve components, leaflet fracture, or dislodgment.

• Cut suture ends short, especially in the vicinity of the pivot guards, to prevent leaflet impingement.

PRECAUTIONS

Valve

• Do not touch the prosthetic valve unnecessarily, even with gloved hands. This may cause scratches or surface imperfections that may lead to thrombus formation.

• Be careful not to cut or tear the valve sewing cuff when removing the identification tag and the holder/rotator from the valve.

• Before placing sutures in the valve sewing cuff, verify that the valve is mounted correctly on the valve holder/rotator.

• To avoid structural damage, the valve must be rotated in the fully open position.

• To minimize rotational torque, verify that the valve holder/rotator is properly seated in the valve, and that the valve holder handle is perpendicular to the valve.

• Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.

• Implantation of a prosthetic valve too large for the annulus may result in increased risk of damage to the conductive system, obstruction of the left ventricular outflow tract, impairment of valve mobility, damage to the left circumflex artery, and damage to surrounding tissues or cardiac structures including obstruction and/or distortion of adjacent cardiac structures.

NOTE: PROSPECTIVE DATA TO SUPPORT SAFETY AND EFFECTIVENESS OF THE 15-mm HP VALVE IMPLANTED IN THE AORTIC POSITION ARE NOT CURRENTLY AVAILABLE.

Sizer

• Instruments must be cleaned and sterilized prior to use.

• Do not use cracked, deformed, discolored/rusted, or damaged instruments.

• Improper cleaning may result in an immunological or toxic reaction.

• Instrument sterilization temperature must not exceed 280°F (138°C).

• Do not bend flexible instrument handles beyond a 90° angle.

• Instruments must be sterilized in a tray or container that is permeable to steam.

• Do not expose instruments to cleaning or rinse agents that are not compatible with polysulfone or polyphenylsulfone.

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, heart block requiring pacemaker implant, prosthetic failure, adjacent cardiac structure interference, heart failure, stroke, myocardial infarction, or death. Any of these complications may require reoperation or explantation of the device.