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INDICATION FOR USE

The Tendyne™ Transcatheter Mitral Valve System is indicated for the treatment of symptomatic severe mitral valve dysfunction (moderate-to-severe or severe mitral regurgitation (MR), severe mitral stenosis (MS), or moderate MR with moderate or greater MS) associated with severe mitral annular calcification (MAC) in patients who are deemed unsuitable for mitral valve surgery or transcatheter edge-to-edge repair by a multidisciplinary heart team.

CONTRAINDICATIONS

The Tendyne™ Transcatheter Mitral Valve System is contraindicated in patients with:

• anticoagulation/antiplatelet intolerance;

• sepsis or active endocarditis;

• evidence of left ventricular or left atrial thrombus at risk of embolization;

• a thin or fragile apex rendering the subject unsuitable for a transapical procedure; or

• untreatable hypersensitivity to nickel or titanium

Patients, not deemed a candidate by the local heart team based on clinical or anatomical factors should not have the Tendyne™ Transcatheter Mitral Valve procedure.

WARNINGS

• The valve implant procedure should only be performed where emergency mitral valve surgery can be performed.

• All sterile supplied products are for single use only. Do not reuse, reprocess, or re-sterilize components that are provided sterile. Reuse, reprocessing, or re-sterilization of these components may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.

• Inspect all products prior to use. Do not use the valve or any component of the System if the seal or sterile barrier is compromised or if the product has been dropped, damaged, or mishandled in any way.

• Do not use if the ‘Use By’ date specified on the package has elapsed.

• Do not manipulate or handle the valve with sharp or pointed objects.

• If a valve is inserted into a patient and then retrieved, it may not be reused. Do not attempt to reload it on the same or any other Delivery System.

• Failure to properly clean and/or re-sterilize the reusable stand and reusable weight prior to use may result in infections, user injury, or patient injury (see instructions in Section 12.16).

• The Collapsible Dilator is coated with a hydrophilic coating at the distal end of the device for a length of 8.0 centimeters. Please refer to Section 12.6 for further information on how to prepare and use this device to ensure it performs as intended. Failure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.

• Do not apply radial compression to the Retrieval System sheath within the 9 cm to 15 cm markings to prevent sheath damage during valve retrieval.

• Do not use or continue to use a Retrieval System with a damaged sheath.

PRECAUTIONS

Pre-implantation Precautions

• Long-term durability has not been established for the Tendyne™ Mitral Valve. Regular medical follow

up is advised to evaluate valve performance.

• Safety and effectiveness of the Tendyne™ Mitral Valve has not been established for the following specific populations:

·         Patients with coronary artery disease requiring intervention

·         Patients with severe tricuspid regurgitation

·         Patients with tricuspid valve disease requiring surgery

·         Patients with severe right ventricular dysfunction

·         Patients with hypertrophic or restrictive cardiomyopathy

·         Patients who are pregnant or breastfeeding

·         Pediatric patients (less than 18 years of age)

• Pre-procedural planning, including transesophageal echocardiography and contrast-enhanced cardiac CT, should be performed to evaluate anatomic compatibility with the Tendyne prosthesis.

• Do not use the valve if there is any damage to the container (e.g., cracked jar or lid, leakage, broken or missing seals). Do not use the valve if the container is leaking or if the glutaraldehyde storage solution does not completely cover the valve.

• Do not freeze or expose to extreme heat. Check the temperature indicator prior to use. Do not use if the temperature indicator identifies exposure to a high or low temperature.

• The valve and the glutaraldehyde storage solution are sterile. The outside of the valve container is non-sterile and must not be placed in the sterile field.

• Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure to the vapors. Use only with adequate ventilation. If skin contact occurs,

immediately flush the affected area with water. In the event of eye contact, flush with water and seek medical attention immediately. For more information about glutaraldehyde exposure, request a Safety Data Sheet (SDS) from ������Ƶ.

• Care should be exercised in patients with hypersensitivities or allergies to aldehyde, silicone, polymeric materials and/or contrast.

• Do not use the valve without thoroughly rinsing it, as directed. Adequate rinsing of the valve with sterile heparinized saline is mandatory before implantation (see Instructions for Use in Section 12.4).

• During rinsing, do not touch the leaflets or squeeze the valve.

• Do not expose the valve to solutions other than the storage and rinse solutions.

• Do not add antibiotics or any other substance (other than heparin) to either the storage or rinse

solutions.

• Do not allow the valve to dry. Maintain tissue hydration with irrigation or immersion.

• If a valve is damaged during loading, do not use or attempt to repair it.

• Failure to properly clean and dry the reusable stand and reusable weight may lead to a reduction in device life. Do not use ultrasonic cleaning processes, steel wool, metallic wire brushes, pipe cleaners, or abrasive detergents. Do not use saline to clean or soak the device. Do not use chlorine bleach (see Instructions for Use in Section 12.16).

Implantation Precautions

• The valve is to be used in conjunction with the Tendyne™ Delivery and Retrieval Systems only.

• Do not introduce air into the System. Ensure that the components remain free of air by flushing with sterile saline.

• Do not deform the valve more than what is necessary for loading and implantation.

• Do not use Delivery System or Retrieval System components if they have been dropped, damaged, or mishandled in any way.

• Monitor valve position and performance if making induced volume or hemodynamic changes.

POTENTIAL COMPLICATIONS AND ADVERSE EVENTS

Adverse events potentially associated with use of the Tendyne™ Transcatheter Mitral Valve System may include, but are not limited to, the following:

• Death

• Adverse foreign body response

• Adverse reaction to anesthesia

• Allergic reaction

• Anemia

• Annular dissection

• Aortic insufficiency

• Atrial or ventricular injury

• Atrial Septal Defect (resulting from transseptal mitral valvuloplasty, if performed)

• Bioprosthetic valve dysfunction

• Bleeding complications

• Blood loss which may require transfusion

• Cardiac arrest

• Cardiac perforation

• Conduction defect with or without need for pacemaker

• Cardiac arrhythmia, atrial or ventricular

• Damage to cardiac tissue and/or structures

• Decreased LV function and/or cardiac output

• Device embolism

• Device erosion, migration or malposition

• Device thrombosis

• Embolism (air, blood clot, calcium, tissue, etc.)

• Emergency surgery

• Endocarditis

• Esophageal irritation, stricture, or perforation

• Fever

• Foreign body response

• Heart Failure, new or worsening

• Hematoma

• Hemolysis

• Hypotension

• Infection / Sepsis

• Leaflet, chordal, papillary or ventricular rupture (resulting from mitral valvuloplasty, if performed)

• Liver failure

• Mitral valve injury

• Mitral valve prolapse / stenosis

• Myocardial infarction

• Obstruction

• Pain

• Pleural effusion

• Pulmonary embolism

• Pulmonary hypertension

• Paravalvular leak

• Pericardial effusion / tamponade

• Renal insufficiency or failure

• Respiratory difficulty, insufficiency or failure

• Stroke or transient ischemic attack

• Tear or damage to device

• Vascular and access-related complications

• Worsening of mitral regurgitation

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What are the Epic™ Plus Valve and Epic™ Plus Supra Valve Approved for?

The Epic™ Plus valve is for use in replacement of a native (natural) aortic and/or mitral heart valve that is diseased, damaged, or does not function properly. It may also be used to replace a previously implanted prosthetic aortic and/or mitral heart valve.

The Epic™ Plus Supra valve is for use in replacement of a native (natural) aortic heart valve that is diseased, damaged, or does not function properly. It may also be used to replace a previously implanted prosthetic aortic heart valve.

Who should not receive the Epic™ Plus Valve or Epic™ Plus Supra Valve?

There are no known contraindications with the use of the Epic™ Plus valve or Epic™ Plus Supra valve.

What are the possible complication associated with the Epic™ Plus Valve or Epic™ Plus Supra Valve?

Potential adverse events that may occur during or after implantation of the Epic™ Plus valve or Epic™ Plus Supra valve include, but are not limited to: chest pain; loss of regular heart rhythm; infection or inflammation in the heart; failure of the heart to pump enough blood for the body’s needs; destruction of red blood cells; anemia caused by excessive destruction of red blood cells; excessive bleeding related to use of blood thinners; leak near the valve; heart attack; nonstructural destruction of the valve; valve unable to close completely, thus allowing blood to flow backward through the valve; stroke; structural deterioration (calcification, leaflet tear, perforation, or other); blood clot that blocks a vessel; formation of a blood clot near or attached to the valve.

It is possible that these complications could lead to reoperation, surgical removal of the valve, permanent disability, or death.

What are the warnings associated with the Epic™ Plus Valve or Epic™ Plus Supra Valve?

Faster deterioration of the Epic™ Plus valve and Epic™ Plus Supra valve may occur in children, adolescents, or young adults; patients with a disease that results in more calcium in the blood, such as hyperparathyroidism or chronic renal failure; or individuals requiring hemodialysis.

Talk to your doctor to learn more about the risks associated with use of the Epic™ Plus valve or Epic™ Plus Supra valve.

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Important Safety Information

Masters Series Mechanical Heart Valve

What is the SJM™ Masters Series Mechanical Heart Valve approved for?

The SJM™ Masters Series Mechanical Heart Valve is for use in replacement of a native (natural) aortic or mitral heart valve that is diseased, damaged, or does not function properly. It may also be used to replace a previously implanted prosthetic aortic or mitral heart valve. 

Who should not receive the SJM™ Masters Series Mechanical Heart Valve?

Patients who are unable to tolerate blood-thinning medication should not receive the SJM™ Masters Series Mechanical Heart Valve.

What are the possible complications associated with the SJM™ Masters Series Mechanical Heart Valve?

Potential adverse events that may occur during or after implantation of the SJM™ Masters Series Mechanical Heart Valve include, but are not limited to: destruction of red blood cells; infections; blood clot that forms in a vein or blocks a vessel; breakdown of sutures that connect the valve to the heart; poor blood flow; excessive bleeding related to use of blood thinners; failure of the valve; heart failure; death.

It is possible that these complications could lead to reoperation or surgical removal of the valve.

Talk to your doctor to learn more about the risks associated with use of the SJM™ Masters Series Mechanical Heart Valve.

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What is the SJM™ Masters Series Mechanical Heart Valve approved for?

The SJM™ Masters Series Mechanical Heart Valve is for use in replacement of a native (natural) aortic or mitral heart valve that is diseased, damaged, or does not function properly. It may also be used to replace a previously implanted prosthetic aortic or mitral heart valve. 

Who should not receive the SJM™ Masters Series Mechanical Heart Valve?

Patients who are unable to take blood-thinning medication should not receive the SJM™ Masters Series Mechanical Heart Valve.

What are the possible complications associated with the SJM™ Masters Series Mechanical Heart Valve?

Potential adverse events that may occur during or after implantation of the SJM™ Masters Series Mechanical Heart Valve include, but are not limited to: destruction of red blood cells; infections; blood clot that forms in a vein or blocks a vessel; breakdown of sutures that connect the valve to the heart; poor blood flow; excessive bleeding related to use of blood thinners; failure of the valve; failure of the heart to pump enough blood for the body’s needs; heart failure; stroke; death.

It is possible that these complications could lead to reoperation or surgical removal of the valve.

Talk to your doctor to learn more about the risks associated with use of the SJM™ Masters Series Mechanical Heart Valve.