TM
Tendyne Weight: The Tendyne Weight is a reusable
accessory intended for preparation of the Pad
Positioning System.
Tendyne Stand: The Tendyne Stand is a reusable
accessory intended to hold the Loading and Delivery
Systems during preparation of the Tendyne Mitral Valve
System.
Tendyne Stand Components: The Tendyne Stand
Components are sterile accessories used with the
Tendyne Stand during preparation of the Tendyne
Mitral Valve System.
Contraindications
The Tendyne
TM
Mitral Valve System is contraindicated
for patients:
Who cannot tolerate procedural anticoagulation or
post-procedural antiplatelet/anticoagulation regimen
With sepsis including active endocarditis
With evidence of left ventricular or atrial thrombus
With vegetation or mass on the mitral valve
With a thin or fragile apex rendering the subject
unsuitable for a transapical procedure
With hypersensitivity to nickel or titanium
4. Warnings and Precautions
4.1. Warnings
The valve implant procedure should only be performed
where emergency mitral valve surgery can be
performed promptly.
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.
Care should be exercised in patients with
hypersensitivities or allergies to aldehyde, silicone,
polymeric materials and/or contrast.
Inspect all product 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.
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 10.5 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.
4.2. Pre-implantation Precautions
Pre-procedural planning, including transesophageal
echocardiography and contrast-enhanced cardiac CT,
should be performed to evaluate anatomic compatibility
with the Tendyne prosthesis.
The safety and performance of the Tendyne system has
not been established for patients with coronary artery
disease requiring intervention, severe tricuspid
regurgitation, tricuspid valve disease requiring surgery,
severe right ventricular dysfunction, or hypertrophic or
restrictive cardiomyopathy.
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
