Abbott Tendyne Gebrauchsanweisung Seite 17

immediately. For more information about
glutaraldehyde exposure, request a Safety Data Sheet
(SDS) from Abbott.
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 in Section 10.3).
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.
Failure to properly clean and dry the reusable stand and
reusable weight may lead to a reduction in device life.
Do not use steel wool, wire brushes, pipe cleaners, or
abrasive detergents. Do not use saline to clean or soak
the device. Do not use chlorine bleach.
4.3. 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.
5. Magnetic Resonance (MR) Safety
5.1. MR Conditional
Non-clinical testing has demonstrated that the valve can
be scanned safely under the following conditions:
Static magnetic field of 1.5-Tesla (1.5 T) or 3-Tesla (3 T)
Maximum spatial gradient field of 4,000 G/cm
(40.00 T/m)
TM
IFU, TENDYNE Mitral Valve System
Maximum MR System reported, whole body averaged
specific absorption rate (SAR) of 2.0 W/kg (Normal
Operating Mode).
5.2. Radio Frequency (RF) Heating
Under the scan conditions defined in Section 5, the
valve is expected to produce a maximum temperature
rise of <7.5°C after 15 minutes of continuous scanning.
This level of heating is not expected to be associated
with any adverse physiological effect considering the
heat dissipation caused by the blood flow at the
mitral valve.
CAUTION: The RF heating behavior does not scale with
static field strength. Devices that do not exhibit
detectable heating at one field strength may exhibit
high values of localized heating at another field
strength.
5.3. MR Artifact
In non-clinical testing, the image artifact caused by the
device extends approximately 0.9 cm from the valve
when imaged with a gradient-echo pulse sequence in
a 3 T MRI System.
Limitations
A chest condition preventing transapical access
7. Potential Adverse Events
Adverse events potentially associated with use of the
Tendyne Mitral Valve System may include, but are not
limited to, the following:
• Adverse foreign body response
Adverse reaction to anesthesia
•
Allergic reaction
•
• Anemia
Annular dissection
•
• Aortic insufficiency
Atrial or ventricular injury
•
• Atrial Septal Defect (resulting from mitral
valvuloplasty, if performed)
• Bioprosthetic valve dysfunction
Bleeding complications
•
Blood loss which may require transfusion
•
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