Abbott Tendyne TENDV-LP-29S, Instructions For Use Manual

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IFU, TENDYNE TM Mitral Valve System Page 19 of 284
11. Pull the tether until taut, loosen the Loading
Tube collet, and then remove the Loading
Handle.
12. Alternate pulling the leader and handle to fully
remove tether and prevent entanglement.
NOTE: Verify the tether is not tangled by looking
through the opening where the knob was
removed on the Loading Handle.
13. Tap the sheath and Loading Tube to remove
any air bubbles that may reside behind the
valve after loading. The flush may also be
turned on and off during this step to replace
any saline lost during Loading Handle removal.
Figure 14. Tendyne TM Delivery System. Upper image: top view.
Lower image: bottom view.
1. Sheath Retraction Knob – Knob 3
2. Tether Retention Knob – Knob 2
3. Delivery Push Knob – Knob 1
4. Top Alignment Window
5. Bottom Alignment Window
14. Confirm the sheath retraction mechanism of
the Delivery Handle is properly positioned by
checking the Bottom Alignment Window to
assure that the tab is centered. Adjust travel
using the Sheath Retraction Knob – Knob 3 if
necessary.
15. Confirm the Delivery Push Knob – Knob 1 is
fully rotated counterclockwise.
NOTE: Do not over rotate and damage the
mechanism.
16. Attach a Tuohy-Borst with side extension to the
luer connector on the end of the Delivery
Handle and then attach a 1-way stopcock to
the Extension Tube on the Tuohy-Borst valve.
17. Ensure that the Tuohy-Borst valve is open.
Carefully inspect the valve assembly at the
braided tether to nitinol leader joint and verify
that there is no evidence of damage.
CAUTION: Do not use the valve if there is any
sign of damage or deterioration.
18. Feed the tether through the Delivery Handle
until the tether leader exits the hub of the
Delivery Handle and Tuohy-Borst valve.
19. Maintain tension on the tether and attach the
Delivery Handle to the Loading Tube, ensuring
the Delivery Handle is in proper alignment with
the Loading Tube. Clip one end of the Delivery
Handle into Rotating Clip - Clip 1.
The black indicator on the Loading Tube should
align with the Top Alignment Window.
20. Place the tether leader into the retention
openings on the hub of the Delivery Handle.
NOTE: Four (4) to six (6) inches (10 to 15
centimeters) of leader should be in the hub for
retention.
21. Make sure that all luer connections are tight
and secure. Flush the Delivery Handle with
saline until saline exits the Tuohy-Borst valve
and 1-way stopcock. Close the Tuohy-Borst
valve and the 1-way stopcock.
22. Remove the shipping mandrel from the
collapsible dilator and flush the dilator lumen
with sterile saline
23. Verify the Tether Retention Knob - Knob 2 is
not engaged with the tether leader.
10.9. Preparing for the Transapical Procedure
The valve should be implanted with sterile
technique using primarily transesophageal
echocardiographic guidance. In addition,
transthoracic echocardiographic and fluoroscopic
imaging modalities may be used.
WARNING: Only physicians who have
undergone training on use of the TENDYNE
TM
Mitral Valve System should operate this
product.
1. Prepare the thoracic access site using standard
practice.
2. Determine the proper trajectory from the
ventricular myocardium to the mitral valve
using echocardiography guidance.
3. Determine proper apical access site using
transesophageal echocardiography. Puncture
the myocardium with the introducer needle
and insert a standard 0.035” (0.89 mm) guide