Abbott IFU Gebrauchsanweisung Seite 21

rotating Retraction Knob - Knob 3 in the
direction of the indicator arrows.
CAUTION: Do not recapture and redeploy the
valve more than five (5) times.
7. Remove tether leader from the holder.
Manually grasp the tether leader, then loosen
the Tuohy-Borst valve and Tether Retention
Knob - Knob 2.
8. Remove Delivery Handle while maintaining
tether tension.
CAUTION: Maintain tether leader tension.
10.12. Securing the Tether
1. Confirm the Apical Pad is attached to the
Positioning Handle.
2. Thread the Apical Pad and Positioning Handle
over the tether and advance it until the Tether
Marker exits the TLS.
3. Engage the pin on the TLS with the tether
marker flush to the surface of the TLS.
4. Depress the Release Button (tensioning dial
button) on the Lead Screw Knob (tensioning
dial) to advance the Apical Pad to the
myocardium while confirming the Apical Pad
Stem enters the myocardium. Maintain tension
on the System to keep the valve seated in the
annulus.
5. Assure that no objects (i.e., suture lines) are
trapped between the myocardium and the Pad
before beginning the final tightening of the
Apical Pad.
6. Use the Lead Screw Knob to adjust tether
tension to attain proper seating of the valve.
Refer to Appendix A for tether load tensions
based on the patient's hemodynamic
conditions.
7. Use echocardiography to evaluate valve
performance and position, ensuring valve is
well seated within the mitral annulus without
paravalvular leak or central mitral
regurgitation. Check the physiologic trans-
mitral and LVOT pressure gradients.
If optimal performance is not achieved and
valve retrieval is desired, do not trim tether.
Refer to Section 10.13 for retrieval procedures.
8. Fasten the Apical Pad using the Lock Wheel -
Center Knob to pin the tether.
IFU, TENDYNE Mitral Valve System
TM
Confirm the two (2) alignment holes on the
Apical Pad are aligned as visual confirmation
that the Apical Pad is secured to the tether.
9. Disengage the pin at the TLS to free the tether.
10. Turn the Pad Release Knob to release the arms
and detach the Apical Pad.
11. Remove the Positioning Handle.
12. After optimal valve orientation and seating is
confirmed, trim the tether to approximately
5 centimeters (cm).
13. Close the surgical incision using standard
practice.
10.13. Retrieving the Valve with the Retrieval System
(if required)
NOTE: Retrieval can only be accomplished
intraoperatively, prior to trimming the tether.
1. Attach the retaining ring onto the retrieval tool
assembly.
2. Mount the retrieval dilator assembly onto the
retrieval tool. Engage the slide bar locking
mechanism to lock the retrieval dilator
assembly. Ensure the bottom thumbscrew is
unlocked.
3. Connect the extension tube and 1-way
stopcock. Flush the retrieval sheath assembly
and retrieval dilator assembly. Close the 1-way
stopcock.
4. Attach the retrieval sheath assembly and the
retrieval dilator assembly to the retrieval tool
assembly and load the cable tie.
5. Position the retaining ring at the proximal edge
of the retrieval dilator assembly.
6. Run a continuous slow saline flush through the
retrieval tool assembly.
7. If the Apical Pad is present, first remove the
Apical Pad using the pad positioning System.
Follow these steps if the Apical Pad has been
pinned to the tether:
a. Load the Positioning Handle over the
tether and advance it up to the Apical
Pad.
b. Turn the Pad Release Knob to engage
the arms with the Apical Pad. Ensure
that the D-shaped drive feature is
engaged with the D-shaped pocket on
the Apical Pad.
Page 21 of 284