Medtronic Solitaire X SFR4-4-20-05 Gebrauchsanweisung Seite 5

WARNINGS
• To prevent device separation:
• Do not oversize device.
• Do not recover (i.e. pull back) the device when encountering excessive resistance. Instead, resheath
the device with the microcatheter and then remove the entire system under aspiration. If resistance is
encountered during resheathing, discontinue and remove the entire system under aspiration.
• Do not treat patients with known stenosis proximal to the thrombus site.
• This device is supplied STERILE for single use only. Do not reprocess or re-sterilize. Reprocessing and
re-sterilization increase the risks of patient infection and compromised device performance.
CLINICIAN USE INFORMATION
Materials Required
The following parts are required to use the Solitaire™ X Revascularization Device:
• All Solitaire™ X Revascularization Devices should be introduced only through a microcatheter with an inside diameter
of 0.021-0.027 inches.
Compatibility testing has been performed with the Rebar™, Phenom™ and Marksman™ microcatheters.
Refer to the instructions supplied with all interventional devices and materials to be used in conjunction with the Solitaire™
X Revascularization Device for their intended uses, contraindications and potential complications.
Other accessories for performing a procedure and NOT supplied; to be selected based on the physician's experience
and preferences:
• Minimum 5F guide catheter
(NOTE: Users should select a guide catheter with appropriate support to deliver interventional devices. For a guide
catheter a minimum inside diameter 0.061'' is recommended. For a balloon guide catheter ensure to use 8-9F with
minimum inside diameter 0.075")
• Microcatheter (refer to Table 1)
• Guidewire
• Aspiration Device (60 cc syringe or aspiration pump/system)
• Saline solution/heparin-saline continuous flush set
• Rotating Hemostasis Valve (RHV)
• Infusion stand
• Femoral arterial lock
PREPARATION AND PROCEDURE
Preparation
1. Administer anti-coagulation and anti-platelet medications per standard institutional guidelines.
2. Aided by angiographic radiography, determine the location and size of the area to be revascularized.
3. Select a Solitaire™ X Revascularization Device per Table 1.
4. To achieve optimal performance of the Solitaire™ X Revascularization Device and to reduce the risk of
thromboembolic complications, maintain continuous flushing action between a) the femoral arterial sheath and
the guide catheter, b) the microcatheter and the guide catheter and c) the microcatheter and the push wire and the
Solitaire™ X Revascularization Device. Check all connections to make sure that during the continuous flush no air
enters the guide catheter or the microcatheter.
5. Position a suitable guide catheter as close to thrombus site as possible employing a standard method. The guide
catheter should be appropriately sized to retrieve clot if so desired in subsequent steps. Connect a RHV to the fitting
of the guide catheter, and then connect a tube to the continuous flush.
6. With the aid of Table 1, select a microcatheter suitable for advancing the Solitaire™ X Revascularization Device.
7. Connect a second RHV to the fitting of the microcatheter and then connect a tube to the continuous flush.
8. Set the flush rate per standard institutional guidelines.
9. With the aid of a suitable guide wire, advance the microcatheter until the end of the microcatheter is positioned
distal to the thrombus so that the usable length portion of the Solitaire™ X Revascularization Device will extend past
each side of the thrombus in the vessel when fully deployed. Tighten the RHV around the microcatheter. Remove
guide wire.
Delivering the Solitaire™ X Revascularization Device
10. Insert the distal end of the introducer sheath partially into the RHV connected to the microcatheter. Tighten the RHV
and verify that fluid exits the proximal end of the introducer sheath.
11. Loosen the RHV and advance the introducer sheath until it is firmly seated in the hub of the microcatheter. Tighten
the RHV around the introducer sheath to prevent back flow of blood, but not so tight as to damage the Solitaire™ X
Revascularization Device during its introduction into the microcatheter. Confirm that there are no air bubbles trapped
anywhere in the system.
12. Transfer the Solitaire™ X Revascularization Device into the microcatheter by advancing the push wire in a smooth,
continuous manner. Once the flexible portion of the push wire has entered the microcatheter shaft, loosen the RHV
and remove the introducer sheath over the proximal end of the push wire. Once completed, tighten the RHV around
the push wire. Leaving the introducer sheath in place will interrupt normal infusion of flushing solution and allow
back flow of blood into the microcatheter.
13. Visually verify that the flushing solution is infusing normally. Once confirmed, loosen the RHV to advance the push
wire.
14. Once the Solitaire™ X Revascularization Device has been advanced to the fluorosafe marker band begin fluoroscopic
imaging. With the aid of fluoroscopic monitoring, carefully advance the Solitaire™ X Revascularization Device until its
distal markers line up at the end of the microcatheter. The Solitaire™ X Revascularization Device should be positioned
such that the usable length portion of the device will extend past each side of the thrombus in the vessel when the
device is fully deployed.
WARNING
• If excessive resistance is encountered during the delivery of the Solitaire™ X Revascularization Device, discontinue
the delivery and identify the cause of the resistance. Advancement of the Solitaire™ X Revascularizaton Device
against resistance may result in device damage and/or patient injury.
Deploying the Solitaire™ X Revascularization Device
15. Loosen the RHV around the microcatheter. To deploy the Solitaire™ X Revascularization Device, fix the push wire to
maintain the position of the device while carefully withdrawing the microcatheter in the proximal direction.
Solitaire™ X Revascularization Device Deployment
16. Retract the microcatheter until it is just proximal to the proximal marker of the Solitaire™ X Revascularization Device.
Tighten the RHV to prevent any movement of the push wire. The usable length of the deployed Solitaire™ device
should extend past each side of the thrombus.
17. Tighten the RHV around the microcatheter. Angiographically assess the revascularization status of the treated vessel.
Solitaire™ X Revascularization Device Re-Sheathing
If resheathing of the Solitaire™ X Revascularization Device is necessary (e.g. repositioning), follow these steps:
WARNINGS
• Advancing the microcatheter while the device is engaged in clot may lead to embolization of debris.
• Do not advance the microcatheter against any resistance.
• Do not reposition more than two times.
18. Loosen the RHV around the microcatheter and around the push wire. With the aid of fluoroscopic monitoring, hold
the push wire firmly in its position to prevent the Solitaire™ X Revascularization Device from moving.
19. Carefully re-sheath the Solitaire™ X Revascularization Device by advancing the microcatheter over the Solitaire™ X
Revascularization Device until the distal markers of the Solitaire™ X Revascularization Device line up at the end of the
microcatheter as illustrated in Figure 3 below.
If significant resistance is encountered during the re-sheathing process, stop immediately and proceed to
the section below entitled "Revascularization Device Recovery".
Solitaire™ X Revascularization Device Re-sheathing
Revascularization Device Recovery
20. If using balloon guide catheter, inflate guide catheter balloon to occlude vessel as specified in Balloon Guide Catheter
labeling.
21. Loosen the RHV around the microcatheter enough for movement while still maintaining a seal. If desired remove the
microcatheter completely.
22. To retrieve thrombus, withdraw the Solitaire™ X Revascularization Device to the guide catheter tip while applying
aspiration to the guide catheter with the aspiration device. If applicable withdraw the microcatheter and the
Solitaire™ X Revascularization Device as a unit. Never advance the deployed Solitaire™ X Revascularization Device
distally.
23. Apply aspiration to the guide catheter using the aspiration device and recover the Solitaire™ X Revascularization
Device inside guide catheter. Continue aspirating guide catheter until the Solitaire™ X Revascularization Device is
nearly withdrawn from the guide catheter.
5
Figure 2:
Figure 3: