Clinical Use Information; Materials Recommended; Pre-Procedure; Preparation - Stryker Target Gebrauchsanweisung

• Ischemia
• Neurological/intracranial sequelae
• Post-embolization syndrome (fever, increased white blood cell count, discomfort)
• TIA/stroke
• Vasospasm
• Vessel occlusion or closure
• Vessel perforation
• Dissection
• Trauma or damage
• Vessel rupture
• Vessel thrombosis
Other procedural complications including but not limited to:
• Anesthetic and contrast media risks
• Hypotension
• Hypertension
• Access site complications

7. ClInICal Use InforMaTIon

This device should only be used by physicians who have received appropriate
training in interventional neuroradiology or interventional radiology and preclinical
training on the use of this device as established by stryker neurovascular.

7.1 Materials recommended

Caution: Besides the number of InZone
complete the case, there must be an extra InZone Detachment System unit as
back up.
In addition to the Target Detachable Coils and necessary InZone Detachment
®
Systems, M00345100950 (one for backup), the following items are required:
• 5F (min. internal diameter 1.35 mm [0.053 in]) or 6F (min. internal diameter
1.63 mm [0.064 in]) non-tapered guiding catheter to facilitate Stryker
Neurovascular 2-tip microcatheter access to the vessel
• Continuous flush setup with two rotating hemostatic valves (RHVs), three bags
of appropriate flush, one 3-way stopcock, and one 1-way stopcock
• Stryker Neurovascular 2-tip marker microcatheters (min. internal diameter
0.41 mm [0.016 in], max. internal diameter 0.48 mm [0.019 in])
• Stryker Neurovascular 0.25 mm (0.010 in) or 0.36 mm (0.014 in) or 0.41 mm
(0.016 in) steerable guidewire

7.2 Pre-procedure

Endovascular embolization should be done in an angiography procedure room. High
quality, digital subtraction fluoroscopic road mapping is mandatory to achieve safe
catheterization of the aneurysm or vessel and correct placement of the coils.
Detachment System units needed to
®

7.3 Preparation

warning: The safety and performance characteristics of the Target Detachable
Coil System (Target Detachable Coils, InZone Detachment Systems, delivery
systems and accessories) have not been demonstrated with other manufacturer's
devices (whether coils, coil delivery devices, coil detachment systems, catheters,
guidewires, and/or other accessories). Due to the potential incompatibility of non
Stryker Neurovascular devices with the Target Detachable Coil System, the use
of other manufacturer's device(s) with the Target Detachable Coil System is not
recommended.
7.3.1 Coil size & Microcatheter selection
Correct coil size increases Target Detachable Coil effectiveness and patient safety.
Occlusive efficiency is, in part, a function of compactness and overall mass. In
order to choose the appropriate coil size for a lesion, examine pre-embolization
angiograms. The appropriate coil size should be chosen based upon angiographic
assessment of the diameter of the vessel, aneurysm dome and/or ostium.
warning: To reduce risk of coil migration, the diameter of the first and second
coil should never be less than the width of the ostium.

7.3.2 Continuous flush setup

warning: In order to achieve optimal performance of the Target Detachable Coil
System and to reduce the risk of thromboembolic complications, it is critical that
a continuous infusion of appropriate flush solution be maintained between a)
the femoral sheath and guiding catheter, b) the 2-tip microcatheter and guiding
catheters, and c) the 2-tip microcatheter and Stryker Neurovascular guidewire
and delivery wire. Continuous flush also reduces the potential for thrombus
formation on, and crystallization of infusate around, the detachment zone of the
Target Detachable Coil.
1. Attach an RHV to the hub of the guiding catheter. Attach a 3-way stopcock
to the side arm of the RHV and then connect a line for continuous infusion of
appropriate solution.
2. Attach a second RHV to the hub of the 2-tip microcatheter. Attach a
1-way stopcock to the side arm of the RHV and then connect a line for
continuous flushing of appropriate solution. One drop from the pressure
bag every 3-5 seconds through an empty microcatheter is suggested.
3. Check that all fittings are secure so that air is not introduced into the guiding
catheter or 2-tip microcatheter during continuous flush.
Prior to starting the procedure, confirm that there are enough InZone Detachment
System units to complete the case plus one backup unit.
5
Black (K) ∆E ≤5.0