Warning; Device Description; Intended Use/Indications For Use; Contraindications - Stryker Target Gebrauchsanweisung

Target
®
Detachable Coil
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a
physician.
Carefully read all instructions prior to use. observe all warnings and cautions
noted throughout these instructions. failure to do so may result in complications.

warnInG

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile
barrier is damaged. If damage is found, call your Stryker Neurovascular representative.
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing
or resterilization may compromise the structural integrity of the device and/or
lead to device failure which, in turn, may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk of contamination of
the device and/or cause patient infection or cross-infection, including, but not
limited to, the transmission of infectious disease(s) from one patient to another.
Contamination of the device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance with hospital,
administrative and/or local government policy.

1. DeVICe DesCrIPTIon

Target Detachable Coils are stretch resistant, electrolytically detachable coils
consisting of a platinum-tungsten alloy coil attached to a stainless steel delivery
wire.
Target Detachable Coils are specifically designed for use with Stryker
Neurovascular's InZone Detachment System, M00345100950 (sold separately).
®
Target Detachable Coils are compatible with Stryker Neurovascular 2-tip marker
microcatheters (min. internal diameter 0.41 mm [0.016 in], max. internal diameter
0.48 mm [0.019 in]).

2. InTenDeD Use/InDICaTIons for Use

Target Detachable Coils are intended to endovascularly obstruct or occlude blood
flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable Coils are indicated for endovascular embolization of:
• Intracranial aneurysms
• Other neurovascular abnormalities such as arteriovenous malformations and
arteriovenous fistulae
• Arterial and venous embolizations in the peripheral vasculature

3. ConTraInDICaTIons

None known.

4. warnInGs

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.
• Patients with hypersensitivity to 316LVM stainless steel may suffer an allergic
reaction to this implant.
• MR temperature testing was not conducted in arteriovenous malformations or
fistulae models.
• 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.
• To reduce risk of coil migration, the diameter of the first and second coil
should never be less than the width of the ostium.
• 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.
• Do not use the product after the "Use By" date specified on the package.
• Reuse of the packaging hoop or use with any coil other than the original coil
may result in contamination of, or damage to, the coil.
• Damaged delivery wires may cause detachment failures, vessel injury or
unpredictable distal tip response during coil deployment. If a delivery wire is
damaged at any point during the procedure, do not attempt to straighten or
otherwise repair it. Do not proceed with deployment or detachment. Remove
the entire coil and replace with undamaged product.
• Utilization of damaged coils may affect coil delivery to, and stability inside,
the vessel or aneurysm, possibly resulting in coil migration and/or stretching.
• The fluoro-saver marker is designed for use with a Rotating Hemostatic Valve
(RHV). If used without an RHV, the distal end of the coil may be beyond the
alignment marker when the fluoro-saver marker reaches the microcatheter hub.
• If the fluoro-saver marker is not visible, do not advance the coil without
fluoroscopy.
• Do not rotate delivery wire during or after delivery of the coil. Rotating the
Target Detachable Coil delivery wire may result in a stretched coil or premature
detachment of the coil from the delivery wire, which could result in coil migration.
• Verify there is no coil loop protrusion into the parent vessel after coil
placement and prior to coil detachment. Coil loop protrusion after coil
placement may result in thromboembolic events if the coil is detached.
3
Black (K) ∆E ≤5.0