Cautions; Magnetic Resonance Imaging (Mri) Safety Information; Adverse Events - Stryker Target Gebrauchsanweisung

• Verify there is no movement of the coil after coil placement and prior to coil
detachment. Movement of the coil after coil placement may indicate that the
coil could migrate once it is detached.
• Failure to properly close the RHV compression fitting over the delivery
wire before attaching the InZone
movement, aneurysm rupture or vessel perforation.
• Verify repeatedly that the distal shaft of the catheter is not under stress before
detaching the Target Detachable Coil. Axial compression or tension forces
®
could be stored in the 2-tip microcatheter causing the tip to move during coil
delivery. Microcatheter tip movement could cause the aneurysm or vessel to
rupture.
• Advancing the delivery wire beyond the microcatheter tip once the coil has
been detached involves risk of aneurysm or vessel perforation.
• The long term effect of this product on extravascular tissues has not
been established so care should be taken to retain this device in the
intravascular space.

5. CaUTIons

• Besides the number of InZone Detachment System units needed to complete
the case, there must be an extra InZone Detachment System unit as back up.
• Removing the delivery wire without grasping the introducer sheath and delivery
wire together (Figure 3) may result in the detachable coil sliding out of the
introducer sheath.
• Failure to remove the introducer sheath after inserting the delivery wire into
the RHV of the microcatheter will interrupt normal infusion of flush solution
and allow back flow of blood into the microcatheter.
• Some low level overhead light near or adjacent to the patient is required to
visualize the fluoro-saver marker; monitor light alone will not allow sufficient
visualization of the fluoro-saver marker.
• Advance and retract the Target Detachable Coil carefully and smoothly
without excessive force. If unusual friction is noticed, slowly withdraw the
Target Detachable Coil and examine for damage. If damage is present, remove
and use a new Target Detachable Coil. If friction or resistance is still noted,
carefully remove the Target Detachable Coil and microcatheter and examine
the microcatheter for damage.
• If it is necessary to reposition the Target Detachable Coil, verify under
fluoroscopy that the coil moves with a one-to-one motion. If the coil does not
move with a one-to-one motion or movement is difficult, the coil may have
stretched and could possibly migrate or break. Gently remove both the coil
and microcatheter and replace with new devices.
• Increased detachment times may occur when:
• Other embolic agents are present.
• Delivery wire and microcatheter markers are not properly aligned.
• Thrombus is present on the coil detachment zone.
• Do not use detachment systems other than the InZone Detachment System,
M00345100950.
Black (K) ∆E ≤5.0
Detachment System could result in coil
®

5.1 Magnetic resonance Imaging (MrI) safety Information

(neurovascular Use)
Non-clinical testing and analysis have demonstrated the Target Detachable Coils
are MR Conditional. A patient with this device can be safely scanned immediately
after placement of the coils in an MR system meeting the following conditions:
• Static magnetic field of 3.0 T or less
• Maximum spatial gradient magnetic field of 2500 gauss/cm (25 T/m)
• Maximum MR system reported, head specific absorption rate (SAR) < 3.2 W/kg
and whole body averaged SAR < 2 W/kg (Normal operating mode)
Under the scan conditions defined above, the Target Detachable Coils are
expected to produce a maximum temperature rise of less than or equal to 4ºC
after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends
approximately 12 mm from the Target Detachable Coils when imaged with a
gradient echo pulse sequence and a 3.0 T MRI system.
Target Detachable Coils are made from non-magnetic platinum-tungsten alloy and
should not migrate in the magnetic field. The health state of the patient or the
presence of other implants may require reduction of the MRI limits.
Magnetic resonance Imaging (MrI) safety Information
(Peripheral Use)
Non-clinical testing and analysis have demonstrated the Target Detachable Coils
are MR Conditional. A patient with this device can be safely scanned immediately
after placement of the coils in an MR system meeting the following conditions:
• Static magnetic field of 3.0 T or less
• Maximum spatial gradient magnetic field of 2500 gauss/cm (25 T/m)
• Maximum MR system reported, head specific absorption rate (SAR) < 3.2 W/kg
and whole body averaged SAR < 1 W/kg (Normal operating mode)
Under the scan conditions defined above, the Target Detachable Coils are
expected to produce a maximum temperature rise of less than 7.4ºC after
15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends
approximately 13 mm from the Target Detachable Coils when imaged with a
gradient echo pulse sequence and a 3.0 T MRI system.
Target Detachable Coils are made from non-magnetic platinum-tungsten alloy and
should not migrate in the magnetic field. The health state of the patient or the
presence of other implants may require reduction of the MRI limits.

6. aDVerse eVenTs

Potential complications include, but are not limited to:
• Allergic Reaction
• Aneurysm perforation and rupture
• Arrhythmia
• Death
• Edema
• Embolus
• Headache
• Hemorrhage
• Infection
4