English - Medtronic Solitaire X SFR4-4-20-05 Gebrauchsanweisung

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Instructions for Use
Solitaire X Revascularization Device
™
PRECAUTIONS
• The Solitaire™ X Revascularization Device should only be used by physicians trained in interventional neuroradiology
and treatment of ischemic stroke.
• Operators should take all necessary precautions to limit X-ray radiation doses to patients and themselves by using
sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors whenever possible.
• Carefully inspect the sterile package and the Solitaire™ X Revascularization Device prior to use to verify that neither
has been damaged during shipment. Do not use kinked or damaged components.
• The Solitaire™ X Revascularization Device is not to be used after the expiration date imprinted on the product label.
• Refer to the appropriate intravenous tissue plasminogen activator (IV t-PA) manufacturer labeling for indications,
contraindications, warnings, precautions, and instructions for use.
• Initiate mechanical thrombectomy treatment as soon as possible.
DESCRIPTION
The Solitaire™ X Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to
large intracranial vessel occlusion. The device is designed for use in the neurovasculature such as the internal carotid artery,
M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries.
Solitaire™ X Revascularization Device
4
5 3
1
1. Proximal marker
2. Distal markers
3. Introducer sheath
4. Push wire
5. Fluorosafe marker
INDICATIONS
The Solitaire™ X Revascularization Device is designed for use in the flow restoration of patients with ischemic stroke due to
large intracranial vessel occlusion. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who
fail IV t-PA therapy are candidates for treatment.
Recommended
Model Vessel Diameter
(mm)
min.
SFR4-4-20-05
2.0
SFR4-4-20-10
2.0
SFR4-4-40-10
2.0
SFR4-6-20-10
2.0
SFR4-6-24-06
2.0
SFR4-6-40-10
2.0
1 Select a Solitaire™ X Revascularization Device based on the sizing recommendations in Table 1 and based on the smallest vessel diameter at thrombus site.
Select a Solitaire™ X Revascularization Device usable length that is at least as long as the length of the thrombus.
2
Figure 1:
A. Stent diameter
B. Usable length
C. Stent length
D. Length from distal tip to fluorosafe marker
E. Marker to marker length
Product Specifications and Recommended Sizing Guidelines
Recommended
1
Microcatheter ID (Inch)
max. min. max.
4.0 0.021 0.027
4.0 0.021 0.027
4.0 0.021 0.027
5.5 0.021 0.027
5.5 0.021 0.027
5.5 0.021 0.027
The Solitaire™ X Revascularization Device should only be used by physicians trained in interventional neuroradiology and
en
treatment of ischemic stroke.
CONTRAINDICATIONS
Use of the Solitaire™ X Revascularization Device is contraindicated under these circumstances.
• Patients with known hypersensitivity to nickel-titanium.
• Patients with stenosis and/or pre-existing stent proximal to the thrombus site that may preclude safe recovery of the
Solitaire™ X Revascularization Device.
• Patients with angiographic evidence of carotid dissection.
POTENTIAL COMPLICATIONS
Possible complications include, but are not limited to the following:
• Adverse reaction to antiplatelet/ anticoagulation
agents or contrast media
• Air Embolism
• Allergic reactions
• Arteriovenous Fistula
• Brain Edema
• Change in mental status
• Device(s) deformation, collapse, fracture or
malfunction
• Distal embolization including to a previously
uninvolved territory
• Hematoma and hemorrhage at puncture site
• Infection
• Inflammation
• Intracranial Hemorrhage
• Ischemia
WARNINGS
• The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard
medical practice.
2
• Administer IV t-PA as soon as possible for all patients who are indicated to receive the drug. Do not cause delays
in this therapy.
• Do not torque the Solitaire™ X Revascularization Device.
• For vessel safety, do not perform more than three recovery attempts in the same vessel using Solitaire™ X
Revascularization Devices.
• For device safety, do not use each Solitaire™ X Revascularization Device for more than three flow restoration
recoveries.
• For each new Solitaire™ X Revascularization Device, use a new microcatheter.
• Solitaire™ X Revascularization Device does not allow for electrolytic detachment.
Table 1.
Solitaire™ X Revascularization Device:
Push Wire Stent Usable
Length Diameter Length
(cm) (mm) (mm)
200 4.0 20.0
200 4.0 20.0
200 4.0 40.0
200 6.0 20.0
200 6.0 24.0
200 6.0 40.0
4
•
•
•
•
•
•
•
•
•
Length from
Stent Distal tip to
Length fluorosafe
2
marker
(mm) (cm)
31.0 <130
31.0 <130
50.0 <130
31.0 <130
37.0 <130
47.0 <130
Neurologic deterioration including stroke
progression, stroke in new vascular territory, and
death
Perforation or dissection of the vessel
Persistent neurological deficits
Post procedure bleeding
Pseudo aneurysm formation
The risk of complication of radiation exposure
(e.g., alopecia, burns ranging in severity from
skin reddening to ulcers, cataracts, and delayed
neoplasia) increases as the procedure time and the
number of procedures increase
Thrombosis (acute and subacute)
Vascular occlusion
Vasoconstriction (Vasospasm)
Radiopaque
Radiopaque
Stent Markers
Markers
Spacing
Distal Prox. (mm)
3 1 5
3 1 10
3 1 10
4 1 10
4 1 6
4 1 10