ENGLISH: INSTRUCTIONS FOR USE
Trevo
®
XP ProVue Retriever (4x30mm)
PK50965-020/A/6294, 2015-04, 1 / 40
Concentric
Medical
®
Manufacturer European
Authorized
Representative
Concentric Medical, Inc.
301 East Evelyn Avenue
Mountain View, CA 94041
USA
650 938 2100
877 471 0075 (USA)
Fax: 650 938 2700
EMERGO EUROPE
Molenstraat 15
2513 BH, The Hague
The Netherlands
Device Description
The Retriever consists of a flexible, tapered core wire with a shaped section at the distal
end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the
shaped section is also radiopaque. Retriever dimensions are indicated on product label.
The Retriever has a hydrophilic coating to reduce friction during use. The Retriever has
a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A torque
device is provided with the Retriever to facilitate manipulation. The torque device is
used to lock the core wire to the microcatheter during the procedure. Locking of the
torque device to the wire allows the microcatheter and Retriever to be retracted as a
system during clot retrieval. An insertion tool is provided to introduce the Retriever into a
Microcatheter. The Insertion Tool is a sheath in which the Retriever comes preloaded.
Once half the retriever’s length is inserted into the microcatheter, the insertion tool is
removed. Retrievers have a modified proximal end that permits attachment of the
Abbott Vascular DOC Guide Wire Extension (REF 22260). Joining Guide Wire
Extension to Retriever facilitates removal or exchange of a catheter while maintaining
Retriever position in anatomy. After exchange has been completed, the extension can
be detached.
Indications for Use
The Trevo
®
Retriever is intended to restore blood flow in the neurovasculature by
removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom
onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA)
or who fail IV t-PA therapy are candidates for treatment.
Complications
Procedures requiring percutaneous catheter introduction should not be attempted by
physicians unfamiliar with possible complications which may occur during or after the
procedure. Possible complications include, but are not limited to, the following: air
embolism; hematoma or hemorrhage at puncture site; infection; distal embolization;
pain/headache; vessel spasm, thrombosis, dissection, or perforation; emboli; acute
occlusion; ischemia; intracranial hemorrhage; false aneurysm formation; neurological
deficits including stroke; and death.
Compatibility
4x30mm Retrievers are compatible with Trevo Pro 18 (REF 90238) and Excelsior
®
XT-
27
®
Microcatheters (150cm x 6cm straight REF 275081). Compatibility of the Retriever
with other microcatheters has not been established. Performance of the Retriever
device may be impacted if a different microcatheter is used.
Balloon Guide Catheters (such as the Merci
®
Balloon Guide Catheter and the
FlowGate
®
Balloon Guide Catheter) are recommended for use during thrombus removal
procedures.
Retrievers are compatible with Boston Scientific Rotating Hemostatic Value (REF
421242).
Retrievers are compatible with the Abbott Vascular DOC Guide Wire Extension
(REF 22260).
Warnings
•
Contents supplied STERILE using an ethylene oxide (EO) process. Nonpyrogenic.
•
To reduce risk of vessel damage, adhere to the following recommendations:
−
Take care to appropriately size Retriever to vessel diameter at intended site of
deployment.
−
Do not perform more than six (6) retrieval attempts in same vessel using
Retriever devices.
−
Maintain Retriever position in vessel when removing or exchanging
Microcatheter.
•
To reduce risk of kinking/fracture, adhere to the following recommendations:
−
Immediately after unsheathing Retriever, position Microcatheter tip marker just
proximal to shaped section. Maintain Microcatheter tip marker just proximal to
shaped section of Retriever during manipulation and withdrawal.
−
Do not rotate or torque Retriever.
−
Use caution when passing Retriever through stented arteries.
•
Do not resterilize and reuse. Structural integrity and/or function may be impaired by
reuse or cleaning.
•
The Retriever is a delicate instrument and should be handled carefully. Before use
and when possible during procedure, inspect device carefully for damage. Do not
use a device that shows signs of damage. Damage may prevent device from
functioning and may cause complications.
•
Do not advance or withdraw Retriever against resistance or significant vasospasm.
Moving or torquing device against resistance or significant vasospasm may result in
damage to vessel or device. Assess cause of resistance using fluoroscopy and if
needed resheath the device to withdraw.
•
If Retriever is difficult to withdraw from the vessel, do not torque Retriever. Advance
Microcatheter distally, gently pull Retriever back into Microcatheter, and remove
Retriever and Microcatheter as a unit. If undue resistance is met when withdrawing
the Retriever into the Microcatheter, consider extending the Retriever using the
Abbott Vascular DOC guidewire extension (REF 22260) so that the Microcatheter
can be exchanged for a larger diameter catheter such as a DAC
®
Catheter. Gently
withdraw the Retriever into the larger diameter catheter.
•
Administer anti-coagulation and anti-platelet medications per standard institutional
guidelines.
Precautions
•
Prescription only – device restricted to use by or on order of a physician.
•
Store in cool, dry, dark place.
•
Do not use open or damaged packages.
•
Use by “Use By” date.
•
Exposure to temperatures above 54°C (130°F) may damage device and
accessories. Do not autoclave.
•
Do not expose Retriever to solvents.
•
Use Retriever in conjunction with fluoroscopic visualization and proper anti-
coagulation agents.
•
To prevent thrombus formation and contrast media crystal formation, maintain a
constant infusion of appropriate flush solution between guide catheter and
Microcatheter and between Microcatheter and Retriever or guidewire.
•
Do not attach a torque device to the shaped proximal end of DOC Compatible
Retriever. Damage may occur, preventing ability to attach DOC Guide Wire
Extension.
Recommended Preparation Procedure
1. Flush Retriever package hoop with saline. Hydrate for 2 minutes minimum before
removing Retriever from hoop. Keep Retriever hydrated.
2. Prepare and place Balloon Guide Catheter or Guide Catheter into internal carotid
artery, common carotid artery or subclavian artery as specified in guide catheter
labeling.
3. Connect rotating hemostasis valve to Microcatheter hub.
4. Using conventional catheterization techniques, place Microcatheter into target
vessel using a standard neurovascular guidewire. Anatomy permitting, position
Microcatheter tip distal to thrombus.
5. Remove guidewire from Microcatheter. Inject contrast media through Microcatheter
to visualize distal vasculature. Flush Microcatheter.
6. Remove insertion tool and preloaded Retriever as a unit from package hoop. Do
not allow Retriever to exit insertion tool tip or to retract further into insertion tool.
7.
Important:
Introduce insertion tool half way into the rotating hemostasis valve and
use syringe or infusion line to flush insertion tool until saline exits the proximal end
of the insertion tool. If insertion tool is not properly flushed, it may be difficult to
advance the Retriever through the insertion tool.
8. Seat insertion tool into Microcatheter hub and close rotating hemostasis valve
tightly to secure insertion tool in place.
9. Advance Retriever until half of its length has been inserted into Microcatheter.
Remove insertion tool.
Recommended Retrieval Procedure
1. Advance Retriever until distal tip aligns with tip of Microcatheter.
Note: Retriever tip will be within 15 cm of exiting Microcatheter tip when (a) distal
end of Retriever shaft marker reaches Microcatheter hub, or (b) proximal end of
Retriever shaft marker reaches proximal end of rotating hemostasis valve.
2. Retract Microcatheter while applying gentle forward force to Retriever to deploy
shaped section of Retriever within clot. Position Microcatheter tip marker just
proximal to shaped section of Retriever.
WARNING: To reduce risk of kinking/fracture, maintain Microcatheter tip marker
just proximal to shaped section of Retriever during manipulation and withdrawal.
3. After deploying Retriever, visualize strut expansion and allow sufficient time for clot
to integrate into the Retriever (approximately 5 minutes).
4. If using a Balloon Guide Catheter, inflate balloon to occlude vessel as specified in
Balloon Guide Catheter labeling.
5. Position and lock torque device onto Retriever at Microcatheter hub.
6. Slowly withdraw Retriever and Microcatheter as a unit to Balloon Guide Catheter tip
while applying aspiration to Balloon Guide Catheter using 60 mL syringe.
7. Apply vigorous aspiration to Balloon Guide Catheter using 60 mL syringe and
withdraw Retriever and Microcatheter inside guide catheter. Continue aspirating
until Retriever and Microcatheter are nearly withdrawn from guide catheter.
Note: If withdrawal into Balloon Guide Catheter or Guide Catheter is difficult, deflate
Balloon Guide Catheter balloon and simultaneously withdraw guide catheter,
Microcatheter and Retriever as a unit through sheath. Remove sheath if necessary.
8. Deflate Balloon Guide Catheter balloon.
9. Disconnect Balloon Guide Catheter rotating hemostasis valve and fully remove
Retriever, Microcatheter and rotating hemostasis valve as a unit from guide
catheter.
10. Attach 60 mL syringe to Balloon Guide Catheter hub and aspirate.
11. Clean the device with saline. Inspect Retriever for damage. Do not reuse Retriever
if core wire, shaped section or platinum coil appears different than when first
removed from package. If not damaged, the Retriever may be used for up to three
