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Instructions for Use
Pipeline™ Flex Embolization Device
with Shield Technology™
CAUTION
•
This device should be used only by physicians trained in percutaneous,
intravascular techniques and procedures at medical facilities with the appropriate
fluoroscopic equipment...
•
The Pipeline™ Flex embolization device with Shield Technology™ should be used by
physicians who have received appropriate training for this device...
•
Carefully inspect the sterile package and the Pipeline™ Flex embolization device
with Shield Technology™ prior to use to verify that neither has been damaged during
shipment... Do not use kinked or damaged components...
•
The Pipeline™ Flex embolization device with Shield Technology™ is not to be used after
the expiration date imprinted on the product label...
•
Do not reprocess or resterilize... Reprocessing and resterilization increase the risks of
patient infection and may compromise device performance...
DESCRIPTION
The Pipeline™ Flex embolization device with Shield Technology™ consists of a permanent
implant combined with a guide-wire-based delivery system... The Pipeline™ Flex
embolization device with Shield Technology™ implant is a braided, multi-alloy, mesh
cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires... A
photograph of Pipeline™ Flex embolization device with Shield Technology™ is shown in
Figure 1a and the design of the distal delivery system is shown in Figure 1b... The woven
wires of the device provide approximately 30% metal coverage of the arterial wall surface
area... The implant is designed for placement in a parent vessel across the neck of an
intracranial aneurysm (IA)... The expanded or un-constrained diameter is 0... 2 5 mm larger
than the labeled diameter...
Shield Technology™ is a synthetic polymer surface treatment and is not derived from any
animal or human sources...
The tip coil is made of platinum-tungsten alloy, the proximal bumper is platinum-iridium
alloy, and the tip, distal and proximal solder joints are composed of tin-silver... The protective
sleeves are designed to protect the distal portion of the braid while the Pipeline™ Flex
embolization device with Shield Technology™ is advanced through the micro catheter...
The proximal bumper and resheathing pad allow the user to push the Pipeline™ Flex
embolization device with Shield Technology™ out of the micro catheter when the delivery
system is advanced... The resheathing pad also allows the user to resheath the Pipeline™ Flex
embolization device with Shield Technology™ back into the micro catheter... The resheathing
marker provides the user fluoroscopic visualization for the limit of resheathing the Pipeline™
Flex embolization device with Shield Technology™...
The Pipeline™ Flex embolization device with Shield Technology™ implant is mounted on
a 304 stainless steel micro guide-wire approximately 200 cm long and compressed inside
an introducer sheath... The Pipeline™ Flex embolization device with Shield Technology™ is
designed to be delivered only through a compatible micro catheter of 0... 0 27 inch (0... 6 9 mm)
inside diameter at least 135 cm in length...
Figure 1a: The Pipeline™ Flex embolization device with
Shield Technology™
Figure 1b: The Pipeline™ Flex embolization device with
Shield Technology™
≈200cm (Total Length)
≈125cm (Tip Coil to Fluorosafe)
15 mm
4
8
1
7
3
9
10
3 mm (Covered by Braid)
1... Tip Coil
5... Fluorosafe Marker
2... Proximal Bumper
6... Delivery Wire
3... Introducer Sheath
7... Distal Marker
4... Braid
8... PTFE Sleeves
4
INDICATIONS FOR USE
EN
The Pipeline™ Flex embolization device with Shield Technology™ is intended for endovascular
embolization of cerebral aneurysms...
CONTRAINDICATIONS
•
Patients who have not received antiplatelet agents prior to the procedure...
•
Patients with active bacterial infection...
•
Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated...
•
The Pipeline™ Flex embolization device with Shield Technology™ should not be used
alone as sole therapy for acutely ruptured aneurysms...
POTENTIAL COMPLICATIONS
Potential complications include, but are not limited to, the following:
•
Adverse reaction to antiplatelet/
anticoagulation agents or contrast
media
•
Ischemia
•
Blindness
•
Mass effect
•
Coma
•
Neurological deficits
•
Death
•
Parent Artery Stenosis
•
Device fracture
•
Perforation
•
Device migration or misplacement
•
Perforator occlusion
•
Dissection of the parent artery
•
Post-procedure bleeding
•
Distal embolization including to a
previously uninvolved territory
•
Ruptured or perforated aneurysm
•
Embolism
•
Seizure
PRECAUTIONS
•
Do not use in patients in whom the angiography demonstrates the anatomy is not
appropriate for endovascular treatment, due to conditions such as severe intracranial
vessel tortuosity or stenosis...
•
Do not attempt to re-position the Pipeline™ Flex embolization device with
Shield Technology™ after deployment past the resheathing marker...
•
Placement of multiple Pipeline™ Flex embolization devices with Shield Technology™
may increase the risk of ischemic complications...
•
The appropriate anti-platelet and anti-coagulation therapy should be administered in
accordance with standard medical practice...
•
A thrombosed aneurysm may aggravate pre-existing, or cause new, symptoms of mass
effect and may require medical therapy...
•
Do not place the Pipeline™ Flex embolization device with Shield Technology™ in
patients whom a pre-existing stent is in place in the parent artery at the target
aneurysm location...
•
Use of implants with labeled diameter larger than the parent vessel diameter may
result in decreased effectiveness and additional safety risks due to incomplete
foreshortening resulting in an implant longer than anticipated...
•
Person with known allergy to cobalt/chromium alloy (including major elements of
cobalt, chromium, nickel, molybdenum or tungsten) may suffer an allergic reaction to
the Pipeline™ Flex embolization device with Shield Technology™ implant...
•
Person with known allergy to tin, silver, stainless steel or silicone elastomer may suffer
an allergic reaction to the Pipeline™ Flex embolization device with Shield Technology™
delivery system...
COMPATIBILITY
The Pipeline™ Flex embolization device with Shield Technology™ is designed to be delivered
through a compatible 0... 0 27 (0... 6 9 mm) inside diameter micro catheter... Unconstrained diameter
of the Pipeline™ Flex embolization device with Shield Technology™ is 0... 2 5 mm greater than the
labeled diameter (on the packaging)... Do not use the Pipeline™ Flex embolization device with
Shield Technology™ in vessel diameters that are larger than the labeled diameter...
MAGNETIC RESONANCE IMAGING
Non-clinical testing has demonstrated that the Pipeline™ Flex embolization device with
Shield Technology™ is MR Conditional... It can be scanned safely under the following
conditions:
•
Static magnetic field of 3 Tesla or less...
•
Spatial gradient field of 720 Gauss/cm or less...
•
Maximum whole-body-averaged specific absorption rate (SAR) of 4... 0 W/kg for
15 minutes of scanning
6
In non-clinical testing, the Pipeline™ Flex embolization device with Shield Technology™
produced a temperature rise of less than 0... 6 °C at a maximum whole body averaged
specific absorption rate (SAR) of 4... 0 W/kg assessed by calorimetry for 15 minutes of MR
5
2
scanning in a 3 Tesla MR 750 GE Signa 20... 0 System MR Scanner...
The Pipeline™ Flex embolization device with Shield Technology™ may create local field
inhomogeneity and susceptibility artifacts which may degrade the diagnostic quality of the
MRI images... Based on the non-clinical testing of the 5... 0 mm device using standard views, the
worst case maximum artifact was < 4 mm when subjected to 3... 0 Tesla... Local field artifact
from the Pipeline™ Flex embolization device with Shield Technology™ may decrease the
accuracy of MR angiogram in assessing vessel luminal patency...
9... Resheathing Pad
MR image quality may be compromised if the area is in the exact same area or relatively
10... Resheathing Marker
close to the position of the Pipeline™ Flex embolization device with Shield Technology™...
Therefore, it may be necessary to optimize MR imaging parameters for the presence of this
metallic implant...
DIRECTIONS FOR USE
1...
2...
•
Groin injury
•
Stroke
•
Headache
•
Thromboembolism
•
Hemorrhage
•
Transient Ischemic Attack (TIA)
3...
•
Hematoma or hemorrhage at the
puncture site
•
Vasospasm
4...
•
Hydrocephalus
•
Vessel occlusion
5...
•
Infection
6...
•
Vessel perforation
•
Intracerebral bleeding
•
Vision impairment
•
Chronic pain
7...
•
AV fistula
•
Pseudoaneurysm
8...
9...
10...
11...
12...
13...
WARNING
Pushing delivery wire without retracting the micro catheter at the same time will cause
the open end braid to move distally in the vessel... This may cause damage to the braid
or vessel
14...
15...
Using standard interventional radiographic technique, place the micro catheter
tip at least 20 mm past the distal edge of the aneurysm... Gently retract the micro
catheter to reduce slack in the micro catheter prior to inserting Pipeline™ Flex
embolization device with Shield Technology™...
Note: It is recommended to use a heparinized saline drip to continuously flush micro
catheter during Pipeline™ Flex embolization device with Shield Technology™ use...
Choose a Pipeline™ Flex embolization device with Shield Technology™ with labeled
diameter that approximates the target vessel diameter...
•
Select an appropriately sized Pipeline™ Flex embolization device with
Shield Technology™ such that its fully expanded diameter is equivalent to that
of the largest target vessel... An incorrectly sized Pipeline™ Flex embolization
device with Shield Technology™ may result in inadequate device placement,
incomplete opening, or migration...
•
The Pipeline™ Flex embolization device with Shield Technology™ foreshortens
substantially (50-60%) during deployment... Take device foreshortening
into account when deploying the Pipeline™ Flex embolization device with
Shield Technology™...
Choose a Pipeline™ Flex embolization device with Shield Technology™ with labeled
length that is at least 6 mm longer than the aneurysm neck...
Remove packaging hoop from the pouch and pull the distal end of the introducer
sheath from the blue clip on the packaging hoop...
Carefully remove system from packaging hoop until the delivery wire is exposed...
Partially insert introducer sheath into the rotating hemostatic valve (RHV) at the
catheter hub and close the RHV... Confirm back flush of the heparinized saline at
the proximal end of the introducer sheath prior to advancing the Pipeline™ Flex
embolization device with Shield Technology™ into the micro catheter...
Advance introducer sheath into the RHV; visually confirm the tip of the sheath is
seated deeply in the hub of the micro catheter...
Secure introducer sheath to the hub by locking down the RHV tightly...
Advance the proximal end of delivery wire until it aligns with proximal end of
introducer sheath...
Remove the introducer sheath...
Note: The delivery wire has a fluorosafe marker no further than 125 cm from the
distal end...
Caution: The fluorosafe marker is only compatible with micro catheters with a
minimum length of 135 cm...
Advance the Pipeline™ Flex embolization device with Shield Technology™ into the
micro catheter by pushing the delivery wire until the tip of the delivery wire aligns
with the tip of the micro catheter...
Caution: If high forces or excessive friction is encountered during delivery, discontinue
delivery of the device and identify the cause of the resistance, remove device and
micro catheter simultaneously... Advancement of the Pipeline™ Flex embolization
device with Shield Technology™ against resistance may result in damage or patient
injury...
Caution: The presence of other indwelling endovascular stents may interfere with
proper deployment and function of the Pipeline™ Flex embolization device with
Shield Technology™...
Once the tip of delivery system and micro catheter are aligned, verify that
the Pipeline™ Flex embolization device with Shield Technology™ is in the
desired location... Distal end of Pipeline™ Flex embolization device with
Shield Technology™ should be placed at least 3 mm past the distal edge of the
aneurysm...
Begin to deliver the Pipeline™ Flex embolization device with Shield Technology™
using a combination of unsheathing the Pipeline™ Flex embolization device with
Shield Technology™ and pushing the delivery wire simultaneously...
After the distal end of the Pipeline™ Flex embolization device with Shield Technology™
has successfully expanded, deploy the remainder of Pipeline™ Flex embolization
device with Shield Technology™ by pushing the delivery wire and/or unsheathing
the Pipeline™ Flex embolization device with Shield Technology™... Resheathing and/
or manipulation of the micro catheter, by locking down the delivery wire and moving
both as a system, may facilitate expansion of the Pipeline™ Flex embolization device
with Shield Technology™...
Caution: Under fluoroscopy, carefully monitor the tip coil during Pipeline™ Flex
embolization device with Shield Technology™ deployment...
Caution: If the delivery wire cannot be retracted into the micro catheter, carefully
remove the delivery wire and micro catheter simultaneously...
Resheathing Instructions: During deployment of the Pipeline™ Flex embolization
device with Shield Technology™ resheathing can be performed by advancing the micro
catheter while pulling delivery wire...
•
The Pipeline™ Flex embolization device with Shield Technology™ can be
resheathed until the resheathing marker has reached the distal marker of the
micro catheter (see Figure 2 below)...
•
The Pipeline™ Flex embolization device with Shield Technology™ is fully
resheathed when the distal marker is retracted completely inside the micro
catheter... The system is designed to allow for 2 full cycles of resheathing of the
Pipeline™ Flex embolization device with Shield Technology™...
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