Medtronic PED-275-10 Instructions for Use
INSTRUCTIONS FOR USE
Pipeline™ Flex Embolization Device
TABLE OF CONTENTS
Pipeline™ Flex Embolization Device
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Instructions for Use
Pipeline™ Flex Embolization Device
INDICATIONS FOR USE
The Pipeline™ Flex embolization device is indicated for the endovascular treatment of adults (22 years of age
or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the
petrous to the superior hypophyseal segments.
The Pipeline™ Flex embolization device is also indicated for use in the internal carotid artery up to the
terminus for the endovascular treatment of adults (22 years of age or older) with small and medium widenecked (neck width ≥ 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysm (IAs)
arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm.
CONTRAINDICATIONS
• Patients with active bacterial infection.
• Patients in whom dual antiplatelet and/or anticoagulation therapy (aspirin and clopidogrel) is
contraindicated.
• Patients who have not received dual antiplatelet agents prior to the procedure.
• Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location.
• Patients in whom the parent vessel size does not fall within the indicated range.
WARNINGS
• Resheathing of the Pipeline™ Flex embolization device more than 2 full cycles may cause damage to
the distal or proximal ends of the braid.
• Persons with known allergy to platinum or cobalt/chromium alloy (including the major elements
platinum, cobalt, chromium, nickel, molybdenum or tungsten) may suer an allergic reaction to the
Pipeline™ Flex embolization device implant.
• Person with known allergy to tin, silver, stainless steel or silicone elastomer may suer an allergic
reaction to the Pipeline™ Flex embolization device delivery system.
• Do not reprocess or resterilize. Reprocessing and resterilization increase the risk of patient infection
and compromised device performance.
• Post-procedural movement (migration and/or foreshortening) of the Pipeline™ Flex Embolization
Device implant may occur following implantation and can result in serious adverse events and/or
death.
• Factors which may contribute to post procedural device movement include (but are not limited to)
the following:
• Failure to adequately size the implant (i.e., under sizing)
• Failure to obtain adequate wall apposition during the implant deployment
• Implant stretching
• Vasospasm
• Severe vessel tapering
• Tortuous anatomy
• Delayed rupture may occur with large and giant aneurysms.
• Placement of multiple Pipeline™ Flex embolization devices may increase the risk of ischemic
complications.
• Use in anatomy with severe tortuosity, stenosis or parent vessel narrowing may result in diculty
or inability to deploy the Pipeline™ Flex Embolization Device and can lead to damage to the
Pipeline™ Flex Embolization Device and microcatheter. Advancement or retraction of the Pipeline™
Flex embolization device against resistance may result in damage, including unintended device
or component separation, fracture, or breakage of the delivery system due to inherent exibility
limits of device design. Device damage may result in patient injury or death. Refer to page 4 in the
instructions for use for additional information.
• Do not attempt to reposition the device after full deployment.
• The benets may not outweigh the risks of treatment of small and medium asymptomatic extradural
intracranial aneurysms, including those located in the cavernous internal carotid artery. The risk of
rupture for small and medium asymptomatic extradural intracranial aneurysms is very low if not
negligible.
WARNINGS
• A decrease in the proportion of patients who achieve complete aneurysm occlusion without
signicant parent artery stenosis has been observed with the use of the device in the communicating
segment (C7) of the internal carotid artery (47.4% (9/19 subjects in the PREMIER study at 1 year)),
including those IAs fed by the posterior circulation or have retrograde lling. Ensure appropriate
patient selection and weigh the benets and risks of alternative treatments prior to use of this
device for the treatment of intracranial aneurysms located in this region of the ICA. The following
anatomical characteristics, associated with retrograde lling, should be carefully considered during
procedural planning of C7 intracranial aneurysms:
1. Observed PComm of fetal origin (A PCA of fetal origin is dened as a small, hypoplastic, or
absent P1 segment of the PCA with the PComm artery supplying a majority of blood ow to
the ICA);
2. PComm overlapping with the aneurysm neck; and/or
3. PComm branch arising from the dome of the aneurysm.
PRECAUTIONS
• The Pipeline™ Flex embolization device should be used only by physicians trained in percutaneous,
intravascular techniques and procedures at medical facilities with the appropriate uoroscopic
equipment.
• Physicians should undergo appropriate training prior to using the Pipeline™ Flex embolization device
in patients.
• The Pipeline™ Flex embolization device is provided sterile for single use only.
• Store in a cool, dry place.
• Carefully inspect the sterile package and device components prior to use to verify that they have not
been damaged during shipping.
• Do not use kinked or damaged components.
• Do not use product if the sterile package is damaged
• Use the Pipeline™ Flex embolization device system prior to the “Use By” date printed on the package.
• The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with
standard medical practice.
• A thrombosing aneurysm may aggravate pre-existing, or cause new, symptoms of mass eect and
may require medical therapy.
• Use of implants with labeled diameter larger than the parent vessel diameter may result in decreased
eectiveness and additional safety risk due to incomplete foreshortening resulting in an implant
longer than anticipated.
• The Pipeline™ Flex embolization device may create local eld inhomogeneity and susceptibility
artifacts during magnetic resonance angiography (MRA), which may degrade the diagnostic quality to
assess eective intracranial aneurysm treatment.
• Take all necessary precautions to limit X-radiation doses to patients and themselves by using sucient
shielding, reducing uoroscopy times, and modifying X-ray technical factors where possible.
• Carefully weigh the benets of treatment vs. the risks associated with treatment using the device for
each individual patient based on their medical health status and risks factors for intracranial aneurysm
rupture during their expected life time such as age, medical comorbidities, history of smoking,
intracranial aneurysm size, location, and morphology, family history, history of prior asymptomatic
subarachnoid hemorrhage (aSAH), documented growth of intracranial aneurysm on serial imaging,
presence of multiple intracranial aneurysms, and presence of concurrent pathology. The benets
of device use may not outweigh the risks associated with the device in certain patients; therefore,
judicious patient selection is recommended.
• The safety and eectiveness of the device has not been established for treatment of fusiform IAs.
• There may be a decrease in eectiveness and increase in safety events when the device is used in
patients ≥ 60 years old.
• The safety and eectiveness of the device has not been evaluated or demonstrated for ruptured
aneurysms.
POTENTIAL COMPLICATIONS
Potential complications of the device and the endovascular procedure include, but are not limited to, the
following:
• Adverse reaction to antiplatelet/anticoagulation agents, anesthesia, reactions due to radiation
exposure (such as alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and
delayed neoplasia) or contrast media, including organ failure
• Vascular Complications like vasospasm, stenosis, dissection, perforation, rupture, stula formation,
pseudo aneurysm, occlusion ,thromboembolic complications including ischemia (to unintended
territory)
• Device complications like fracture, breakage (including unintended device or component separation),
misplacement, migration / delayed foreshortening or reaction to device materials may occur.
• Systemic Complications like: Infection, Pain, fever, allergic reactions, organ failure, nerve damage
• Bleeding/ hemorrhagic complication including retroperitoneal hemorrhage
• Neurological Decits or dysfunctions including Stroke, Infarction, Loss of vision, Seizures, TIA,
Headache, Cranial Nerve Palsies, Confusion, Coma
3
• Decreased therapeutic response including need for target aneurysm retreatement
6
• Risks associated with visual symptoms include Amaurosisfugax/transient blindness, Blindness,
Diplopia, Reduced visual acuity/eld, Retinal artery occlusion, Retinal ischemia, Retinal infarction,
Vision impairment including scintillations, blurred vision, eye oaters
• Intra-Cranial Hemorrhage (including from Aneurysm Rupture) Brain Edema, Hydrocephalus, Mass
Eect
• Death
DESCRIPTION
The Pipeline™ Flex embolization device consists of a permanent implant combined with a guidewire based
delivery system. The Pipeline™ Flex embolization device implant is a braided, multi-alloy, mesh cylinder
woven from platinum/tungsten and cobalt-chromium-nickel alloy wires. A photograph of the Pipeline™ Flex
embolization device 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 unconstrained diameter is 0.25 mm larger than the labeled diameter.
The tip coil is made of platinum-tungsten alloy, the proximal bumper is a platinum-iridium alloy, and the
tip, distal, and proximal solder joints are tin-silver. The protective sleeves are designed to protect the distal
portion of the braid while the Pipeline™ Flex embolization device is advanced through the micro catheter.
The proximal bumper and resheathing pad allows the user to push the Pipeline™ Flex embolization device
out of the micro catheter when the delivery system is advanced. The resheathing pad allows the user to
resheath the Pipeline™ Flex embolization device back into the micro catheter. The resheathing marker
provides the user uoroscopic visualization for the limit of resheathing the Pipeline™ Flex embolization
device.
The Pipeline™ Flex embolization device implant is mounted on a 304 stainless steel micro-guidewire
approximately 200 cm long and compressed inside an introducer sheath. The Pipeline™ Flex embolization
device is designed to be delivered only through a compatible micro catheter of 0.027 inch (0.69 mm) inside
diameter at least 135 cm in length.
Figure 1a. The Pipeline™ Flex embolization device
≈200cm (Total Length)
15 mm
1 2
3
≈125cm (Tip Coil to Fluorosafe)
8
7
4
9
10
3 mm (Covered by Braid)
Figure 1b. The Pipeline™ Flex embolization device
1. Tip Coil 5. Fluorosafe Marker 9. Resheathing Pad
2. Proximal Bumper 6. Delivery Wire 10. Resheathing Marker
3. Introducer Sheath 7. Distal Marker
4. Braid 8. PTFE Sleeves
Table 1. Size Ranges: Pipeline™ Flex embolization device.
Labeled Diameter
(mm)
Self Expanded
Diameter (mm)
Labeled Lengths (mm)
2.50 2.75 10, 12, 14, 16, 18, 20
2.75 3.00 10, 12, 14, 16, 18, 20
3.00 3.25 10, 12, 14, 16, 18, 20, 25, 30, 35
3.25 3.50 10, 12, 14, 16, 18, 20, 25, 30, 35
3.50 3.75 10, 12, 14, 16, 18, 20, 25, 30, 35
3.75 4.00 10, 12, 14, 16, 18, 20, 25, 30, 35
4.00 4.25 10, 12, 14, 16, 18, 20, 25, 30, 35
4.25 4.50 10, 12, 14, 16, 18, 20, 25, 30, 35
5
Labeled Diameter
(mm)
Self Expanded
Diameter (mm)
Labeled Lengths (mm)
4.50 4.75 10, 12, 14, 16, 18, 20, 25, 30, 35
4.75 5.00 10, 12, 14, 16, 18, 20, 25, 30, 35
5.00 5.25 10, 12, 14, 16, 18, 20, 25, 30, 35
MAGNETIC RESONANCE IMAGING
Non-clinical testing has demonstrated that the Pipeline™ Flex embolization device is MR Conditional. It can
be scanned safely under the following conditions:
• Static magnetic eld of 3 Tesla or less.
• Spatial gradient eld of 720 Gauss/cm or less.
• Maximum whole-body-averaged specic absorption rate (SAR) of 4.0 W/kg for 15 minutes of
scanning.
In non-clinical testing, the Pipeline™ Flex embolization device produced a temperature rise of less than
0.6°C at a maximum whole body averaged specic absorption rate (SAR) of 4.0 W/kg for 15 minutes of MR
scanning in a 3 Tesla MR 750 GE Signa 20.0 system MR Scanner.
The Pipeline™ Flex embolization device may create local eld 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 eld artifact from the Pipeline™ Flex embolization device may decrease the accuracy of MR angiogram
in assessing vessel luminal patency.
MR image quality may be compromised if the area is in the exact same area or relatively close to the
position of the Pipeline™ Flex embolization device. Therefore, it may be necessary to optimize MR imaging
parameters for the presence of this metallic implant.
PACKAGING AND STORAGE
Store in a cool dry place.
DIRECTIONS FOR USE
1. 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.
NOTE: It is recommended to use a heparinized saline drip to continuously ush micro catheter during
Pipeline™ Flex embolization device use.
2. Choose a Pipeline™ Flex embolization device with labeled diameter that approximates the target
vessel diameter.
• Select an appropriate sized Pipeline™ Flex embolization device such that its fully expanded diameter
is equivalent to that of the largest target vessel. An incorrectly sized Pipeline™ Flex embolization
device may result in inadequate device placement, incomplete opening or migration.
• The Pipeline™ Flex embolization device foreshortens substantially (50-60%) during deployment.
Take device foreshortening into account when deploying the Pipeline™ Flex embolization device.
3. Choose a Pipeline™ Flex embolization device with labeled length that is at least 6 mm longer than the
aneurysm neck.
4. Remove packaging hoop from the pouch and pull the distal end of the introducer sheath from the blue
clip on the packaging hoop.
5. Carefully remove system from packaging hoop until the delivery wire is exposed.
6. Partially insert introducer sheath into the rotating hemostatic valve (RHV) at the catheter hub and
close the RHV. Using a ush pressure of 250mmHg or greater, conrm back ush of the saline at the
proximal end of the introducer sheath prior to advancing the Pipeline™ Flex embolization device into
the micro catheter.
7. Advance introducer sheath into the RHV; visually conrm the tip of the sheath is seated deeply in the
hub of the micro catheter.
8. Secure introducer sheath to the hub by locking down the RHV tightly.
9. Advance the proximal end of the delivery wire until it aligns with the proximal end of the introducer
sheath.
10. Remove the introducer sheath.
NOTE: The delivery wire has a uorosafe marker no further than 125 cm from the distal end.
CAUTION: The uorosafe marker is only compatible with micro catheters with a minimum length of
135 cm.
11. Advance the Pipeline™ Flex embolization device 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 or retraction of the Pipeline™ Flex embolization device against resistance may result in
4
damage, including unintended device or component separation, fracture, or breakage of the delivery
1
2
3
4 5
7
6
8
system due to inherent exibility limits of device design. Device damage may result in patient injury
or death.
CAUTION: The presence of other indwelling endovascular stents may interfere with proper
deployment and function of the Pipeline™ Flex embolization device.
12. Once the tip of delivery system and micro catheter are aligned, verify that the Pipeline™ Flex
embolization device is in the desired location. The distal end of Pipeline™ Flex embolization device
should be placed at least 3 mm past the distal edge of the aneurysm.
13. Begin to deliver the Pipeline™ Flex embolization device using a combination of unsheathing the
Pipeline™ Flex embolization device and pushing the delivery wire simultaneously.
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.
• Use in tortuous anatomy may result in diculty or inability to deploy the Pipeline™ Flex
Embolization Device and can lead to damage to the Pipeline™ Flex Embolization Device and
microcatheter. To mitigate potential problems as a result of increased delivery forces, reduce the
load in the system by:
• Unloading the microcatheter to the inner curves of vessel by pulling back on the system (i.e., the
microcatheter and delivery wire together).
• Continue unloading the system until advancement of the device (inside of microcatheter) is
observed, while minimizing the distal tip movement to prevent loss of position.
• Begin to re-advance the delivery wire while maintaining reduced load in the microcatheter. This
process should be repeated until the device passes through tortuous area and the delivery force
is decreased.
14. After the distal end of Pipeline™ Flex embolization device has successfully expanded, deploy the
remainder of Pipeline™ Flex embolization device by pushing the delivery wire and/or unsheathing the
Pipeline™ Flex embolization device. 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.
CAUTION: Under uoroscopy, carefully monitor the tip coil during Pipeline™ Flex embolization device
deployment.
15. Resheathing Instructions: During deployment of the Pipeline™ Flex embolization device resheathing
can be performed by advancing the micro catheter while pulling the delivery wire.
• The Pipeline™ Flex embolization device 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 is fully resheathed when the distal marker is retracted
completely inside the micro catheter. The system is designed to allow for a 2 full cycles of
resheathing of the Pipeline™ Flex embolization device.
WARNING
• Resheathing the Pipeline™ Flex embolization device more than 2 full cycles may cause damage to
the distal or proximal ends of the braid.
4. Resheathing Marker 8. Device Detached
16. After the entire Pipeline™ Flex embolization device is deployed, advance the micro catheter through
the device making sure not to dislodge the braid. When the micro catheter tip is distal to the Pipeline™
Flex embolization device, retract the delivery wire into the micro catheter tip.
CAUTION: If the catheter cannot be advanced through the Pipeline™ Flex embolization device,
carefully remove the delivery wire through the Pipeline™ Flex embolization device construct.
CAUTION: If the delivery wire cannot be retracted into the micro catheter, carefully remove the
delivery core wire and micro catheter simultaneously.
17. Carefully inspect the deployed Pipeline™ Flex embolization device under uoroscopy to conrm that it
is completely apposed to the vessel wall and not kinked. If the device is not fully apposed or is kinked,
consider using a balloon catheter, micro catheter, or guidewire to fully open it.
DISPOSAL: The implant and or delivery system should be disposed of or returned to the manufacturer
per institutional guidelines.
Observed Adverse Events
There were two prospective investigational trials conducted on the Pipeline™ device, the PUFs and PREMIER
studies.
PUFS was a prospective, multicenter international study of patients with large and giant wide-necked
unruptured aneurysms of the internal carotid artery treated with the Pipeline™ Embolization device (PED).
108 subjects were enrolled and treated in the PUFs study. The PUFs-CA study was also a prospective,
multicenter study of patents with large and giant unruptured aneurysms of the internal carotid artery
treated with the Pipeline™ Embolization device (PED). 27 subjects were enrolled and treated in the PUFs-CA
study. The PUFs-PAS study was a single arm-prospective, multicenter cohort study of patients implanted
with PED, the study population consisted of patients with large and giant unruptured aneurysms that were
enrolled in the PUFs-PUFs-CA studies. 135 subjects were enrolled and 134 subjects were treated in the
PUFs-PAS study. Serious adverse events reported to ve year follow-up are shown in Table 2 and non-serious
adverse events are shown in Table 3. In the PUFs-PAS study, cerebral haemorrhage was reported in 4.5%
(6/134) subjects, cerebral ischaemia was reported in 2.2% (3/134) subjects, and ischaemic stroke was
reported in 1.5% (2/134) subjects at 5 years (Table 2). Five occurred
in the peri-procedural period (prior to discharge) and 6 in the post-procedural period. Two of the events
were fatal, both intracerebral hemorrhages.
One peri-procedural ischemic stroke and 2 post-procedural ischemic strokes were associated with
parent artery occlusion.
A history of hypertension is associated with increased risk of ipsilateral stroke or neurovascular death
following PED treatment.
NOTE: The Pipeline™ Flex embolization device utilizes the same implant as the Pipeline™ embolization
device in the PUFS-PAS trial.
Figure 2. Pipeline™ Flex embolization device
(Resheathing schematic as seen under uoroscopy, image not to scale).
1. Proximal End of device 5. Proximal Bumper
2. Micro Catheter 6. Delivery Wire
3. Micro Catheter Distal Marker 7. Resheathing Limit
5
Table 2. Serious adverse events in PUFS-PAS by MedDRA®* category and term – cumulative
incidence at 180 days, one year, three years and ve years (N= 134 subjects).
MedDRA®*
Category
Nervous system
disorders
MedDRA®* Term 180 days 1 year 3 year 5 year
Total 18
(13.4%)
18
(13.4%)
24
(17.9%)
27
(20.1%)
Cerebral haemorrhage 6 (4.5%) 6 (4.5%) 6 (4.5%) 6 (4.5%)
Headache 5 (3.7%) 6 (4.5%) 6 (4.5%) 6 (4.5%)
Cerebral ischaemia 3 (2.2%) 3 (2.2%) 3 (2.2%) 3 (2.2%)
Convulsion 0 (0.0%) 0 (0.0%) 0 (0.0%) 2 (1.5%)
Iiird nerve disorder 2 (1.5%) 2 (1.5%) 2 (1.5%) 2 (1.5%)
Ischaemic stroke 2 (1.5%) 2 (1.5%) 2 (1.5%) 2 (1.5%)
Syncope 0 (0.0%) 1 (0.7%) 2 (1.5%) 2 (1.5%)
Carotid artery aneurysm 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Carotid artery occlusion 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Carpal tunnel syndrome 0 (0.0%) 0 (0.0%) 1 (0.7%) 1 (0.7%)
Cerebral artery embolism 0 (0.0%) 0 (0.0%) 1 (0.7%) 1 (0.7%)
Cerebral artery stenosis 0 (0.0%) 0 (0.0%) 1 (0.7%) 1 (0.7%)
Cerebrovascular accident 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Dementia alzheimer's type 0 (0.0%) 0 (0.0%) 1 (0.7%) 1 (0.7%)
Dizziness 0 (0.0%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Hemiparesis 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Nervous system disorder 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (0.7%)
Transient ischaemic attack 0 (0.0%) 0 (0.0%) 1 (0.7%) 1 (0.7%)
Vith nerve disorder 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Gastrointestinal
disorders
Total 7 (5.2%) 8 (6.0%) 9 (6.7%) 10 (7.5%)
Gastrointestinal
0 (0.0%) 1 (0.7%) 3 (2.2%) 3 (2.2%)
haemorrhage
Colitis 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Diverticulitis intestinal
0 (0.0%) 0 (0.0%) 1 (0.7%) 1 (0.7%)
haemorrhagic
Intra-abdominal
1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
haemorrhage
Nausea 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Oesophageal spasm 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (0.7%)
Peptic ulcer 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Rectal haemorrhage 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Retroperitoneal haematoma 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Vomiting 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
MedDRA®*
Category
Injury,
poisoning and
procedural
complications
MedDRA®* Term 180 days 1 year 3 year 5 year
Total 5 (3.7%) 5 (3.7%) 7 (5.2%) 10 (7.5%)
Hip fracture 0 (0.0%) 0 (0.0%) 1 (0.7%) 2 (1.5%)
Joint injury 1 (0.7%) 1 (0.7%) 2 (1.5%) 2 (1.5%)
Ankle fracture 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (0.7%)
Arterial injury 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Corneal abrasion 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Procedural haemorrhage 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Road trac accident 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (0.7%)
Vascular pseudoaneurysm 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Surgical
and medical
procedures
Total 0 (0.0%) 2 (1.5%) 9 (6.7%) 10 (7.5%)
Aneurysm repair 0 (0.0%) 2 (1.5%) 6 (4.5%) 6 (4.5%)
Arterial aneurysm repair 0 (0.0%) 0 (0.0%) 1 (0.7%) 1 (0.7%)
Atrial septal defect repair 0 (0.0%) 0 (0.0%) 1 (0.7%) 1 (0.7%)
Intra-cerebral aneurysm
0 (0.0%) 0 (0.0%) 1 (0.7%) 1 (0.7%)
operation
Knee arthroplasty 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (0.7%)
Eye disorders Total 5 (3.7%) 6 (4.5%) 9 (6.7%) 9 (6.7%)
Amaurosis fugax 1 (0.7%) 2 (1.5%) 3 (2.2%) 3 (2.2%)
Ophthalmoplegia 1 (0.7%) 1 (0.7%) 2 (1.5%) 2 (1.5%)
Eye pain 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Retinal artery embolism 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Vision blurred 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Visual impairment 0 (0.0%) 0 (0.0%) 1 (0.7%) 1 (0.7%)
Cardiac
disorders
Total 4 (3.0%) 4 (3.0%) 5 (3.7%) 8 (6.0%)
Atrial brillation 1 (0.7%) 1 (0.7%) 1 (0.7%) 2 (1.5%)
Bradycardia 1 (0.7%) 1 (0.7%) 1 (0.7%) 2 (1.5%)
Arrhythmia 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Myocardial infarction 0 (0.0%) 0 (0.0%) 1 (0.7%) 1 (0.7%)
Ventricular brillation 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Wol-parkinson-white
0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (0.7%)
syndrome
Vascular
disorders
Total 5 (3.7%) 5 (3.7%) 6 (4.5%) 8 (6.0%)
Haematoma 2 (1.5%) 2 (1.5%) 2 (1.5%) 2 (1.5%)
Aneurysm 0 (0.0%) 0 (0.0%) 1 (0.7%) 1 (0.7%)
Deep vein thrombosis 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Embolism 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Hypotension 1 (0.7%) 1 (0.7%) 1 (0.7%) 1 (0.7%)
Intermittent claudication 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (0.7%)
Peripheral vascular disorder 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (0.7%)
*MedDRA® Medical Dictionary for Regulatory Activities
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