Clinical Studies - Stryker Neuroform EZ Mode D'emploi

• Embolus
• Hemorrhage
• In-stent stenosis
• Infection
• Ischemia
• Neurological/intracranial sequelae
• Pseudoaneurysm
• Stent fracture
• Stent migration/embolization
• Stent misplacement
• Stent thrombosis
• Stroke
• Transient ischemic attack
• Vasospasm
• Vessel occlusion or closure
• Vessel thrombosis
• Vessel perforation/rupture, dissection, trauma or damage
• Other procedural complications including but not limited
to anesthetic and contrast media risks, hypotension,
hypertension, access site complications
Refer to the appropriate embolic coil DFU for other complications
that may occur due to coil embolization.
Observed adverse Events from Clinical Studies
Tables 2 and 3 identify the adverse events observed in the
clinical study conducted with the Neuroform
Stent System.
Twenty-nine patients were implanted with the stent. The tables
include all adverse events through 6 months. Of the 29 patients
implanted with the stent, 17 patients had 1 or more adverse
events and 5 had 1 or more serious adverse events. There
were 12 serious adverse events and 21 other adverse events,
all of which occurred prior to or by the time of discharge. None
occurred between discharge and the 6-month timepoint. Nine
patients had 1 adverse event, 4 patients had 2 adverse events,
1 patient had 3 adverse events, 2 patients had 4 adverse events,
and 1 patient had 5 adverse events.
Table 2 summarizes the patient rates for observed serious
adverse events. Table 3 summarizes the patient rates for all
other observed adverse events.
Table 2. Serious Device or Procedure-related adverse Events
Serious adverse Event 1
Death
2
Aneurysm Perforation
2,3
Arterial Perforation
4
Subarachnoid/Interventricular Hemorrhage
Thromboembolic Stroke
4
Intracerebral Hematoma
4
Left Hemiparesis
4
Intraparenchymal Bleeding
3
Retroperitoneal Hematoma
5
Confusion
6
1 Five patients had these 12 serious adverse events. The "n" reflects the number of
occurrences of that adverse event. The % is based on 29 patients who were assessed
before or at discharge when all adverse events occurred.
2 One patient had 3 serious adverse events. There was perforation of the aneurysm
dome with the micro guidewire during the initial catheterization of the aneurysm
resulting in subarachnoid/interventricular hemorrhage and death. Death was due
to complications from aneurysm perforation leading to bleeding and pre-existing
hepatitis and management of anticoagulation therapy.
3 One patient had 3 serious adverse events. There was perforation of the aneurysm with
the microcatheter during coil placement resulting in subarachnoid hemorrhage and
subsequent intraparenchymal bleeding (from the ventricular drainage line).
One patient had 4 serious adverse events. Arterial perforation occurred with the tip
4
of the exchange length guidewire prior to stent insertion, resulting in an intracerebral
hematoma. This patient also had a thromboembolic stroke that led to left hemiparesis.
One patient had a retroperitoneal hematoma.
5
One patient had confusion. Confusion was categorized by the protocol as a non-
6
serious adverse event; however, it was determined by the clinical study investigator to
be a serious adverse event because the patient required a prolonged hospital stay.
Table 3. Other Device or Procedure-related adverse Events
Other adverse Event
Right Hemiparesis
Embolic Event
2
Vasospasm
3
Intimal Dissection
4
Seizure
5
Access Site Hematoma
Liver Failure
Vomiting
Headache
Fever of Unknown Origin
Urinary Tract Infection
Fifteen patients had these 21 adverse events. The "n" reflects the number of occurrences of
1
that adverse event. The % is based on 29 patients who are accounted for and were assessed
before or at discharge when all adverse events occurred.
Includes embolic ischemic lesion, small embolic lesion, asymptomatic microemboli to brain
2
detected by MRI, and left prolonged reversible ischemic neurological deficit (PRIND). All
embolic events resulted in mild neurological deficits. Three completely resolved, and 1 patient
was discharged to a rehabilitation facility.
Includes 4 mild and 1 moderate case. All completely resolved.
3
Occurred during placement of the guide catheter in the cervical internal carotid prior to
4
stent placement, not in the portion of the vessel treated with the device.
One patient with a history of epilepsy experienced a seizure with no permanent sequelae while
5
in the hospital.
Includes 1 mild and 1 moderate case. Both resolved.
6
® Microdelivery
Tables 4 and 5 summarize the adverse events observed in the
clinical study conducted with the Neuroform EZ™ Stent System.
Twenty patients were implanted with 23 stents. The tables include
adverse events through 6 months. In total 71 adverse events occurred
in 19 patients. Of these, 3 patients experienced a total of 3 serious
adverse events (SAEs). Two SAEs were unrelated to the device or
procedure including one case of drug hypersensitivity and one case
of urinary tract infection. One SAE of retroperitoneal hematoma was
related to the procedure. Two non-serious events were classified
as having a relationship to the device including one case of retinal
artery occlusion reported the day of the procedure and one case of
in-stent stenosis reported at 6 month follow-up. Table 4 summarizes
all observed adverse events. Table 4 summarizes adverse events
classified as having a relationship to the device or procedure. Table 5
summarizes all observed adverse events.
Table 4. adverse Events related to Device or Procedure
n (%)
related adverse Events
1 (3.4%)
Total
2 (6.9%)
Headache
1 (3.4%)
Nausea
2 (6.9%)
2,3
Asymptomatic cerebral infarction
1 (3.4%)
Alopecia
1 (3.4%)
Bleeding from puncture site
1 (3.4%)
Subcutaneous hematoma
1 (3.4%)
3rd cranial nerve palsy
1 (3.4%)
Cerebral artery in-stent stenosis
1 (3.4%)
Diplopia
Hemianopsia
Hypesthesia
Memory impairment
Retinal artery occlusion
Retro-peritoneal hematoma
n (%)
1
1 (3.4%)
4 (13.8%)
5 (17.2%)
1 (3.4%)
1 (3.4%)
2 (6.9%)
6
1 (3.4%)
1 (3.4%)
3 (10.3%)
1 (3.4%)
1 (3.4%)
n (%)
17 (85.0%)
11 (55.0%)
4 (20.0%)
7 (35.0%)
3 (15.0%)
2 (10.0%)
2 (10.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
2
Table 5. adverse Events
adverse Events
Total
Headache
Nausea
Asymptomatic cerebral infarction
Alopecia
Hepatic function abnormalities
Bleeding from puncture site
Gastrointestinal hemorrhage
Subcutaneous hematoma
Subcutaneous hemorrhage
3rd cranial nerve palsy
Back pain
Blood glucose increased
Blood pressure decreased
Blurred vision
Cerebral artery in-stent stenosis
Chorioretinal atrophy
Cystitis
Decreased urinary volume
Diplopia
Dizziness
Drug hypersensitivity
Eye pain
Gastrointestinal problems
Hemianopsia
Hypesthesia
Hyponatremia
Memory impairment
Optic nerve disorders
Retinal artery occlusion
Retinal hemorrhage
Retro-peritoneal hematoma
Upper abdominal pain
Urinary tract infection
*Classified as serious adverse events

CLiniCaL STUDiES

A Clinical study was conducted in Europe to evaluate the
Neuroform Microdelivery Stent System. The patient inclusion
criteria were: (1) wide neck, ruptured or unruptured, saccular,
intracranial aneurysm or aneurysm on the level of the skull
base, where a wide neck is defined as a dome-to-neck ratio
< 2 and/or neck length of ≥ 4 mm; (2) aneurysm is in artery with
diameter ≥ 1.5 mm and ≤ 5.5 mm; (3) patient is ≥ 18 years old;
and (4) patient provided written informed consent.
There were 31 patients entered into the study. Five (16%) were
male and 26 (84%) were female. Fifty-two percent of the patients
were asymptomatic prior to treatment. Two of the 31 patients
did not receive the stent because of failure to access based on
anatomy. The remaining 29 patients enrolled in the study had 30
aneurysms (1 patient had 2 aneurysms that were treated with
one stent). Previous attempts had been made to treat 17 of the
30 aneurysms (57%) using other devices.
Table 6 summarizes the locations of the 30 aneurysms. Table 7
summarizes the sizes of the 30 aneurysms.
n (%)
19 (95.0%)
16 (80.0%)
9 (45.0%)
7 (35.0%)
3 (15.0%)
3 (15.0%)
2 (10.0%)
2 (10.0%)
2 (10.0%)
2 (10.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
1* (5.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
1 (5.0%)
1* (5.0%)
1 (5.0%)
1* (5.0%)
Black (K) ∆E ≤5.0