Stryker Neuroform EZ Instrucciones De Uso página 3

• 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 Study
Tables 2 and 3 identify the adverse events observed in the clinical study conducted with the Neuroform™
Microdelivery 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
2,3
Thromboembolic Stroke
4
Intracerebral Hematoma 4
Left Hemiparesis
4
Intraparenchymal Bleeding
3
Retroperitoneal Hematoma
5
Confusion
6
Five patients had these 12 serious adverse events. The "n" reflects the number of occurrences of that adverse event. The % is
1
based on 29 patients who were assessed before or at discharge when all adverse events occurred.
One patient had 3 serious adverse events. There was perforation of the aneurysm dome with the micro guidewire during the
2
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.
One patient had 3 serious adverse events. There was perforation of the aneurysm with the microcatheter during coil placement
3
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 of the exchange length guidewire prior to
4
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-serious adverse event; however, it was
6
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 that adverse event. The % is based
1
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 detected by MRI, and left prolonged
2
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 stent placement, not in the portion of the
4
vessel treated with the device.
One patient with a history of epilepsy experienced a seizure with no permanent sequelae while in the hospital.
5
Includes 1 mild and 1 moderate case. Both resolved.
6
n (%)
1 (3.4%) CLInICaL STUDY
This was a European clinical study. The patient inclusion criteria were: (1) wide neck, ruptured or unruptured,
2 (6.9%)
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;
1 (3.4%)
(3) patient is ≥ 18 years old; and (4) patient provided written informed consent.
2 (6.9%)
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
1 (3.4%)
stent because of failure to access based on anatomy. The remaining 29 patients enrolled in the study had
1 (3.4%) 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.
1 (3.4%)
Table 4 summarizes the locations of the 30 aneurysms. Table 5 summarizes the sizes of the 30 aneurysms.
1 (3.4%)
Table 4. aneurysm Location
1 (3.4%)
Location
1 (3.4%)
Carotid ophthalmic
Posterior communicating artery
Carotid cavernous
Anterior choroidal
Basilar tip
Carotid bifurcation
Middle cerebral artery
Anterior cerebral artery
Vertebral artery
Posterior inferior cerebellar artery
Basilar trunk
Other
3
1
6
n
7
7
5
2
2
1
1
1
1
1
1
1
n (%)
1 (3.4%)
4 (13.8%)
5 (17.2%)
1 (3.4%)
1 (3.4%)
2 (6.9%)
1 (3.4%)
1 (3.4%)
3 (10.3%)
1 (3.4%)
1 (3.4%)
%
24%
24%
17%
7%
7%
3%
3%
3%
3%
3%
3%
3%
Black (K) ∆E ≤5.0