Adverse Events - Stryker Surpass Streamline Gebrauchsanweisung

PRECAUTIONS
• Experience with device implants indicates that there is a risk of stenosis. Subsequent
stenosis may require dilatation of the vessel segment containing the device. The risks
and long-term outcome following dilatation of endothelialized devices is unknown at
present.
• Confirm the device labeling reflects the desired size of the target vessel where the device
is to be used.
• Do not expose the system to organic solvents (e.g., alcohol).
• Appropriate anti-platelet and anti-coagulation therapy should be employed in
accordance with standard medical practice.
• A thrombosing aneurysm may aggravate pre-existing or cause new symptoms of mass
effect and may require medical therapy.
• Use product prior to the "Use By" date.
• The ability of the device to withstand balloon post-dilatation has not been established.
• Do not remove the Surpass™ Flow Diverter from its Delivery System. The device and
Delivery System are intended to perform as a single system and must not be altered.
• Carefully inspect the device packaging and system prior to use. Do not use the Surpass
Flow Diverter if any component appears damaged or missing.
• Carefully remove the tray lid and grasp the Delivery System by its RHV and hoop to
facilitate removal from the tray.
• Select a device length that is at least 10 mm longer than the aneurysm neck to maintain a
minimum of 5 mm on either side of aneurysm neck.
• Do not attempt to partially deploy and recapture the Surpass Flow Diverter more than
three times.
• Use caution when crossing the deployed device with guidewires or other accessory
devices.
• Dispose of all used devices in accordance with hospital policy for biohazardous
materials.
• Do not attempt to move the Surpass Flow Diverter more distally once it has begun to
appose the vessel walls.
• Do not apply additional force if significant resistance is experienced while attempting to
recapture the flow diverter.

ADVERSE EVENTS

Risks that may be associated with the use of the Surpass Flow Diverter in the intracranial
arteries include:
• Aneurysm recanalization
• Aneurysm enlargement
• Allergic reaction, including, but not limited to,
an allergic reaction to contrast, nickel, cobalt
chromium or platinum tungsten metal, and
medications
• Arrhythmia
• Arteriovenous fistula
• Confusion, coma, loss of consciousness or
other change in mental status
• Death
• Detachment of a component of the system
• Emboli (air, tissue or thrombotic emboli)
• Emergent neurosurgery
• Failure to deliver the device to the intended site
• Headache
• Hemorrhage (including intracranial, vascular,
peritoneal, and groin)
• Hematoma
• Hypotension / Hypertension
• Hydrocephalous
• Incomplete Aneurysm Occlusion
• Infection
• Injury to normal vessels or tissue
please notify your Stryker Neurovascular representative immediately if a device malfunctions
or patient complication or injury is experienced or suspected. please make every attempt
to retain any suspect device, its associated components and their packaging for return to
Stryker Neurovascular.
MAGNETIC RESONANCE IMAGING (MRI) INFORMATION
The Surpass Flow Diverter was determined to be mR Conditional.
Non-clinical testing demonstrated that the Surpass Flow Diverter is mR Conditional. A patient
with this device can be scanned safely immediately after placement under the following
conditions:
Static Magnetic Field
• Static magnetic field of 3-Tesla or less
• Maximum spatial gradient magnetic field of 2,000-Gauss/cm or less*
• MR system operating in the First Level Controlled Mode (i.e., the mode of operation of the
mR system in which one or more outputs reach a value that may cause physiological
stress to patients which needs to be controlled by medical supervision) at a whole body
averaged SAR of 4.0-W/kg for 15 min. of scanning (i.e., per pulse sequence)
*Translational Attraction
The measured value of the highest spatial gradient used for the assessment of
translational attraction for the Surpass Flow Diverter implant was 720-Gauss/cm.
The calculated acceptable level for the spatial gradient magnetic field was based on
consideration of this value along with the magnetic field strength at this position, the
measured deflection angle for this implant, and includes a margin of safety.
MRI-Related Heating
In non-clinical testing, the Surpass Flow Diverter produced the following temperature
rise during mRI performed for 15-min of scanning (i.e., per pulse sequence) in the 3-Tesla
(3-Tesla/128-MHz, Excite, HDx, Software 14X.M5, General Electric Healthcare, Milwaukee,
WI) mR system:
Highest temperature Change + 2.3°C
3
• Ischemia
• Occlusion of side branch
• Mass effect
• Myocardial infarction
• Nausea
• Neurologic deficit
• Pain at insertion site
• Perforation of aneurysm
• Pseudoaneurysm
• Reactions due to radiation exposure
• Renal failure
• Rupture, vessel or aneurysm
• Seizures
• Stenosis of treated segment
• Device migration / embolization
• Device thrombosis / occlusion
• Stroke /TIA/ cerebrovascular accident –
new or worsening of symptoms
• Total occlusion of treated segment
• Vasospasm
• Vessel dissection or perforation
• Vessel thrombosis/occlusion
• Visual impairment/blindness
• Vomiting
Black (K) ∆E ≤5.0