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4.
Warnings and Precautions
4.1. General
•
Accurate fluoroscopic imaging is required during any endovascular
procedure and for proper device deployment. Implantation of this device
should occur in an operating room, endovascular suite, catheterization
laboratory, or similar sterile environment, with appropriately trained
personnel, and suitable equipment and imaging capabilities.
•
Do not use this device if the patient is unable to be evaluated using the
necessary preoperative and postoperative imaging.
•
Read all instructions carefully. Failure to properly follow the instructions,
warnings, and precautions may lead to serious consequences or injury to
the patient.
•
Always have a qualified surgery team available during implantation or re-
intervention procedures in the event that conversion to open surgical repair
is necessary.
•
The TriVascular Ovation Abdominal Stent Graft System should only be used
by physicians and teams experienced in endovascular techniques, and who
have been trained in its use. This experience should include:
-
Vascular access techniques
-
Guidewire and catheter techniques
-
Fluoroscopic and angiographic image interpretation
-
Embolization
-
Angioplasty
-
Endovascular stent placement
-
Appropriate use of contrast agents
-
Techniques to minimize radiation exposure
-
Expertise in patient follow-up modalities
•
The long-term performance of this implant has not been established. All
patients treated with this device must undergo periodic imaging to evaluate
the stent graft, aneurysm size, aneurysm pulsatility, device migration, leaks,
device integrity and occlusion of vessels in the treatment area. Significant
aneurysm enlargement, evidence of perigraft flow, the appearance of a new
endoleak, change in aneurysm pulsatility, device migration and/or reduced
blood flow through the graft should prompt further investigation into the need
for further patient treatment.
•
All patients should be carefully counseled on the need for long-term follow
up. The device is not recommended in patients unable or unwilling to comply
with the information in Follow-up Imaging Recommendations.
4.2. Patient and Device Selection
•
Access vessel diameter, vessel morphology and delivery system diameter
should be compatible with vascular access techniques. Vessels that are
significantly calcified, occlusive, tortuous or thrombus-lined may preclude
placement of the device.
•
Irregular calcification and/or plaque may compromise the fixation and
sealing of the implantation sites.
•
This device is not recommended in patients who: have or are suspected of
having an active systemic infection; cannot tolerate contrast agents
necessary for intra-operative and post-operative follow up imaging; and/or
have sensitivities or allergies to the stent graft system materials.
4.3. Implant procedure
•
Carefully inspect the device packaging and device for damage or defects
prior to use. If signs of damage or defects exist or if premature breach of the
sterile barrier is observed, do not use the device.
