12
•
Store in a cool, dry place.
•
For single patient use only.
Do not reuse, reprocess or re-sterilize. Reuse,
reprocessing or re-sterilization may compromise the structural integrity of the
device and/or lead to device failure that may result in patient injury, illness or
death. Reuse, reprocessing or re-sterilization may also create a risk of
contamination of the device and/or cause patient infection, including, but not
limited to, the transmission of infectious disease(s) from one patient to
another. Contamination of the device may lead to injury, illness or death of
the patient.
•
After use, dispose of the product and packaging in accordance with hospital,
administrative and/or local government policy.
9.
Clinician Use Information
9.1. Physician Training
CAUTION: Always have a vascular surgery team available during
implantation or re-intervention procedures in the event that conversion to
open surgical repair is necessary.
CAUTION: The Ovation Abdominal Stent Graft System should only be used
by physicians and teams trained in vascular interventional techniques and
in the use of this device.
The recommended skill/ knowledge requirements for physicians using the Ovation
Abdominal Stent Graft System are outlined below.
Patient Selection:
•
Knowledge of the natural history of abdominal aortic aneurysm (AAA) and
co-morbidities associated with AAA repair.
•
Knowledge of radiographic image interpretation, device selection and sizing.
A multi-disciplinary team that has combined procedural experience with:
•
Femoral cutdown, arterial bypass, arteriotomy, and repair
•
Percutaneous access and closure techniques
•
Non-selective and selective guidewire and catheter techniques
•
Fluoroscopic and angiographic image interpretation
•
Embolization
•
Angioplasty
•
Endovascular stent placement
•
Snare techniques
•
Appropriate use of radiographic contrast material
•
Techniques to minimize radiation exposure
•
Expertise in necessary patient follow-up modalities
9.2. Inspection Prior to Use
Inspect the device and packaging to verify that no damage has occurred as a result
of shipping. Do not use this device if damage has occurred or if the sterilization
barrier has been damaged or broken. If damage has occurred, do not use the
product and contact your TriVascular representative for return information.
9.3. Materials Required
