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General| Brand | Medtronic |
|---|---|
| Model | Endurant II |
| Category | Medical Equipment |
| Language | English |
Describes the Endurant II/IIs stent graft, its configurations, and materials.
Covers general usage information, physician training, and handling precautions.
Details criteria for selecting appropriate patients for the Endurant II/IIs stent graft system.
Outlines necessary preoperative planning and device inspection before implantation.
Details precautions and steps to follow during the stent graft implantation procedure.
Covers management of endoleaks and follow-up imaging recommendations.
Lists potential adverse events associated with the device, including amputation, bleeding, and infection.
Emphasizes the physician's responsibility for correct device sizing based on patient anatomy.
States that each configuration is sterilized by electron beam and supplied sterile for single use.
Lists the components included in the package: stent graft system and web reference leaflet.
Provides storage instructions for the system at room temperature in a dark, dry place.
Outlines the knowledge and skill requirements for physicians using the Endurant II/IIs stent graft system.
Lists the available sizes for the Endurant II/IIs stent graft systems and provides contact information for sizing questions.
Instructs users to inspect the device and packaging for damage or defects before use.
Lists essential additional equipment needed for infrarenal EVAR procedures.
Lists recommended supplementary equipment for the procedure.
Provides safety information for scanning patients with the Endurant II/IIs stent graft in an MR system.
Covers determining correct sizing of aorta and iliac vessels and preparing the device.
Explains the procedure for renal cannulation using axillary or brachial access.
Instructions for introducing the bifurcated configuration into the patient's vasculature.
Guides on confirming the correct position of the contralateral stub leg.
Step-by-step instructions for deploying the proximal end of the bifurcated configuration.
Instructions for deploying the contralateral leg of the bifurcated configuration.
Details the steps for releasing the suprarenal stent's proximal end.
Instructions for deploying the distal end of the bifurcated configuration.
Steps for recapturing the spindle in the tapered tip.
Instructions for removing the delivery system for the Endurant II bifurcated configuration.
Details the procedure for disassembling the screw gear handle.
Describes the ballooning technique to deploy the suprarenal stent if the back-end wheel section is still functional.
Describes the procedure for disassembling the back-end handle if it fails.
Explains how to snare the tapered tip technique if the back-end handle disassembly technique is unsuccessful.
Discusses general imaging practices for stent graft patients, including modalities and frequency.
Specifies the use of abdominal X-rays for assessing stent graft fracture.
Details the use of contrast-enhanced CT for assessing stent graft fixation, migration, and endoleaks.
Describes the use of noncontrast CT for patients with impaired renal function or contrast allergies.
Explains the use of color duplex ultrasound for assessing AAA diameter, endoleaks, and stent graft occlusion/stenosis.
Discusses the use of MRI or MRA for patients with impaired renal function.
Refers to Table 9 for the recommended follow-up imaging schedule.
