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Patient Implant Card and Patient Information Brochure
A Patient Implant Card is provided within this IFU. The patient, implant and hospital information should be recorded on the card
as requested. Ensure a peel-away sticker from the product label is placed on the card before it is given to the patient. The sticker
contains important information about the implant. The patient should carry the implant card with them and present it to any
medical personnel involved in their care.
Please visit eIFU.bd.com for the Patient Information Brochure. The brochure should be made available to the patient. It contains
additional important information about this product.
Directions for Use
Pre-Deployment Procedure
1. Inject Contrast Media
Perform an angiogram using standard technique.
2. Evaluate and Mark Target Site
Fluoroscopically evaluate and mark the target site, observing the most distal diseased or obstructed segment.
3. Select Stent Size
Measure the length of the target lesion to identify the appropriate length of stent(s) required. Ensure that the stent is long
enough to permit the area proximal and distal to the lesion or stricture to be covered by the stent.
Note:
The LifeStent™ XL Vascular Stent foreshortening is less than 10 %.
Identify the diameter of the reference vessel (proximal and distal to the lesion). To ensure secure placement, refer to the stent
size selection table for proper sizing scheme (Table 2).
Stent Size Selection Table
Reference Vessel
Diameter
4.0 – 4.5 mm
4.5 – 5.5 mm
5.5 – 6.5 mm
Table 2: Stent Size Selection Table
Refer to product labeling for stent length.
4. Materials Required
In addition to the LifeStent™ XL Vascular Stent, the following standard materials may also be required to facilitate delivery
and deployment of the LifeStent™ XL Vascular Stent:
• normal, sterile saline
• 6F (2.0 mm) or larger introducer sheath
• 0.035 inch (0.89 mm) diameter guidewire
• standard balloon angioplasty (PTA) catheter
• contrast medium
• inflation device
• appropriate anticoagulation and antiplatelet drugs
5. Prepare Stent Delivery System
a) Open the box and remove the pouch containing the stent system.
b) Check the temperature exposure indicator label on the pouch to confirm that the grey background is clearly visible.
See "Warnings" section.
c) Carefully inspect the pouch to ensure that the sterile barrier has not been compromised. Then, peel open the pouch and remove
the tray containing the stent system. Extract the stent system from the tray and check the following:
i) Examine the stent system to ensure it has not been damaged during shipment and that its size, shape and condition
are suitable for the procedure for which it is to be used.
If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.
ii) Verify that the shipping lock is still secure in the delivery system handle.
d) Visually inspect the distal end of the delivery system catheter to ensure that the stent is contained within the sheath.
DO NOT use if the stent is partially deployed.
e) Flush the inner lumen of the device with normal, sterile saline prior to use.
f) Wipe the usable length portion of the delivery system catheter with a gauze soaked with normal, sterile saline.
Stent Deployment Procedure
1. Insert Introducer Sheath and Guidewire
a) Gain femoral access utilizing a 6F (2.0 mm) or larger introducer sheath.
b) Insert a 0.035 inch (0.89 mm) diameter guidewire of appropriate length (Table 3) across the lesion to be stented via the
introducer sheath.
Recommended Guidewire Length Table
Catheter Working Length
130 cm
80 cm
Table 3: Recommended Guidewire Length Table
2. Dilate Lesion
Predilation of the lesion should be performed using standard techniques. While maintaining site access with a guidewire,
remove the balloon catheter from the patient.
Caution:
During dilation, DO NOT expand the balloon such that dissection complication or perforation could occur.
3. Introduce Stent Delivery System
a) Advance the device over the 0.035 inch (0.89 mm) diameter guidewire through the sheath introducer. Always use for
contralateral access the stent system in conjunction with a long introducer sheath which covers the aortic bifurcation.
Note:
If resistance is met during delivery system introduction, the system should be removed and another system
should be used.
Caution:
Always use an introducer sheath for the implant procedure to protect the vasculature and the puncture site.
A 6F (2.0 mm) or larger introducer sheath is recommended.
b) Position the tip of the delivery system past the target site.
c) Pull back the delivery system until the distal and proximal ends of the stent are in position so that they are distal and proximal
to the target site.
d) Remove slack from the delivery system catheter held outside the patient.
Caution:
Any slack in the delivery system catheter (outside the patient) could result in deploying the stent beyond the target site.
Unconstrained Stent
Inner Diameter
5.0 mm
6.0 mm
7.0 mm
Recommended Guidewire Length
300 cm
260 cm
4. Deploy Stent
a) Verify that the distal and proximal stent ends are distal and proximal to the target lesion.
b) Confirm that the introducer sheath is secure and will not move during deployment.
c) Remove the shipping lock.
d) To ensure the most accurate placement, firmly hold the black system stability sheath throughout deployment.
Note:
DO NOT hold the silver stent delivery sheath at any time during deployment. DO NOT constrict the stent
delivery sheath during stent deployment.
e) Initiate stent deployment by rotating the thumbwheel in the direction of the arrows, while holding the handle in a fixed position.
Note:
If excessive force is felt during stent deployment, do not force the stent system. Remove the stent system
as possible and replace with a new unit.
f) While using fluoroscopy, maintain position of the distal and proximal stent ends relative to the target site. Rotate
thumbwheel (Fig. 3), watch for the distal stent end to begin expanding; separation of the distal stent end signals that the
stent is deploying. Continue turning the thumbwheel until the distal end of the stent obtains a minimum of 1 cm of wall apposition.
While maintaining a fixed handle
position, rotate thumbwheel
to obtain initial stent wall
apposition of 1 cm minimum.
Figure 3. Initial Thumbwheel Deployment
Note:
The thumbwheel is designed to initially deploy the stent distal end a minimum of 1 cm. Final stent
deployment is achieved by using the deployment lever.
g) With distal end of the stent apposing vessel wall, deployment continues with the following method (Fig. 4).
While maintaining a fixed handle position, place
your finger in front of the deployment
slide and slide it from the distal to
proximal end.
Figure 4. Fast Track Deployment Lever
Note:
To ensure correctly deployed stent length, fluoroscopically monitor the distal stent end initially until wall
apposition then monitor the delivery system proximal radiopaque marker relative to the proximal edge of the
target site.
h) Deployment of the stent is complete when the proximal stent end apposes the vessel wall and the sheath radiopaque zone
is proximal to the proximal end of the stent.
i) DO NOT attempt to recapture the stent.
5. Post Stent Placement
a) Remove the delivery system from the body.
Note:
If resistance is met while retracting the delivery system over a guidewire, remove the delivery system and
guidewire together.
b) Visually confirm the delivery system integrity after removal.
c) Post stent expansion with a PTA catheter is recommended. If performed, select a balloon catheter that matches the size of the
reference vessel, but that is not larger than the stent diameter itself.
d) Using standard procedures, verify location and patency of the stent.
e) Remove the guidewire and introducer sheath from the body.
f) Close entry wound as appropriate.
Note:
Physician experience and discretion will determine the appropriate antithrombotic drug regimen for each
individual patient.
Disposal Instructions
After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and
applicable local, state, and federal laws and regulations.
Warranty
Please refer to the product information at eIFU.bd.com for further details.
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