English - Bard COVERA PLUS Instructions For Use Manual

English

DEVICE DESCRIPTION
IMPLANT
The C ™ P
Vascular Covered Stent is a highly flexible, self-expanding endoprosthesis comprised of expanded
OVERA LUS
polytetrafluoroethylene (ePTFE) encapsulating a nitinol (nickel-titanium) stent framework. The inner lumen of the covered stent
(blood contact surface) is carbon impregnated.
The C ™ P
OVERA LUS Vascular Covered Stent is available in a variety of diameters and lengths.
Figure 1: Covered Stent Implant
XRAY MARKERS
Highly radiopaque ePTFE encapsulated tantalum markers are evenly distributed around the circumference of the proximal and
distal ends of the covered stent.
DELIVERY SYSTEM
The delivery system is illustrated in Figure 2. The inner catheter (not visible to the operator) contains the guidewire lumen.
The inner catheter carries an atraumatic tip (A) at the distal end of the system and enters into a female Luer connection (B) at
the proximal end of the handle. A proximal white stability sheath (C) is connected to the distal end of the handle and remains
stationary throughout the deployment process.
The distal catheter assembly (30 cm in length) consists of two segments: the transparent covered stent delivery sheath (D),
housing the compressed covered stent (implant); and a darker brown, smaller diameter extension catheter (E). During covered
stent deployment, the entire distal catheter assembly retracts towards the handle while the dark catheter segment is drawn
inside the white stability sheath until the covered stent is fully deployed.
Retraction of the distal catheter and deployment of the covered stent is initiated by rotating the large wheel (G) on the handle.
The large deployment wheel is used for the initiation of deployment and a slower deployment rate whereas the small deployment
wheel (H) may be used for faster deployment after initiation.
Figure 2: Itemized Drawing of the C ™ P
OVERA LUS Vascular Covered Stent Delivery System
A red safety lock (F) on the handle prevents premature release of the covered stent. Prior to covered stent deployment, the safety
lock must be retracted from the locked position into the unlocked position (Figure 3).
3
Figure 3: Handle Top View
1 = Red Safety Lock (F)
2 = Large Deployment Wheel for initial and slow deployment (G)
3 = Small Deployment Wheel for faster deployment (H)
Legend for Figures 2 & 3
Reference Corresponding Information
A Delivery System Tip
B Female Luer Port
C Proximal Stability Sheath (white, stationary)
Distal Catheter Sheath Segment (transparent, retracts during deployment) housing the Compressed
D
Covered Stent
E Distal Catheter Sheath Segment (dark brown, retracts during deployment)
F Red Safety Lock
G Large Deployment Wheel (initial and slow deployment)
H Small Deployment Wheel (fast deployment)
The C ™ P
Vascular Covered Stent device is an over-the-wire delivery system. The delivery system is compatible with
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0.035 inch (0.89 mm) guidewires and 8F or 9F introducer sheaths. The delivery system is available in working lengths of 80 cm
and 120 cm.
INDICATION FOR USE
The C ™ P
OVERA LUS Vascular Covered Stent is indicated for the treatment of stenoses in the upper extremity venous outflow of
patients dialyzing with an arterio-venous (AV) access graft or fistula and for the treatment of atherosclerotic lesions in iliac and
femoral arteries with a reference vessel diameter of 4.5 mm to 9 mm.
CONTRAINDICATIONS
There are no known contraindications for the C ™ P
OVERA
WARNINGS
associated with dialysis access shunt revisions and endovascular procedures.
DO NOT expose the covered stent to temperatures higher than 680 °F (360 °C). ePTFE decomposes at elevated temperatures,
producing highly toxic decomposition byproducts.
DO NOT use the device if packaging/pouch is damaged.
DO NOT use the device after the "Use By" date specified on the label.
C ™ P
Vascular Covered Stent device is supplied STERILE and is intended for SINGLE USE ONLY. DO NOT
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RESTERILIZE AND/OR REUSE the device.
Reuse, resterilization, reprocessing and/or repackaging may create a risk to the patient or user, may lead to infection or
compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to
device failure, and/or lead to injury, illness, or death of the patient.
Vascular Covered Stent.
LUS