Bard COVERA PLUS Instructions For Use Manual page 4

Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long
and small lumina, joints, and/or crevices between components – are difficult or impossible to clean once body fluids or tissues
with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period
of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms
which may lead to infectious complications or death.
DO NOT use in patients with uncorrectable coagulation disorders.
DO NOT use in patients that cannot be adequately pre-medicated.
DO NOT use in patients who have a known allergy or sensitivity to contrast media.
DO NOT use in patients with known hypersensitivity to nickel-titanium or tantalum.
DO NOT use the device in patients where full expansion of an appropriately sized PTA balloon catheter could not be achieved
during pre-dilation with an angioplasty balloon.
DO NOT use in patients who cannot receive recommended antiplatelet and/or anticoagulation therapy.
DO NOT use in patients with functionally relevant arterial obstruction of the inflow path, poor outflow or no distal runoff.
DO NOT place in patients with a target lesion with a large amount of adjacent acute or subacute thrombus.
DO NOT use for the treatment of lesions that would prevent a surgical salvage bypass procedure.
DO NOT track and deploy the 9F endovascular system across the aorto-iliac bifurcation in crossover fashion since this may
result in failure to deploy the covered stent.
SPECIFIC AV ACCESS RELATED WARNINGS
DO NOT use in patients whose AV access grafts have been implanted for less than 30 days or in an immature fistula.
access.
DO NOT use in patients with bacteremia or septicaemia and/or evidence of fistula or graft infection.
PRECAUTIONS
deployment.
stent system should be used.
DO NOT introduce or manipulate the delivery system without an appropriately sized guidewire and without fluoroscopic
guidance.
DO NOT use a kinked delivery system.
bifurcation. Make sure that the proximal covered stent end is positioned in a straight section of the vessel during deployment.
DO NOT hold the 30 cm long distal catheter assembly segment as it must be free to move and
slide into the white stability sheath.
deployment.
manufacturers.
SPECIFIC AV ACCESS RELATED PRECAUTIONS
not be directly cannulated for hemodialysis and that applying pressure to the implant area should be avoided.
POTENTIAL COMPLICATIONS AND ADVERSE EVENTS
Complications and Adverse Events associated with the use of the C
complications associated with endovascular stent and covered stent placement and dialysis shunt revisions.
Potential complications may include, but are not limited to:
Abscess; access site infection; allergic/anaphylactoid reaction; amputation; aneurysm; angina/coronary ischemia; arteriovenous
fistula; arrhythmia; bleeding at access site; bypass surgery; cerebrovascular accident; congestive heart failure; embolization;
extravasation; fever; hematoma; hemorrhage; hemoptysis; hypotension/hypertension; intimal injury/dissection; ischemia/
infarction of tissue/organ; infection; myocardial infarction; occlusion; pain; pulmonary embolism; perforation; prolonged
bleeding; pseudoaneurysm; rash; reaction to contrast; renal failure; renal toxicity; radiation injury; restenosis; septicemia/
bacteremia; sepsis; stroke; thrombus; vasospasm; ventricular fibrillation; vessel rupture and death.
AV Access specific adverse events may include, but are not limited to:
Arm or hand edema; steal syndrome; and face or neck edema.
Covered stent specific events that could be associated with clinical complications include, but are not limited to:
Embolism; fracture; insufficient covered stent expansion; kinking; malapposition; migration and misplacement; and side branch
occlusion.
Delivery System specific events that could be associated with clinical complications include, but are not limited to:
Blood leakage from delivery system; bond joint failures; delivery system kinking; detachment of parts; failure to deploy; high
deployment forces; inability to track to target location; inaccurate deployment; incompatibility with accessory devices; no
visibility under fluoroscopy; and premature deployment.
COVERED STENT SIZE SELECTION
Special care must be taken to ensure that an appropriately sized device is selected. In the case of a diameter difference between
the inflow and the outflow end, always use the inflow vessel or AV graft diameter as the reference vessel diameter.
Table 1: Covered Stent Diameter Selection
Covered Stent Diameter
6 mm
7 mm
8 mm
9 mm
10 mm
Covered Stent Length
Ensure the selected covered stent length covers the entire lesion and both ends of the implant extend at least 5 mm into the non-
diseased segment of the vessel. In the case of overlapping devices, at least 10 mm of overlap between devices is recommended.
For covered stent placements in the proximal cephalic arch, select the length so that the ostial lesion is fully covered and so that
the proximal covered stent end does not compromise the flow in the axillary/subclavian vein. Ensure that the covered stent end
extends at least 10 mm beyond the arch curvature into the straight distal cephalic vein segment.
NOTE: The C ™ P
Vascular Covered Stent foreshortening is ≤ 13%.
OVERA LUS
4
™ P
OVERA LUS Vascular Covered Stent may include the usual
Recommended Oversizing Reference Vessel Diameter
0.5 mm – 1.5 mm 4.5 mm – 5.5 mm
0.5 mm – 1.5 mm 5.5 mm – 6.5 mm
1 mm – 2 mm 6 mm – 7 mm
1 mm – 2 mm 7 mm – 8 mm
1 mm – 2 mm 8 mm – 9 mm