Recommended Drug Treatment; Warnings; Precautions; Resistant Stent System Handling - Precautions - Eucatech Resistant Gebrauchsanweisung

Incomplete or hindered delivery or expansion or false positioning of the stent
•
Thrombosis / occlusion in the stent
•
Restenosis
•
The treatment is performed in combination with X-radiation and contrast agents. A precise indication for stent place-
ment is advised upon screening of patients who should follow treatment with RESISTANT stent system.
This product can cause an intolerance reaction in people with an allergy to nickel and / or titanium.
Persons allergic to the recommended materials or medications, e.g. radiographic contrast agents or anti-coagulants may
experience an allergic reaction.
Furthermore, complications unknown to date may occur.
Other possible complications include pulmonary infection, urinary tract infection, renal failure, nausea or vomiting,
dizziness / drowsiness.
Complications may require surgery, re-dilatation, drug treatment or another intervention.
6 Recommended drug treatment
Implantation of a RESISTANT stent should be performed in connection with a treatment with platelet aggregation inhi-
bitors as required by the physician, and which has already taken effect at the time of stent implantation.
A follow-up drug regimen in accordance with the current guidelines of the radiological organisations (ACR:
www.acr.org or DRG: www.drg.de) is recommended.

7 Warnings

Should unusual resistance be felt at any time during lesion access or removal of the RESISTANT stent system,
•
the guide catheter or the insert equipment and the RESISTANT stent system should be removed as a single unit.
Applying excessive force to the RESISTANT stent system can result in the loss of or damage to the balloon and/
or the components of the RESISTANT stent system.
Because the use of this RESISTANT stent system is associated with the risk of a subacute thrombosis, vascular
•
complications and / or haemorrhages, meticulous screening of patients and post-interventional monitoring are
indispensable.
Do not use a guide wire with a diameter greater than 0.035" (0.89 mm).
•
Inject the contrast agent for detecting obstacles while passing the RESISTANT stent system through the guide
•
catheter or the insert equipment.
The proximal part of the stent system handle is to be held in a spatially stable position during delivery; otherwise,
•
the stent length can shorten or extend itself during delivery or there can be an increase in the acting delivery
forces. The stent may not be stretched beyond the nominal length.
The RESISTANT stent is not suited for repositioning after delivery. It cannot be returned to the delivery system.
•
The effects of overlapping stents are not known to date.
•
An allergic reaction can occur in people with nickel and / or titanium intolerance.
•
Persons allergic to the recommended materials or medications, e.g. radiographic contrast agents or anti-coagu-
•
lants may experience an allergic reaction.

8 Precautions

(Please also refer to section "Individualisation of Treatment")
Implantation of the stent may be performed only by physicians trained in the application of peripheral stents, their
•
indication, and possible complications.
20
PTA and stent implantation may be performed only at medical facilities which are equipped to perform necessary
•
interventional procedures, in case of complications.
The RESISTANT stent system is indicated for the application following a previous balloon dilatation (usual PTA
•
procedure).
Angioplasty can result in dissection of the vessel and other complications (vasospasm / acute occlusion) which
•
may necessitate additional interventions (e.g. further dilatations, placement of stents).
Pay attention to clinical symptoms during dilatation and stent implantation.
•
Re-dilatation of the arterial segment in which the stent is deployed may become necessary in case of subsequent
•
restenosis. In the case of re-dilatation, ensure that the balloon diameter does not exceed the reference diameter
of the implanted stent. The long-term effects of re-dilatation of an endothelialised stent are unknown at present.
If multiple stents are required, the stent material should be of similar composition to the RESISTANT Stent. The
•
RESISTANT stent is composed of a nickel-titanium alloy. Never implant stents of different materials directly
next to or within one another (danger of formation of galvanic elements).
When the catheter is deployed in the vascular system, it should only be manipulated under radiographic monitor-
•
ing.
Do not try to reposition a partially placed stent. This can result in severe vascular damage.
•
Should hindrances occur while manipulating the RESISTANT stent system, determine the cause of the hin-
•
drances before continuing the procedure.
Use of mechanical atherectomy or laser catheters in the proximity of stent is not recommended.
•
Additional materials are required for application of the system. Refer to the respective usage information for
•
these materials and ensure they are compatible with the RESISTANT stent system.
Should it be necessary to use the guide wire for subsequent artery / lesion access, leave the guide wire in place
•
and remove all other system components.
If several overlapping stents are to be used, it is to be noted that the intersection area is as short as possible and
•
does not lie in sites of strong vascular curvature. The effects of overlapping stents are not known to date.
8.1 RESISTANT Stent System Handling - Precautions
Prior to opening, check the inner sterile package for damage that could impact on sterility.
•
Do not allow the RESISTANT stent system to come in contact with organic solvents, disinfectants, or the like,
•
as this may lead to damage.
For Luer lock connections, ensure that only suitable components are connected to one another and that the con-
•
nections are sealed sufficiently. Ensure that none of the connections were transposed.
8.2 Stent Placement - Precautions
Implanting a stent may lead to dissection of the blood vessel distal and / or proximal to the stent and cause acute
•
vascular occlusion requiring additional intervention (further dilatation, placement of additional stents, etc.).
When treating multiple lesions, the distal lesion should be stented first, followed by stenting of the proximal
•
lesion. Placing the stents in this order will preclude the need to cross the proximal stent when placing the distal
stent and will reduce the risk of displacing the proximal stent.
Do not expand the stent if it is not properly positioned in the blood vessel (please observe the warning instructions
•
for stent/system removal). Completely or partly expanded stent cannot be repositioned.
Besides the stent, the three radiopaque markers at the stent ends facilitate positioning.
Placement of a stent at vessel branchings has the potential to compromise side branch patency.
•
Stent retrieval methods (e.g., use of additional wires, snares and / or forceps) may result in additional trauma to
•
the vascular vessel system and / or the vascular access site. Complications may include bleeding, haematoma
and / or pseudoaneurysms.
21