Warning Instructions For Removal Of The Resistant Stent System; Precautions Following Implantation; Restenosis Treatment - Precautions; Patient Information From The Physician - Eucatech Resistant Gebrauchsanweisung

The RESISTANT stent system is indicated for use after a previous PTA or that of another suitable lesion prepara-
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tion method. The RESISTANT stent system is indicated only for the peripheral vascular system.
An unexpanded stent may be inserted only once into the arteries. An unexpanded stent may not be inserted through
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the distal end of the guide catheter or insert equipment into the vessel and retracted back into the guide catheter or
insert equipment as the stent may be damaged.
Without a preceding PTA, the RESISTANT stent system may be implanted only if there is a patient and lesion
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indication for this procedure.
We recommend observing the current medical association guidelines and recommendations regarding the use of
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peripheral stents.
8.3 Warning instructions for removal of the RESISTANT Stent System
Should unusual resistance be felt at any time during lesion access or removal of the RESISTANT stent system, the
entire system should be removed as a single unit.
When removing the RESISTANT stent system as a single unit:
Do not retract the RESISTANT stent system through the guide catheter or the insert equipment.
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Insert the guide wire distally into the arteries as far as is safely possible.
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Failure to follow these steps and / or application of excessive force to the RESISTANT stent system can result in the loss
of or damage to the stent and / or the components of 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.
8.4 Precautions following implantation
Particular care must be exercised when crossing a newly deployed stent with a guide wire to avoid disrupting the stent
geometry. The same applies to the use of therapeutic, diagnostic, or protective materials in this area.
Magnetic resonance imaging (MRI) may not be performed on patients after stent implantation until the stent has com-
pletely endothelialised (approximately 8 weeks), in order to reduce the risk of migration. The stent may cause artefacts
in MRI scans due to distortion of the magnetic field.
8.5 Restenosis treatment - precautions
When treating restenoses in the arterial segment where the RESISTANT stent is implanted, observe the following pre-
cautions in conjunction with the selected therapeutic procedure.
In the case of re-dilatation, ensure that the stent diameter does not exceed the reference diameter. Stability can no
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longer be guaranteed if the maximum diameter is exceeded or if the stent dilates unevenly. At present there are no
data regarding the long-term results after re-dilatation of an endothelialised RESISTANT Stent.
If implants are used, the implant material should be of a composition similar to the stent already implanted. The
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RESISTANT stent is composed of a nickel-titanium alloy. There are no data at present regarding the interactions
between the RESISTANT stent and stents with a coating, drug coating, or no coating.
When using other procedures to treat restenosis, ensure that the implanted stent is not damaged and that stent
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fragments are not released.
8.6 Patient information from the physician
In some countries, patients who are employed near electrical, magnetic, or electromagnetic fields are required to inform
their employers regarding the implantation of metallic implants, which includes the RESISTANT stent. This is required
so that the employer can decide regarding measures necessary to protect the employee against possible hazards caused
by electrical, magnetic, or electromagnetic fields. Affected employees should be informed by the physician in this
regard.
Additional regulations, if they exist, should also be taken into account.
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9 Individualisation of treatment
The risks and benefits for each individual patient must be carefully weighed before using the RESISTANT stent system.
The patient selection criteria should always include an evaluation of the risk of using therapy with platelet aggregation
inhibitors. Special consideration should be given to patients with recent reflux oesophagitis, active gastritis or peptic
ulcers.
Patients should be examined for previously existing conditions which might increase the risk of intervention (diabetes
mellitus, kidney failure and severe obesity).
The risk of early vessel occlusion for instance, as a result of thrombosis or restenosis, is favoured by a variety of angio-
graphic and therapeutic factors. These include, inter alia, small blood vessel diameter, thrombus formation during the
surgical intervention, delayed run-off and / or dissection following dilatation. In patients who have undergone dilatati-
on, the persistence of a thrombus or evidence of a dissection should be considered as increased risk for occurrence of
an occlusion syndrome. These patients normally require a supplementary drug therapy and should be monitored very
carefully at a sufficiently scaled time interval, in particular, during the first year following dilatation (and / or stent
implantation). In the medical follow-up treatment and monitoring of patients, the current guidelines of the radiological
organisations (ACR: www.acr.org or DRG: www.drg.de) are recommended.
10 Preparation and execution
The following describes the work steps and required material for stent implantation under radiographic monitoring. The
instructions are purely informative in nature and are to be supplemented or adapted by the physician performing the
treatment based on his or her clinical experience.
The RESISTANT stent system shall be applied only after a previous balloon dilatation (usual PTA procedure).
10.1 Aseptic removal
Carefully remove the inner sterile package from the carton and check it for damage that could endanger the sterility
of the product. Remove the RESISTANT stent system under aseptic conditions. Carefully open the sterile package by
pulling apart the paper-like film at the corner indicated from the plastic cover.
Ensure that the system is not bent and does not come in contact with unsterile materials or is contaminated in any other
manner.
10.2 Inspections prior to use
Before using the RESISTANT stent system, carefully remove the packaging and check the system for bends, kinks, and
other damage. Do not use if any defects are noted.
10.3 Material required
The following materials are required for implantation of the RESISTANT stent under radiographic monitoring. These
materials are not part of the RESISTANT stent system scope of delivery.
Material Requirement
Suitable guide catheter / insert The required inner diameter of the guide catheter and / or insert equipment shall
equipment be selected on the basis of the shaft diameter indicated on the labels.
Guide wire Minimum length 175 cm
Diameter for 6F delivery system: Maximum 0.035" (0.89 mm)
Diameter for 5F delivery system: Maximum 0.021" (0.53 mm)
Radiographic contrast agent Recommended:
Contrast agent for angiography
Concentrations and mixtures could impact visibility during radiographic moni-
toring and viscosity.
Torque device Compatible with the selected guide wire.
Guide wire introducer Compatible with the selected guide wire.
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