Indications; Selection Of Resistant Stent System; Contraindications; Potential Complications - Eucatech Resistant Gebrauchsanweisung

If the product is reused, the reprocessed single-use product of eucatech AG may not achieve the required performance
and / or result in an infection of the patient. This may result in a hazard to the health of patients, users or third parties.
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and user.

3 Indications

Criteria for use of RESISTANT Stent System are:
Atherosclerotic de novo lesions
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Restenoses
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Insufficient angioplasty result
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Residual stenosis / stenoses after balloon dilatation(s) >50%
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Dissection with flow blockage
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Recoil in stenosised bypass anastomoses
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Pelvic arterial occlusions
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The RESISTANT stent system is indicated only for the peripheral vascular system.
3.1 Selection of RESISTANT stent system
The diameter of the selected stent system should correspond to the reference vessel diameter in a range between 3.0 mm
and 11.0 mm. Based on the super elasticity of the stent material, the nominal stent diameter should be 0.5 mm to 1.5 mm
above the reference vessel diameter to guarantee optimum vascular support. Select the stent length to ensure sufficient
coverage of the lesion; stent lengths between 20 mm and 100 mm are available. The stent lengths and diameters of the
RESISTANT stent system are indicated on the labels.
Additional materials are required for stent implantation, which are not part of the RESISTANT stent system. Additional
information may be found in section "10.3 Required material".

4 Contraindications

Lesions to vessel bifurcations with one or more side branches.
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Patients with cardiogenic shock.
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Patients for whom therapy with platelet aggregation inhibitors and / or anti-coagulants is contraindicated. This
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includes patients who have undergone major surgery, or an operation is planned in the first four weeks after dilata-
tion that excludes the administration of platelet aggregation inhibitors, an induced delivery, an organ biopsy, or a
puncture of a non-compressible blood vessel within a period of 14 days before this operation. Likewise excluded
are patients with gastrointestinal bleeding, acute cerebrovascular events, bleeding due to diabetic retinopathy, or
other diseases which prohibit anti-coagulation therapy.
Target lesions distal to a stent placed previously.
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Target lesions distal to a higher stenosis which cannot be predilated, or target lesions proximal to untreatable areas
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with significant disease restricting blood flow.
Resistant (fibrotic or calcified) lesions which cannot be predilated (lesions for which complete balloon inflation is
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not possible at specified "rated burst pressure" (RBP)).
The estimated reference diameter of the artery is less than 3.0 mm.
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Lesions to be treated that cannot be covered by a single stent.
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Patients with diffuse vessel diseases in the form of long vessel wall modifications without interim normal vessel
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sections.
Large thrombus and patients with complex vascular disease.
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Patients who show persistent and acute intraluminal thrombosis following a thrombolytic therapy at the lesion site.
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Perforation at the angioplasty site, marked by escape of the contrast agent.
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Aneurysm of the artery to be treated.
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Lesions that do not allow PTA or another interventional technique.
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Patients with significant vascular curvature and / or proximal atherosclerosis who cannot be provided with excel-
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lent support by the guide catheter or the port.
Severe contrast agent allergy.
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Patients with well known hypersensitivity to nickel-titanium alloys.
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All patients diagnosed with a lesion that may prevent correct stent positioning.
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All usual contraindications for a PTA procedure.
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Follow the current medical standard of knowledge.
5 Potential complications
Possible complications which may result from this surgical procedure include:
allergic reaction to anti-coagulants, antithrombotic therapy, contrast agent or stent and / or other materials or drugs
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that are used as part of the procedure
aneurysm
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arterial perforation
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arterial rupture
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arteriovenous fistula
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bleeding complications which may necessitate blood transfusion
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bradycardia
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diarrhoea
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embolism
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fever
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vessel spasm and trauma
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haematoma
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hypotension / hypertonia
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infection
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Intraluminal thrombosis
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ischaemia
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cardiovascular incidents
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entry site complications
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contrast agent reaction / kidney insufficiency or failure
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palpitations
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pseudoaneurysm (femoral)
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respiratory insufficiency
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restenosis in the stent entry segment
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restenosis in the stented segment
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arrhythmias
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stroke / cerebrovascular insult / TIA / cerebral bleeding
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pains
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shock, pulmonary oedema
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side branch occlusions
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stent collapse or breakage
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death
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incomplete stent apposition
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vascular complications which may necessitate vessel repair (also surgical intervention, if required)
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cerebrovascular incidents
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Irrespective thereof, the following represent complications in a PTA and / or stent placement:
Amputation
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Incorrect stent placement
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Dissection or flap formation
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Stent migration
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