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• VASCADE should be stored at room temperature (15° – 25°C), otherwise proper device performance may be affected.
NOTE: The safety and effectiveness of the device have not been evaluated in the following patients:
•
Less than 18 years of age.
•
Pregnant and/or lactating women.
•
Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids.
Known significant coagulation defect/bleeding disorders such as thrombocytopenia (platelet count < 100,000/mm³),
•
thrombasthenia, haemophilia, von Willebrand's disease or anaemia (haemoglobin < 10 g/dL and haematocrit < 30%).
Previous vascular grafts or surgery at the target vessel access site.
•
Symptomatic ipsilateral lower extremity ischaemia.
•
Femoral vessel lumen less than 6 mm in diameter.
•
Length of tissue tract (distance between the anterior vessel wall and skin) estimated to be less than 2.5 cm.
•
Fibrinogen level < 150 mg/dL if the patient received a fibrinolytic agent.
•
Extreme morbid obesity (BMI > 45 kg/m²) or underweight (BMI < 20 kg/m²).
•
A notice from the user and/or patient that any serious incident has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the Member State in which the user and/or patient is established.
Complications may occur and may be related to the endovascular procedure or the vascular closure. They include, but are not
limited to:
• Allergic response
• Arteriovenous fistula
• Bleeding from the puncture site
• Bruising at the puncture site
• Death
• Deep vein thrombosis
• Device failure/malfunction
• Oedema
• Embolisation (of thrombus, air,
calcific debris, or device)
IFU 5686 AE, 2024-04
Special Patient Populations
Serious Incident Reporting
Adverse Events
• Haematoma
• Infection
• Inflammatory response
• Intimal tear/dissection
• Laceration of the vessel wall
• Lower extremity ischaemia
• Oozing from the puncture site
• Perforation of the vessel wall
• Peripheral nerve injury
• Pseudoaneurysm
• Pulmonary embolism
• Puncture site pain
• Retroperitoneal bleeding
• Superficial vein thrombosis
• Vascular injury
• Vasovagal response
• Vessel occlusion
• Vessel thrombus
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