VICI Venous Stent™ Stent System Brief Summary
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.
INTENDED USE/INDICATIONS FOR USE
The VICI Venous Stent System is contraindicated for use in:
- Patients who are judged to have a lesion that prevents complete inflation of a balloon dilatation catheter or proper placement of the stent or the stent delivery system.
- Patients who cannot receive intraprocedural anti-coagulation therapy.
- Safety and efficacy for stenting outside of the Common Iliac Vein (CIV), External Iliac Vein (EIV) and Common Femoral Vein (CFV) with the VICI VENOUS STENT has not been studied.
- Stenting in the region of the inguinal ligament in some patients may result in an increased risk in stent fracture.
- For compressive lesions in the CIV, the VICI VENOUS STENT does not need to be extended across the Inferior Vena Cava (IVC). Physicians should extend the stent up to 1.0cm beyond the compressive lesion
- The VICI VENOUS STENT System has not been evaluated for contralateral access. This access approach is not recommended.
- Access: This device is designed for ipsilateral femoral or popliteal and jugular access only. Access site should allow for adequate assessment of disease and inflow.
- Sizing: To eliminate risk of stent migration or stent movement, do not deploy the VICI VENOUS STENT unless the target diameter has been properly measured. Improper stent size selection can lead to stent migration or inadvertent stent movement.
- The diameter of the stent should be 1mm - 2mm greater than (“over”) the measured diameter of the surrounding “normal” vein.
- In postthrombotic diseased veins, target veins should be pre-dilated to the reference vein diameter.
- In non-thrombotic lesions, size stent diameter to ensure stent engagement in area of central focal compressive lesion (e.g. vessel crossing) and adequate wall apposition in peripheral normal veins.
- Dilated veins peripheral to stenosis are not normal veins, and therefore should not be used to measure reference vein diameter and stent diameter selection.
- Excessive oversizing of stents has been reported to contribute to post-operative patient pain.
- The stented length should be at least 1cm longer than the obstructive venous lesion (a minimum of 0.5cm centrally and 0.5cm peripherally).
- Stent Deployment: The VICI VENOUS STENT cannot be recaptured into the delivery system once it is partially deployed. Attempted recapture may result in damage to the vein.
- Careful attention should be used to avoid stretching or compressing the stent during deployment, as this may increase risk of stent fracture. During deployment, maintain the position of the Inner Shaft Hub.
- Allergy Information: The VICI VENOUS STENT is constructed of a nickel-titanium alloy (Nitinol) and tantalum, which are generally considered safe; however, patients who are allergic to these materials or who have a history of metal allergies may have an allergic reaction to this device.
- Sizing: The minimally acceptable sheath French size is printed on the package label. Do not attempt to pass the stent delivery system through a smaller size introducer sheath than indicated on the label.
- Thrombus: If thrombus is noted once the stent is expanded, thrombolysis and/or PTA should be considered.
- Procedural Complications: In the event of procedural complications such as infection, pseudoaneurysms, or fistula formation, surgical removal of the stent may be required.
Placement of the VICI VENOUS STENT should not be attempted by physicians who are not familiar with the possible complications that may occur during interventional endovascular procedures. Potential device or procedure-related complications of interventional endovascular procedures include, but are not limited to:
- Access site complications including: bleeding, pain, tenderness, pseudoaneurysm, hematoma, nerve or vessel damage, or infection
- Allergic or hypersensitivity reactions (drug, contrast, device or other)
- Arteriovenous fistula formation and rupture
- Back pain
- Cerebrovascular dysfunction and/or stroke
- Entanglement of delivery system in deployed stent
- GI bleeding
- Myocardial infarction, ischemia, angina, or other cardiovascular disturbance
- Need for urgent intervention or surgery
- Obstruction of venous tributaries
- Organ failure
- Pneumothorax or respiratory distress, pneumonia and/or atelectasis
- Renal failure
- Stent fracture
- Stent migration, misplacement/jumping, or embolization
- Stent occlusion
- Stent thrombosis
- Tissue ischemia/necrosis
- Vein thrombosis
- Venous congestion
- Venous occlusion
- Vessel injury, examples include dissection, intimal tear, rupture or perforation