VICI Venous Stent™ Stent System and Vici RDS Venous Stent System Brief Summary

Prescriptive Information

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 and VICI RDS Venous Stent System are both indicated for improving luminal diameter in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.

CONTRAINDICATIONS

The VICI Venous Stent System and VICI RDS Venous Stent System are both 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.

WARNINGS

  • 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 and the VICI RDS™ VenousStent have not been studied.
  • Stenting in the region of the inguinal ligament in some patients may result in an increased risk instent fracture.
  • For compressive lesions in the CIV, the VICI VENOUS STENT and the VICI RDS Venous Stentdo not need to be extended across the Inferior Vena Cava (IVC). Physicians should extend the stentup to 1.0cm beyond the compressive lesion
  • The VICI VENOUS STENT System and the VICI RDS Venous Stent system have not beenevaluated for contralateral access. This access approach is not recommended.
  • Access: This device is designed for ipsilateral femoral or popliteal and jugular access only. Accesssite 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 or VICI RDS 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 measureddiameter of the surrounding “normal” vein.
    • In postthrombotic diseased veins, target veins should be pre-dilated to the reference veindiameter.
    • In non-thrombotic lesions, size stent diameter to ensure stent engagement in area of centralfocal compressive lesion (e.g. vessel crossing) and adequate wall apposition in peripheralnormal veins.
    • Dilated veins peripheral to stenosis are not normal veins, and therefore should not be usedto measure reference vein diameter and stent diameter selection.
    • Excessive oversizing of stents has been reported to contribute to post-operative patientpain.
    • The stented length should be at least 1cm longer than the obstructive venous lesion (aminimum of 0.5cm centrally and 0.5cm peripherally).
  • Stent Deployment: The VICI VENOUS STENT and the VICI RDS™ Venous Stent cannot berecaptured into the delivery system once it is partially deployed. Attempted recapture may result indamage to the vein.
    • Careful attention should be used to avoid stretching or compressing the stent duringdeployment, as this may increase risk of stent fracture. During deployment, maintain theposition of the Inner Shaft Hub.
  • Allergy Information: The VICI VENOUS STENT and the VICI RDS VENOUS STENT areconstructed 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 mayhave an allergic reaction to this device.

PRECAUTIONS

  • Sizing: The minimally acceptable sheath French size is printed on the package label. Do notattempt to pass the stent delivery system through a smaller size introducer sheath than indicatedon the label.
  • Thrombus: If thrombus is noted once the stent is expanded, thrombolysis and/or PTA should beconsidered.
  • Procedural Complications: In the event of procedural complications such as infection,pseudoaneurysms, or fistula formation, surgical removal of the stent may be required.

MAGNETIC RESONANCE IMAGING (MRI)

MRI Safety Information

  • Non-clinical testing has demonstrated that the VICI VENOUS STENT System and the VICI RDS™ VENOUSSTENT System are Magnetic Resonance (MR) Conditional.
  • A patient with the VICI VENOUS STENT or VICI RDS VENOUS STENT can be scanned safely, immediatelyafter placement, in an MR system meeting the following conditions:
    • Static magnetic field of 1.5 T or 3.0 T only.
    • Maximum spatial gradient magnetic field of 4,000gauss/cm (40T/m).
    • Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2W/kg (NormalOperating Mode).
  • Under the scan conditions defined, the VICI VENOUS STENT and VICI RDS VENOUS STENT are expected toproduce a maximum temperature rise of 6°C after 15 minutes of continuous scanning.
  • In non-clinical testing, the image artifact caused by the VICI VENOUS STENT and VICI RDS VENOUS STENTextend approximately 5mm from this device when imaged with a gradient echo pulse sequence and a 3.0 T MRsystem. The lumen of the VICI VENOUS STENT or VICI RDS VENOUS STENT cannot be visualized on thegradient echo or T1-weighted, spin echo pulse sequences.

ADVERSE EVENTS

Placement of the VICI VENOUS STENT or VICI RDS™ VENOUS STENT should not be attempted byphysicians who are not familiar with the possible complications that may occur during interventionalendovascular procedures. Potential device or procedure-related complications of interventionalendovascular procedures include, but are not limited to:

  • Abscess
  • Access site complications including: bleeding, pain, tenderness, pseudoaneurysm, hematoma, nerve or vessel damage, or infection
  • Allergic or hypersensitivity reactions (drug, contrast, device or other)
  • Amputation
  • Aneurysm
  • Arteriovenous fistula formation and rupture
  • Back pain
  • Cerebrovascular dysfunction and/or stroke
  • Death
  • Embolization
  • Entanglement of delivery system in deployed stent
  • Fever
  • GI bleeding
  • Hypotension/hypertension
  • 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
  • Restenosis
  • Sepsis/Infection
  • Stent fracture
  • Stent migration, misplacement/jumping, or embolization
  • Stent occlusion
  • Stent thrombosis
  • Thrombophlebitis
  • Tissue ischemia/necrosis
  • Vasospasm
  • Vein thrombosis
  • Venous congestion
  • Venous occlusion
  • Vessel injury, examples include dissection, intimal tear, rupture or perforation
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