VICI VENOUS STENT System

• 2 recalls, same reason

  • Ongoing Z-1591-2021 FDA Class I ·initiated 12 Apr 2021
  • Ongoing Z-1592-2021 FDA Class I ·initiated 12 Apr 2021

  The firm has received reports of stent migration after implantation

Generic name

Stent, iliac vein

FDA applicant

Boston Scientific Corporation

PMA number

P180013 ↗

FDA product code

QAN

Device class

Class III

Advisory committee

Cardiovascular

FDA decision

APPR Approved

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• What is the primary clinical use of the VICI Venous Stent System, and how does it function in the body?

  The VICI Venous Stent System is designed to improve blood flow by maintaining an open lumen in the iliofemoral veins, which are critical for venous return from the lower body. It is intended for treating symptomatic venous outflow obstruction, a condition where narrowed or blocked veins restrict blood flow, often causing swelling, pain, or ulcers. The self-expanding, laser-cut nitinol stent mechanically widens the vein to restore proper diameter and alleviate obstruction.

• Is the VICI Venous Stent System intended for reuse, or is it meant to be used only once?

  The VICI Venous Stent System is explicitly labeled for single-use only. It is supplied as a combination of an implantable endoprosthesis and a delivery system, and reuse is not supported by the manufacturer to ensure sterility and functionality. Discard any unused components after deployment.

• What storage and handling precautions must be followed to preserve the device’s sterility and performance?

  The device must be stored and handled according to the manufacturer’s guidelines to maintain sterility and functionality. Since it is single-use, avoid contamination by keeping it in its original packaging until immediate use. Exposure to moisture, extreme temperatures, or mechanical stress could compromise the stent’s integrity or delivery system. Always follow the included instructions for proper storage conditions.

• Can the VICI Venous Stent System be used in patients who require MRI scans, or are there restrictions?

  The VICI Venous Stent System is not intended for MRI use. The nitinol material and design may interact with magnetic fields, posing risks to the patient or interfering with imaging. If MRI is clinically necessary, alternative imaging modalities should be considered, and the manufacturer’s guidelines should be consulted for further restrictions.

• How is the device’s regulatory approval categorized, and what does this mean for clinicians or purchasers?

  The VICI Venous Stent System is classified as a Class III device under FDA regulations and holds a Premarket Approval (PMA) designation (PMA #P180013). This classification indicates it carries higher risk and requires rigorous pre-market evaluation to ensure safety and effectiveness. Clinicians and purchasers can rely on this approval for its intended use in treating symptomatic venous outflow obstruction in the iliofemoral veins, as outlined in the FDA’s authorization.