Venovo Venous Stent System

• 3 recalls, same reason

  • Ongoing Z-1897-2021 FDA Class II ·initiated 14 Dec 2020
  • Ongoing Z-1899-2021 FDA Class II ·initiated 14 Dec 2020
  • Ongoing Z-1898-2021 FDA Class II ·initiated 14 Dec 2020

  Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.

Generic Name

Stent, iliac vein

PMA Number

P180037 ↗

FDA Product Code

QAN

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

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See all devices from Bard Peripheral Vascular, Inc. →

• What specific venous obstructions does the Venovo Venous Stent System address, and how does it help relieve symptoms?

  The Venovo Venous Stent System is designed to treat symptomatic iliofemoral venous outflow obstruction, which refers to blockages in the iliac veins (the large veins carrying blood from the legs back to the heart). By placing the stent percutaneously within these veins, it restores proper blood flow and alleviates common symptoms like leg swelling, chronic pain, or venous ulcers caused by the obstruction.

• Is the Venovo Venous Stent System intended for reuse, or is it meant to be used once and then discarded?

  The Venovo Venous Stent System is explicitly labeled as intended for **single-use only**. This means it should not be reused after deployment, as reuse could compromise sterility and device integrity, potentially leading to complications.

• What sizes and configurations are available for the Venovo Venous Stent System, and how do I identify them?

  The Venovo Venous Stent System comes in multiple sizes and configurations tailored for iliac vein placement. Each variant is associated with a unique **FEI number** (e.g., 3002807314, 3009526575), which corresponds to specific diameters and lengths. These codes help clinicians select the appropriate stent for the patient’s anatomy.

• How should the Venovo Venous Stent System be stored to maintain its sterility and functionality?

  Since the Venovo Venous Stent System is supplied **sterile**, it must be stored and handled according to standard sterile medical device protocols. This includes keeping it in its original packaging, protecting it from contamination, and adhering to manufacturer guidelines to preserve its integrity before use.

• What type of professional expertise is required to deploy the Venovo Venous Stent System?

  The Venovo Venous Stent System requires **professional medical supervision** for deployment. It is placed via **fluoroscopic guidance**, meaning an experienced interventional radiologist or vascular specialist should perform the procedure to ensure proper positioning and minimize risks.