INDICATIONS, SAFETY, AND WARNINGS Abre Venous Self-expanding Stent System

Note: Safety information provided is for the U.S. Please refer to your region’s Instructions for Use for specific details.

INDICATIONS FOR USE

The Abre™ venous self-expanding stent system is intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.


CAUTIONS

  • The device is provided sterile, for single use only. Do not reprocess or resterilize. Reprocessing or resterilizing could increase the risk of patient infection and the risk of compromised device performance.
  • If unusually high resistance is encountered when advancing the Abre delivery system over the guidewire, assess the cause of the resistance before proceeding.
  • If high resistance is felt when initially rotating the thumbwheel, do not force deployment. Carefully withdraw the system and do not use it.

CONTRAINDICATIONS

  • Do not use the Abre system with patients in whom anticoagulant or antiplatelet therapy is contraindicated.
  • Do not use the Abre system with patients with known hypersensitivity to nickel titanium (nitinol).

POTENTIAL COMPLICATIONS

  • Access failure
  • Access site infection
  • Allergic reaction to contrast medium or procedure medications
  • Allergic reaction to nitinol or other device materials
  • Arrhythmia
  • AV fistula
  • Bleeding
  • Bruising
  • Death
  • Device breakage
  • Device maldeployment
  • Edema
  • Fever
  • Hematoma
  • Hypotension, nausea, or other vasovagal response
  • Infection
  • Myocardial infarction
  • Pain
  • Pseudoaneurysm
  • Pulmonary embolism
  • Renal insufficiency/renal failure (new or worsening)
  • Sepsis
  • Stent fracture
  • Stent malapposition
  • Stent malposition
  • Stent migration
  • Stroke/paradoxical embolism/transient ischemic attack/intracerebral hemorrhage
  • Tissue necrosis
  • Transfusion reaction following blood transfusion for treatment of major bleeding
  • Vessel damage, including perforation or rupture
  • Venous occlusion/thrombosis, within or outside of stented segment

MRI SAFETY INFORMATON

MRI Conditional

Nonclinical testing demonstrated that the Abre stent in single and overlapped conditions is MR Conditional for stents up to 150 mm.

A patient with this device can be scanned safely, immediately after stent placement, under the following conditions:

  • Static magnetic field of 1.5 Tesla or 3.0 Tesla
  • Maximum spatial gradient magnetic field of 4000 Gauss/cm or less (40 T/m)
  • Maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode)

MR image quality may be compromised if the area of interest is in
the exact location or close to the position of the Abre stent.

MRI-related Temperature Rise

Under the scan conditions as defined in the previous section, "MR Conditional," the Abre stent is expected to produce a maximum temperature rise less than or equal to 5.2 C after 15 minutes of continuous scanning (per pulse sequence). The effect of temperature rise in the MRI environment for stents with fractured struts is not known.

It is recommended that patients register conditions under which the implant can be scanned safely with the MedicAlert Foundation (www.medicalert.org) or equivalent organization.

Artifact Information

In nonclinical testing, the maximum artifact size as seen on the gradient echo pulse sequence at 3.0 Tesla extends approximately 5 mm, relative to the size and shape of the Abre stent. The lumen of the stent can be visualized using the T1-weighted spin echo pulse sequence and the T1-weighted gradient echo pulse sequence at 3.0 Tesla.