AB9U12150090

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<h2>Indications, Safety, and Warnings</h2> <h2>Indications for use</h2> <p>The Abre™ venous self-expanding stent system is intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.</p> <h3>Cautions</h3> <ul> <li>This device was designed for single use only. Do not reuse, reprocess, or resterilize this device. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device or create a risk of contamination, which could result in patient injury, illness, or death.</li> <li>If unusually high resistance is encountered when advancing the Abre™ delivery system over the guidewire, assess the cause of the resistance before proceeding.</li> <li>If high resistance is felt when initially rotating the thumbwheel, do not force deployment. Carefully withdraw the system and do not use it.</li> <li>Do not use in patients with a total venous occlusion that cannot be dilated to allow passage of the guidewire.</li> <li>Do not use the device with contralateral access.</li> <li>Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures.</li> </ul> <h3>Contraindications</h3> <ul> <li>Do not use the Abre™ system with patients with known hypersensitivity to nickel titanium (nitinol).</li> <li>Do not use the Abre™ system with 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.</li> <li>Do not use the Abre™ system with patients in whom anticoagulant or antiplatelet therapy is contraindicated.</li> </ul> <h3>Potential complications</h3> <p>The potential adverse events (or complications) that may occur or require intervention with the use of this device include, but are not limited to, the following:</p> <ul> <li>Access failure</li> <li>Access site infection</li> <li>Allergic reaction to contrast medium or procedure medications</li> <li>Allergic reaction to nitinol or other device materials</li> <li>Aneurysm</li> <li>AV fistula</li> <li>Bleeding</li> <li>Bruising</li> <li>Death</li> <li>Device breakage</li> <li>Device maldeployment</li> <li>Edema</li> <li>Embolization</li> <li>Fever</li> <li>Hematoma</li> <li>Hypertension</li> <li>Hypotension, nausea, or other vasovagal response</li> <li>Infection</li> <li>Myocardial infarction, arrhythmia, or other cardiovascular insufficiency</li> <li>Open surgical repair</li> <li>Pain</li> <li>Pseudoaneurysm</li> <li>Renal insufficiency or renal failure (new or worsening)</li> <li>Respiratory distress or pulmonary embolism</li> <li>Sepsis</li> <li>Stent fracture</li> <li>Stent malapposition</li> <li>Stent malposition</li> <li>Stent migration</li> <li>Stroke, paradoxical embolism, transient ischemic attack, or intracerebral hemorrhage</li> <li>Tissue necrosis</li> <li>Venous occlusion, restenosis, or thrombosis, within or outside of stented segment</li> <li>Vessel damage, including intimal injury, dissection, perforation, or rupture</li> </ul> <h3>MRI safety information</h3> <p><b>MRI conditional</b></p> <p>Nonclinical testing demonstrated that the Abre™ stent in single and overlapped conditions is MR Conditional for stents up to 150 mm.</p> <p>A patient with this device can be scanned safely, immediately after stent placement, under the following conditions:</p> <ul> <li>Static magnetic field of 1.5 Tesla or 3.0 Tesla</li> <li>Maximum spatial gradient magnetic field of 4000 Gauss/cm or less (40 T/m)</li> <li>Maximum MR system-reported, whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode)</li> </ul> <p>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.</p> <p><b>MRI-related temperature rise</b></p> <p>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.</p> <p>It is recommended that patients register conditions under which the implant can be scanned safely with the MedicAlert Foundation (<a href="https://www.medicalalert.org/">medicalert.org</a>) or equivalent organization.</p> <p><b>Artifact information</b></p> <p>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.</p>

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