AB9T10120090

Image of Abre™ venous deployed stent and delivery system.

Indications, Safety, and WarningsIndications for useThe Abre™ venous self-expanding stent system is intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.Cautions

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.

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.

Do not use in patients with a total venous occlusion that cannot be dilated to allow passage of the guidewire.

Do not use the device with contralateral access.

Stenting across a major branch could cause difficulties during future diagnostic or therapeutic procedures.

Contraindications

Do not use the Abre™ system with patients with known hypersensitivity to nickel titanium (nitinol).

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.

Do not use the Abre™ system with patients in whom anticoagulant or antiplatelet therapy is contraindicated.

Potential complicationsThe 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:

Access failure

Access site infection

Allergic reaction to contrast medium or procedure medications

Allergic reaction to nitinol or other device materials

Aneurysm

AV fistula

Bleeding

Bruising

Death

Device breakage

Device maldeployment

Edema

Embolization

Fever

Hematoma

Hypertension

Hypotension, nausea, or other vasovagal response

Infection

Myocardial infarction, arrhythmia, or other cardiovascular insufficiency

Open surgical repair

Pain

Pseudoaneurysm

Renal insufficiency or renal failure (new or worsening)

Respiratory distress or pulmonary embolism

Sepsis

Stent fracture

Stent malapposition

Stent malposition

Stent migration

Stroke, paradoxical embolism, transient ischemic attack, or intracerebral hemorrhage

Tissue necrosis

Venous occlusion, restenosis, or thrombosis, within or outside of stented segment

Vessel damage, including intimal injury, dissection, perforation, or rupture

MRI safety informationMRI ConditionalNonclinical 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 riseUnder 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 (medicalert.org) or equivalent organization.Artifact informationIn 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.UC202103705dEN

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