REBEL Indications, Safety, and Warnings

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REBEL™ Platinum Chromium Coronary Stent System

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE:

The REBEL Coronary Stent System is indicated for improving coronary luminal diameter in patients with de novo lesions ≤ 28 mm in length in native coronary arteries with a reference vessel diameter (RVD) of ≥ 2.25 mm to ≤ 4.50 mm.

CONTRAINDICATIONS:

Use of the REBEL Stent System is contraindicated in patients with the following:

• Known hypersensitivity to platinum, the platinum chromium alloy, or similar alloy types such as stainless steel.
• Known severe reaction to contrast agents that cannot be adequately premedicated prior to the REBEL Stent placement procedure.

Coronary artery stenting is contraindicated for use in the following:

• Patients who cannot receive recommended anti-platelet and/or anticoagulant therapy.
• Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device.

WARNINGS:

• This product should not be used in patients who are not likely to comply with recommended anti-platelet therapy.
• The use of this product carries the risks associated with coronary artery stenting, including: stent thrombosis, vascular complications, and/or bleeding events.

PRECAUTIONS:

General Precautions

• Only physicians who have received adequate training should perform implantation of the stent.
• Stent placement should only be performed at hospitals where emergency coronary artery bypass graft (CABG) surgery is readily available.
• Subsequent stent blockage may require repeat dilatation of the arterial segment containing the stent. The long-term outcome following repeat dilatation of previously implanted stents is not well characterized.
• Before withdrawing the stent delivery system, visually confirm complete balloon deflation by fluoroscopy.

Pre- and Post-Procedure Anti-platelet Regimen

Administer appropriate anticoagulant/anti-platelet therapy according to current medical guidelines. The 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention (PCI) are provided at the following website: https://content.onlinejacc.org/cgi/content/full/j.jacc.2011.08.007v1.

Longitudinal Stent Deformation

Longitudinal stent deformation is a recognized potential failure mode of thin strut coronary stents. Although a rare event, longitudinal stent deformation may result in adverse clinical events and/or the need for additional treatment including repeat dilation of the implanted stent, placement of a second stent and/or surgical intervention. Implantation techniques that may reduce the likelihood of procedure related complications, including stent deformation, are described in the appropriate sections of this DFU.

Brachytherapy

The safety and effectiveness of the REBEL stent in patients with prior brachytherapy of the target lesion have not
been established.

Use in Conjunction with Other Procedures

The safety and effectiveness of using mechanical atherectomy devices (directional atherectomy catheters or rotational atherectomy catheters) or laser angioplasty catheters in conjunction with REBEL stent implantation have not been established.

Use in Special Populations

The safety and effectiveness of the REBEL stent have not been established in the following patient populations:

• Patients with vessel thrombus at the lesion site.
• Patients with coronary artery reference vessel diameters < 2.25 or > 4.50 mm.
• Patients with coronary artery lesions longer than 28 mm or requiring more than one REBEL stent.
• Patients with lesions located in the saphenous vein grafts, in the left main coronary artery, ostial lesions, or lesions located at a bifurcation.
• Patients with diffuse disease or poor flow distal to the identified lesions.
• Patients with tortuous vessels (> 60 degrees) in the region of the obstruction or proximal to the lesion.
• Patients with a recent acute myocardial infarction where there is evidence of thrombus or poor flow.
• Patients with in-stent restenosis.
• Patients with moderate or severe calcification in the lesion or a chronic total occlusion.
• Patients with 3 vessel disease.

Magnetic Resonance Imaging (MRI)

Non-clinical testing has demonstrated that the REBEL stent is MR Conditional for single and overlapped conditions up to 74 mm. A patient with this device can be safely scanned in a Magnetic Resonance system meeting the following conditions:

• Static magnetic field of 3.0 and 1.5 Tesla only
• Maximum spatial gradient magnetic field of 2200 gauss/cm (22 T/m)
• Maximum Magnetic Resonance system reported, whole body averaged specific absorption rate (SAR) of < 2 W/kg (Normal Operating Mode)

Under the scan conditions defined above, the REBEL stent is expected to produce a maximum temperature rise of 2.6ºC after 15 minutes of continuous scanning.

Stent Handling

• Note product “Use By” date.
• The premounted REBEL stent and its delivery system are designed for use as a unit.
• Use only the appropriate balloon inflation media. DO NOT USE air or any gas medium to inflate the balloon.
• In the event the REBEL stent is not deployed, do not use the product and contact your local Boston Scientific Representative for return information.

Stent Placement

• An unexpanded stent should be introduced into the coronary arteries one time only. An unexpanded stent should not be subsequently moved in and out through the distal end of the guide catheter as stent damage or stent dislodgment from the balloon may occur.
• Do not expand the stent if it is not properly positioned in the vessel.
• Do not exceed rated burst pressure as indicated on product
• Placement of the stent has the potential to compromise side branch patency if stenting near a side branch.
• Implanting a stent may lead to dissection of the vessel distal and/or proximal to the stented portion, and may cause acute closure of the vessel requiring additional intervention (e.g., CABG, further dilation)
• When treating multiple lesions, the distal lesion should generally be stented first, followed by stenting of the more proximal lesion(s).
• If unusual resistance is felt at any time during lesion access before stent implantation, the stent delivery system and the guide catheter should be removed as a single unit under direct visualization using fluoroscopy.
• Do not attempt to pull an unexpanded stent back into the guide catheter, as stent damage or stent dislodgment from the balloon may occur.
• Stent retrieval methods (use of additional wires, snares, and/or forceps) may result in additional trauma to the vascular site.

Potential Adverse Events

Potential adverse events (in alphabetical order) which may be associated with the use of a coronary stent in native coronary arteries include but are not limited to:

• Abrupt closure
• Allergic reaction (including to medications, contrast, stent materials)
• Aneurysm (coronary)
• Angina
• Arrhythmias, including ventricular fibrillation and ventricular tachycardia
• Arteriovenous fistula
• Bleeding
• Cardiac tamponade
• Cardiogenic shock
• Cardiomyopathy
• Death
• Emboli (including air, tissue, thrombus, plaque, or device materials)
• Heart failure
• Hematoma
• Hemorrhage
• Hypotension/hypertension
• Infection, local and/or systemic
• Ischemia, myocardial
• Myocardial infarction
• Pain
• Pericardial effusion
• Pseudoaneurysm, femoral
• Pulmonary edema
• Renal insufficiency or failure
• Respiratory failure
• Restenosis of stented segment
• Shock
• Stent embolization
• Stent fracture
• Stent migration
• Stent thrombosis and/or vessel occlusion
• Stroke/cerebrovascular accident/transient ischemic attack
• Total occlusion of coronary artery
• Vessel spasm
• Vessel injury (including dissection, perforation, rupture or trauma)

There may be other potential adverse events that are unforeseen at this time.