Indication for Use:

The Revello™ Vascular Covered Stent is indicated for the treatment of atherosclerotic lesions in the common and external iliac arteries. Contraindications: There are no known contraindications for the Revello™ Vascular Covered Stent.

Warnings: This device should be used only by physicians who are familiar with the complications, side effects, and hazards commonly associated with endovascular procedures.

• The Revello™ Vascular Covered Stent device is supplied STERILE (by ethylene oxide gas) and is intended for SINGLE USE ONLY. DO NOT RESTERILIZE AND/ OR REUSE the device. Reuse, resterilization, reprocessing, and/or repackaging may create a risk to the patient or user; may lead to infection or compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure; and/or may lead to injury, illness, or death of the patient. Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long and small lumina, joints, and/or crevices between components – are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death.
• DO NOT use the device if the sterile packaging has been damaged or unintentionally opened prior to use.
• DO NOT use the device after the “Use By” date specified on the label.
• Use of the device is not recommended under the following conditions, as safety and performance have not been established. The device should not be used in these situations: Patients with uncorrectable coagulation disorders; Patients who cannot be adequately pre-medicated; Patients with known allergy or sensitivity to contrast media; Patients with known hypersensitivity to nickel-titanium or tantalum; Cases where full expansion of an appropriately sized PTA balloon catheter could not be achieved during pre-dilation with an angioplasty balloon; Patients unable to receive the recommended antiplatelet and/or anticoagulation therapy; Patients with functionally relevant arterial obstruction of the inflow path, poor outflow, or no distal runoff; Target lesions with a large amount of adjacent acute or subacute thrombus; Lesions that would prevent a surgical salvage bypass procedure.
• The safety and effectiveness of the device when placed across an aneurysm or a pseudoaneurysm has not been evaluated.
• The safety and effectiveness of the device when placed across a previously placed bare metal stent has not been evaluated.
• The safety and effectiveness of the device when used in pediatrics has not been evaluated.
• The safety and effectiveness of the device when used in aortic rupture repair has not been evaluated. The safety and effectiveness of the device when placed as a branch for an abdominal aortic aneurysm (AAA) device has not been evaluated.
• This device is not suitable to restore and maintain the venous outflow of hemodialysis access circuits.
• The long-term outcomes following repeat dilatation of endothelialized covered stents are unknown.
• The covered stent is not designed for repositioning or recapturing.
• If multiple covered stents are placed in an overlapping fashion, they should be of similar composition (i.e., nitinol [nickel-titanium alloy]).
• In case of overlapping devices, approximately 10 mm of overlap between devices is recommended.
• It is recommended to use the 80 cm working length device for ipsilateral procedures. The longer working length of the 135 cm device may potentially be challenging for the user to keep straight for ipsilateral procedures. Failure to keep the device straight may impede the optimal deployment of the implant. Precautions: The covered stent (implant) cannot be repositioned after total or partial deployment.
• Once partially or fully deployed, the covered stent cannot be retracted or remounted onto the delivery system.
• If unusual resistance is met during covered stent system introduction, the system should be removed and another covered stent system should be used.
• During covered stent release, DO NOT hold any segment of the 44 cm long distal catheter assembly as it must be free to move and slide into the blue stability sheath.
• Do not pinch on the blue stability sheath since this may interfere with covered stent deployment and may lead to misplacement.
• The covered stent cannot be post dilated beyond its labelled diameter.
• Higher deployment force may be encountered with longer length covered stents.
• During system flushing, observe that saline exits at the delivery system tip.
• The delivery system is not designed for use with power injection systems.
• Recrossing a partially or fully deployed covered stent with adjunct devices must be performed with caution.
• Keep the device as straight as possible following removal from the packaging and while inserted in the patient. Failure to do so may impede the optimal deployment of the implant.
• Prior to and during covered stent deployment, remove slack from the delivery system catheter outside the patient by gently holding (without pinching) the stability sheath and keeping it straight and gently tensioned.
• If excessive force is felt during covered stent deployment, DO NOT force the delivery system. Remove the delivery system and replace with a new unit.
• DO NOT attempt to break, damage, or disrupt the covered stent after placement.
• The GeoAlign™ Marking System is designed to be used as an additional reference tool to accompany the interventionalist‘s standard operation procedure. The use of fluoroscopic imaging is recommended following positioning of the catheter to the target lesion and prior to covered stent deployment or balloon inflation.
• If the GeoAlign™ location reference is on the brown moving sheath (Figure 9), the location reference will move relative to the introducer hub and stability sheath as soon as covered stent deployment has been initiated. DO NOT try to re-align the location reference after covered stent deployment has been initiated.
• The blue stability sheath should remain stationary relative to the introducer and gently tensioned throughout deployment.
• Prior to covered stent implantation, refer to the sizing table (Table 4) and read the Instructions for Use.
• The delivery system is not intended for any use other than covered stent deployment.
• DO NOT retract the red safety lock slider to the unlocked position until the covered stent is ready to be deployed. Once retracted, the safety lock slider cannot be repositioned to the locked position.
• DO NOT introduce or manipulate the delivery system without an appropriately sized guidewire and without fluoroscopic guidance. For brachial access, use an introducer sheath that covers the pathway from the access site to the aorta.
• For contralateral procedures, a long crossover introducer sheath or guiding catheter must be placed across the aortoiliac bifurcation.
• Careful attention by the operator is warranted to mitigate the potential for distal migration of the covered stent during deployment. Avoid tracking around a 90 degree angle.
• The delivery system will appear with small wrinkles in the stent sheath. In bench and animal testing, the presence of these wrinkles was not observed to adversely affect the performance or functionality of the delivery system.
• The device has not been tested for use in an overlapped condition with a bare metal stent or covered stents from other manufacturers. One or more components of the device contain the following substance defined as CMR 1B (reproduction toxic) in a concentration above 0.1% weight by weight: – N-Methyl-2-pyrrolidinone (NMP; CAS No. 872-50-4) N-Methyl-2-pyrrolidinone (NMP) is a solvent used in the manufacturing process of certain components of the Revello™ Vascular Covered Stent Delivery System. NMP has been shown to have adverse effects in experimental animals, including reproductive and developmental effects. BD has not assessed any related adverse effects in relation to the exposure to NMP when this device is used with neonates, infants, pregnant or breast-feeding women. It is the responsibility of the physician to assess risks associated with the use of a device containing NMP. – Cobalt (CAS No. 7440-48-4) Current scientific evidence supports that medical devices manufactured from cobalt alloys or stainless steel alloys containing cobalt do not cause an increased risk of cancer or adverse reproductive effects. Potential Complications and Adverse Events: Complications and Adverse Events associated with the use of the Revello™ Vascular Covered Stent may include the usual complications associated with endovascular stent and covered stent placement. These events can vary in severity and outcome, including death. Potential complications may include, but are not limited to the following: Allergic reaction; Amputation; Aneurysm; Covered stent stenosis/thrombotic occlusion; Edema; Elastic vessel recoil; Embolism; Hematoma; Hemorrhage; Infection; Pain; Pseudoaneurysm; Stenosis/thrombotic occlusion outside the stented segment; Surgical intervention; Vessel injury. Please consult product labels and instructions for use for indications, contraindications, hazards, warnings, and precautions.