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Pulsar-18 US Rev C 18.05.2017 11:49 Seite 1 IFU Pulsar-18 US rev C 18.05.2017 11:49 Seite 1 Pulsar-18 Peripheral self-expanding Nitinol stent system English Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. IFU Pulsar-18 US rev C 18.05.2017 11:49 Seite 2 Device Description Contraindications The Pulsar-18 stent system (Figure 1) is a self-expanding stent loaded on an • Patients with known hypersensitivity to nickel or amorphous silicon carbide. over-the-wire (OTW) delivery system. The stent (1) is laser-cut from a Nitinol • Patients with uncorrected bleeding disorders and contraindication to tube. It carries 6 radiopaque marker extensions at each end (1a, 1b) and is antiplatelet and/or anti-coagulation therapy. completely coated with amorphous silicon carbide (a-SiC:H). The delivery system consists of two coaxially arranged elements: the inner shaft () and the Warnings outer shaft (3). The central guide wire lumen within the inner shaft begins with a radiopaque tip • In patients with poor kidney function, contrast agents may precipitate kidney (7) at the distal wire exit and ends with a Luer port (6) at the proximal guide wire failure. exit. The stent is loaded between the inner shaft and the outer shaft proximal to • Persons with known hypersensitivities to the following substances may suffer the tip, between two radiopaque markers (8), which facilitate fluoroscopic an allergic reaction to this implant: visualization, and positioning of the stent system towards and across the lesion. - nitinol and / or its components (e.g. nickel, titanium) The outer shaft begins proximally within the handle (9) and extends towards the - amorphous silicon carbide distal tip, covering the stent. A hydrophobic coating is applied to the outside of • DO NOT use after the “use by” date specified on the label. the inner shaft and the inside and the outside of the entire outer shaft. The guide • Device is supplied STERILE and for single use only. DO NOT re-sterilize and/or wire lumen of the inner shaft and the annular space between the inner shaft reuse. Reuse of single use devices creates potential risks including infections. and the outer shaft are flushed simultaneously through the Luer port at the Contamination of the device may lead to serious injury or patient harm. proximal guide wire exit. The guide wire lumen permits the use of 0.018" (0.46 mm) guide wires to facilitate advancement of the stent system toward and • Appropriate anticoagulation and antiplatelet therapy should be administered through the lesion to be treated. pre- and post-procedure in accordance with standard practices. The outer shaft is covered proximally with a blue colored tube (13) that indicates • If using to treat a previously stented lesion, long-term outcomes following the progress and completion of stent deployment and a transparent tube (1) to repeat dilatation of endothelialized stents have not been studied. protect from kinking. • DO NOT use if the sterile package is opened or damaged or any information Prior to deployment, the locking tab (4) must be removed and discarded. The provided is obscured. DO NOT use if the device is damaged or if the stent is stent is deployed with the trigger (5). In case the trigger release mechanism partially deployed. fails, partial stent deployment can be completed as follows: first, open the • DO NOT use in patients after failed guide wire or balloon catheter access. handle using the secondary release ring (10) and button (14), then pull directly • DO NOT use guide wires with 0.014” (0.36 mm) diameter. on the blue tube. Pulsar-18 features an “Easy Release” (11) fitted over the • If unusual resistance is experienced during the introduction of the delivery proximal outer shaft. The “Easy Release” is intended to be inserted into the system or deployment, or if stent cannot be deployed, remove the entire stent hemostatic valve of the introducer to reduce friction between the stent system system (a partially deployed stent may require surgical removal). and the hemostatic valve during stent release. • Advancement of the stent system without the guide wire extended beyond the tip may lead to vessel damage. Figure 1: Pulsar-18 stent system • DO NOT advance a partially deployed stent proximally or distally. Dragging or repositioning the stent may cause injury to the patient. • Once the stent is partially deployed it cannot be recaptured using the stent system. • Limited data exists on use of two overlapping stents. If multiple stents are required to treat a lesion, it is only recommended to use stents of same metal type and a maximum of two stents. The risk of corrosion increases when stents of differing metals contact one another. Overlapping of more than two stents has not been investigated. Precautions • Only physicians thoroughly trained and educated in the performance of PTA and stent implantation should use this device. • Stenting across a bifurcation or side branch could compromise future diagnostic or therapeutic procedures. The stent system and the “Easy Release” are compatible with an appropriately • The minimum introducer sheath size is indicated on the label. If the device is sized introducer sheath according to the indications on the label. used in conjunction with long and/or braided introducer sheaths, a larger The stent is advanced to the intended implantation location by means of the French size than indicated on the label may be necessary to reduce friction. over-the-wire delivery system and is deployed by means of the handle and • Use only guide wires with a 0.018” (0.46 mm) diameter. trigger mechanism. The stent remains in the vessel as a permanent implant. • Verify that the distal end of the outer shaft is flush against the tip. If a gap exists between the outer shaft and the tip, do not use the device. How Supplied • Exercise care during handling to reduce the possibility of releasing the stent Sterile. Non-pyrogenic. Device is sterilized with ethylene oxide. prematurely, accidental breakage, bending or kinking of the catheter shaft. • Exposure of the stent system to organic solvents, e.g. alcohol, may cause Contents damage to the stent system. • The delivery system is not designed for use with power injection systems. • One (1) Pulsar-18 self-expanding stent system in a sealed, peel-open pouch. • Always keep the device filled with sterile heparinized isotonic saline while it • One (1) Patient Implant Card. is in the vascular system. • One (1) Instruction Card. • Avoid manipulation of the stent release mechanism during removal from packaging and flushing of the stent system. Storage • If more than one stent is planned to treat a lesion, it is recommended to place Store in a dark, dry location between 10°C (50°F) and 30°C (86°F). the more distal stent first. Allow for sufficient overlap between the stents. • Recrossing a stent with adjunct devices must be performed with caution. Indications • The use of mechanical atherectomy devices or laser catheter is not recommended within the stented area. The Pulsar-18 stent system is indicated for use to improve luminal diameter in patients with symptomatic de novo, restenotic or occlusive lesions located in the superficial femoral or proximal popliteal arteries, with reference vessel diameters from 3.0 to 6.0 mm and total lesion lengths up to 190 mm. IFU Pulsar-18 US rev C 18.05.2017 11:49 Seite 3 Potential Adverse Events/Complications Introduction and delivery of the stent system Possible complications include, but are not limited to: 07. Thread the distal tip of the stent system over the proximal end of the guide wire and advance the system until the wire exits the Luer port at the • Allergic reactions to contrast media, antiplatelet aggregation or anticoagulant proximal end of the delivery system. Take care to keep the delivery system medications, amorphous silicon carbide and nitinol and/or its components as straight as possible. (e.g. nickel, titanium) 08. Carefully insert the stent system through the introducer while immobilizing • Bleeding events: Access site bleeding or hemorrhage, hemorrhage requiring the guide wire. transfusion or other treatment 09. Carefully advance the stent system over the guide wire just distal to the • Death lesion to be treated. • Embolization of air, thrombotic or atherosclerotic material 10. Insert the "Easy Release" into the introducer (to reduce friction between the • Emergency surgery to correct vascular complications hemostatic valve and the outer shaft of the delivery system during stent • Infection and sepsis deployment). Blood loss may increase when the “Easy Release” is used. • Stent system events: Failure to deliver stent to intended site, stent 11 While pressing the trigger (5) with the thumb (figure A1) gently twist (45°) misplacement, stent deformation, stent embolization, stent thrombosis or and pull out the locking tab (4) (figure A and A3). occlusion, stent fracture, stent migration, inadequate apposition or 1. Lift thumb to release pressure off the trigger and allow it to extend out of the compression of stent/s, withdrawal difficulties, embolization of catheter handle (figure A4). material • Tissue necrosis and limb loss due to distal embolization • Vascular events: Access site hematoma, hypotension/ hypertension, pseudoaneurysm, arteriovenous fistula formation, retroperitoneal hematoma, vessel dissection or perforation, restenosis, thrombosis or 45° occlusion, vasospasm, peripheral ischemia, dissection, distal embolization (air, tissue debris, thrombus) Directions for use A1 A2 Patient preparation and stent system selection PTA and placement of a self-expanding nitinol stent should be performed in an angiography equipped room. Patients are to be prepared in accordance with hospital or local procedures. It is recommended to pre-dilate the lesion using standard PTA techniques before stenting. Maintain lesion access with the guide wire when removing the PTA balloon catheter from the patient. 01. Select the appropriate stent size based on the diameter of the artery A3 A4 adjacent to the lesion and the length of the segment to be stented.
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