Contraindications: Malign or benign strictures in the upper part of esophagus close to the cricopharyngeal muscle.

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1 Manufactured by: ELLA CS, s.r.o. Milady Horákové Hradec Králové 6 Czech Republic Phone: Fax: Instructions for Use FerX-ELLA Esophageal Stent (Boubella) Esophageal self-expandable metallic stent with the delivery system Non-active implantable device Product contents : 1 piece of Selfexpandable FerX-ELLA Esophageal Stent (Boubella) 1 piece of the Delivery System Sheath (delivery system) dimensions: Outer diameter [mm/f] Active length [mm] Sheath 6.0 (18 F) / 9.4 (28 F) piece of Instructions for Use 1 piece of Patient s Card 1 piece of unfixed package label (to be inserted into the patient s medical record) Precautions: Sterilized in ethylene oxide gas in peel-open packages. Use the undamaged and unopened package only. Single use product. Do not re-sterilize. The device must be used prior to the expiry date printed on the package. Indications: The FerX-ELLA Esophageal Stent (Boubella) is constructed for traversing malignant or benign esophageal strictures if standard operation is contraindicated. It can be used for treatment of esophagorespiratory fistulas as well. The stent is shaped in order to reduce migration rate to a minimum see figure No. 1. Contraindications: Malign or benign strictures in the upper part of esophagus close to the cricopharyngeal muscle. Relative contraindications: Use of the valved stent shall be carefully considered in patients after partial gastrectomy which produced small, horizontally lying gastric remnant. Distal end of migrated stent might impact into the gastric wall and consequently closed the valve. Possible complications: Stent migration, inadequate positioning of stent, obstruction by food, decubital esophago-respiratory fistula (mainly after radiotherapy), decubital esophago-aortic fistula, insufficient functional length of stent, tumor ingrowth, fissure of esophageal wall, allergic reaction, local pain within 2-3 days after implantation. Warnings: The physician implanting the stent shall be skilled appropriately. Stent shall be introduced by using the ultra stiff guide wire only. NMR examination is recommended when stent is firmly incorporated (approximately 8 weeks after implantation). Stent implantation shall be done under fluoroscopic and endoscopic control. If it is needed to correct stent misplacement / partial migration or to remove it from the stomach by dragging the retrieval loop, strictly follow this instruction! The patient shall eat semi-solid food and drink plenty of liquid. FerX OLI-3M-AJ-05/04/I/REV-14-12/2010 Page 1 of 7

2 It shall be taken into account that compression along the longitudinal axis can reduce nominal stent length by mm. The antimigration segment of the stent must be placed out of the tumorous stricture, i.e. in the healthy tissue adjacent to the upper part of tumor. (See figure No. 4) Warning: After releasing even a small part of the stent do not move the sheath forward. This may damage the foil between the segments. There would be a danger of cutting off the segment of the stent. Material composition of the stent: Stainless steel wire segments of the stent Polyester thread tying up the ends of the segments Special medical grade alloy retrieval loop tying up the stent throat and the last segment Au golden tubes (markers) placed on the stent strut at the transitional area between the antimigration segment and the flexible trunk of the stent Polyethylene the foil coverage of the stent and the anti-reflux valve. Storage: The device shall be stored in a dust-free, dry and dark place at room temperature. I. PREPARATION The patient must be prepared as for a standard gastroscopic examination. It is recommended to dilate the esophageal stricture to the minimum diameter of 10 mm. After removing the delivery system from the package, inspect it for any visible damage (i.e. holes, tears, openings, breakage or bends). NOTE: The small hole (about 2 mm) located on the sheath in the transition part 28 F to 18 F is the technological gap intended for stent loading into delivery system. This small hole does not have any influence on device function. II. STENT IMPLANTATION 1) Introduce safely under endoscopic control a min. 220 cm long Ultra Stiff guide wire with diameter 0.89 mm (0.035 inch) into the stomach. 2) Remember that the right length of the stent (6-7 cm longer than the lesion) shall be chosen. Information about the length of the stent model is presented on the label of the package. 3) Remove the delivery system out of the package. The delivery system contains the compressed stent. The olive forms a firm cone preventing damage to the esophageal wall during insertion of the stent. Place the delivery system on the guide wire and insert it into the esophagus. NOTE: Prior to releasing the stent from the delivery system, position the stent as follows: The distal end of the compressed stent inside the delivery system should extend at least 2 cm beyond the lower margin of the stenosis. 4) Remove the lock from the delivery system. NOTE: The lock shall be removed immediately before start of the stent deployment. At the moment of starting the deployment, the olive automatically splits into two pieces falling into the stomach. 5) Keeping the pusher in a stable position, pull back the sheath until the stent opens sufficiently. The stent opens gradually and reaches its full extension within 48 hours. NOTE: The proximal rim of the stent shall extend approximately 5-6 cm. beyond the edge of the stenosis. (See figure No. 4) 6) Remove the delivery system along the guide wire. It is necessary to remove the delivery system simultaneously with the guide wire in such a way the olive of the delivery system safely covered the distal end of the guide wire. 7) After successfully implanting the stent, perform the swallowing test. Administer appropriate volume of the contrast liquid and check the patency of the stent and anti-reflux valve. In case of the stent with anti-reflux valve this maneuver may open the closed anti-reflux valve. III. COMPLICATIONS AND THEIR MANAGEMENT 1) Misplacement or incomplete migration of stent. The problem can be solved by using an endoscope. The diameter of the stent throat can be reduced by grasping and pulling on the retrieval loop. This maneuver enables the manipulation of the stent. (See figure No. 2) FerX OLI-3M-AJ-05/04/I/REV-14-12/2010 Page 2 of 7

3 2) Complete the migration of stent from the stenotic area. Introduction of the new stent is required. The migrated stent could be removed surgically or endoscopically. The use of an endoscope is similar to that described above. The difference is that you have to pull on retrieval loop placed at the distal end of the stent, i.e. opposite the funnel-shaped throat. Injury of the esophagus wall shall be avoided. The mark shall be grasped firmly. Accidentally releasing the mark could lead to obstruction of the airways. See drawings. (See figure No. 3) 3) Obstruction of the stent by food. It takes place when the patient does not observe the diet discipline. Obstruction can be released by endoscope equipped with the suitable accessories. 4) Decubital esophagorespiratory fistula. Introducing the new stent into the old one (re-stenting) can close the fistula. Stents shall be overlapped by 4 cm. 5) Decubital esophago-aortic fistula. Emergency surgery must be performed. 6) Insufficient functional length of the stent. Re-stenting can solve this problem. 7) Tumor ingrowth or overgrowth Re-stenting or endoscopic ablation of the tissue can solve this problem. 8) Fissuration of the esophageal wall. A surgical intervention is required (mediastinal drainage, antibiotic therapy etc.). 9) An allergic reaction. Standard treatment using anti-allergenic drugs is required. 10) Persisting pain in location of stent implantation after the above mentioned complications were excluded Pain requires pharmacological management. In rare cases analgesic-anodyne drug shall be administered for a long time. Take into account that continuing pain could be caused by fissuration FerX OLI-3M-AJ-05/04/I/REV-14-12/2010 Page 3 of 7

4 Figure No. 1 Schema of the FerX-ELLA Esophageal Stent (Boubella) Level of flexibility of FerX-ELLA Esophageal Stent (Boubella) depends on number of centrally mounted segments FerX OLI-3M-AJ-05/04/I/REV-14-12/2010 Page 4 of 7

5 Table No. 1 lengths of stent L [mm] L A [mm] Number of centrally mounted segments * * * * * * * * * last segment Figure No. 2 Grasp of the stent throat during correction of malposition (partial migration) Figure No. 3 Grasping the distal end of the stent during withdrawal from the stomach (full migration) WARNING! A stent that is fully migrated to the stomach shall only be grasped by its distal end! FerX OLI-3M-AJ-05/04/I/REV-14-12/2010 Page 5 of 7

6 Figure No. 4 Proper stent placement FerX OLI-3M-AJ-05/04/I/REV-14-12/2010 Page 6 of 7

7 Figure No. 5 - Scheme of the delivery system Last revision date: December 2010 FerX OLI-3M-AJ-05/04/I/REV-14-12/2010 Page 7 of 7

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