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1、INSTRUCTIONS FOR USE FOR en English dk Dansk nl Nederlands fi Suomi fr Fran ais de Deutsch gr it Italiano no Norsk pt Portugu s es Espa ol se Svensk TABLE OF CONTENTS DESCRIPTION 1 INTENDED USE INDICATIONS FOR USE 2 CONTRAINDICATIONS 2 WARNINGS 2 PRECAUTIONS 3 MRI SAFETY AND COMPATIBILITY 3 ADVERSE
2、EVENTS 4 DEVICE RELATED ADVERSE EVENT REPORTING 6 SUMMARY OF US CLINICAL STUDIES 6 PRIMARY DE NOVO STUDY 6 TIPS REVISION COHORT 11 HOW SUPPLIED 13 STORAGE AND HANDLING 13 REQUIRED MATERIALS 13 DIRECTIONS FOR USE 13 POST PLACEMENT MANAGEMENT OF THE TIPS 15 DEFINITIONS 16 1 INSTRUCTIONS FOR USE GORE V
3、IATORR TIPS ENDOPROSTHESIS NOTICE FOR USE WITHIN THE UNITED STATES Caution Federal law USA restricts this device to sale by or on the order of a physician Carefully read all instructions prior to use Observe all warnings and precautions noted throughout these instructions Fplications DESCRIPTION The
4、 GORE VIATORR Transjugular Intrahepatic Portosystemic Shunt TIPS Eprised of an implantable endoprosthesis and percutaneous delivery catheter Endoprosthesis refer to Figure 1 The endoprosthesis consists of an electropolished self expanding nitinol nickel titanium stent that supports a reduced permeab
5、ility expanded polytetrafluoroethylene ePTFE graft The endoprosthesis is divided into two functional regions a graft lined intrahepatic region and an unlined portal region The interface between the lined and unlined regions is indicated by a circumferential radiopaque gold marker band An additional
6、radiopaque gold marker is located on the trailing edge of the device Endoprosthesis diameters and lengths are provided in Table 1 Figure 1 GORE VIATORR TIPS Endoprosthesis Radiopaque Gold Marker Unlined Portal Region ePTFE Graft Lined Intrahepatic Region Circumferential Radiopaque Gold Marker Band E
7、lectropolished Nitinol Stent Percutaneous Delivery Catheter refer to Figure 2 The endoprosthesis is secured to the leading end of a dual lumen delivery catheter beneath a containment plastic access sleeve The access sleeve constrains the unlined chain link portion of the endoprosthesis and facilitat
8、es insertion of the delivery catheter through the hemostatic valve of an introducer sheath and should not be removed prior to use A mark on the access sleeve serves as a guide to confirm correct insertion depth for large valve assemblies Tpatible with a 0 038 0 97 mm diameter guidewire and has a wor
9、king length of 75 cm A radiopaque marker is located beneath the leading tip of the delivery catheter A removable ePTFE constraining sleeve is used to constrain and subsequently deploy the graft lined region of the GORE VIATORR TIPS Endoprosthesis An extension of the constraining sleeve becomes the d
10、eployment line which is routed through the catheter shaft and allows for deployment of the device The trailing end of the delivery catheter is attached to a hub assembly that includes a central hemostatic guidewire port a flushing port and a port for the deployment line deployment knob The delivery
11、catheter is packaged with a removable stainless steel shipping mandrel inserted into the leading edge of the guidewire lumen that must be removed prior to flushing or use Figure 2 Dual Lumen Delivery Catheter Access Sleeve Radiopaque Marker Deployment Knob Flushing Port Hemostatic Guidewire Port Rem
12、ovable Mandrel Deployment Line Hub Assembly Constrained Endoprosthesis Insertion Guide Mark 2 Table 1 GORE VIATORR TIPS Endoprosthesis Dimensions and Recommended Accessories Endoprosthesis Dimensions Internal Diameter mm Graft Lined Length Unlined Length1 cm cm Maximum Dilatation Balloon Diameter4 m
13、m Hemostatic Introducer Sheath3 Fr Maximum Guidewire Diameter2 inches Recommended Accessory Equipment Labeled4 2 8810 0 038 10X1010 0 038 12X1210 0 038 5 2 X 6 2 X X 7 2 X 8 2 X XXXXX X 1 Lengths may vary by 0 5 cm 2 A stiff guidewire having a length of at least 180 cm and a maximum diameter 0 038 0
14、 97 mm is required Delivery catheter working length is 75 cm for all endoprosthesis configurations 3 Introducer sheath length must be sufficient to be delivered into the portal circulation by 3 cm It is recommended that a wall reinforced 10 Fr TIPS introducer sheath with an integral radiopaque marke
15、r band a hemostatic valve large enough to accept the 13 Fr access sleeve and a length of approximately 40 45 cm be used e g COOK FLEXOR CHECK FLO II 4 The same balloon dilatation device can be used for TIPS dilatation and dilatation of the endoprosthesis following implantation INTENDED USE INDICATIO
16、NS FOR USE The GORE VIATORR TIPS Endoprosthesis is indicated for use in the de novo and revision treatment of plications such as variceal bleeding gastropathy refractory ascites and or hepatic hydrothorax CONTRAINDICATIONS There are no known contraindications for this device WARNINGS The risks and potential adverse effects of creating a TIPS in patients with pre existing conditions such as those listed below must be considered relative to the potential benefits of this procedure 1 Patients with
