Denali Vena Cava Instructions For Use Manual

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Jugular/Subclavian Vein Approach

Instructions For Use

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Page 1 ® Jugular/Subclavian Vein Approach Instructions for Use...
Page 3 10mm for the gradient echo sequence. Imaging parameters may need to be adjusted for artifact optimization. It is recommended that patients with a vena cava filter register the MR conditions with the MedicAlert Foundation (www. medicalert.org). C. Indications for Use The D ENALI ®...
Page 4 12. Never advance the guidewire or introducer sheath/dilator or deploy the filter without fluoroscopic guidance. 13. Filter fractures are a known complication of vena cava filters. There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques.
Page 5 Possible complications include, but are not limited to, the following: • Movement, migration or tilt of the filter are known complications of vena cava filters. Migration of filters to the heart or lungs has been reported. There have also been reports of caudal migration of the filter. Migration may be caused by placement in IVCs with diameters exceeding the appropriate labeled dimensions specified in this IFU.
Page 6 6. Nick the skin with a #11 blade and perform venipuncture with an 18 gauge entry needle. 7. Insert the 0.035” straight guidewire and gently advance it into the inferior vena cava. PRECAUTION: If resistance is encountered during the insertion procedure, withdraw the guidewire and check vein patency fluoroscopically with a small injection of contrast medium.
Page 7 21. Prior to deployment, verify the location of the filter within the sheath using fluoroscopy and confirm that the filter snare hook is 1cm below the lowest renal or is in the intended location in the inferior vena cava. 22. Deliver and release filter as described in Step 22. A-C: A.
Page 8 Filter if significant amounts of thrombus are trapped within the filter or if the filter snare hook is embedded within the vena cava wall. PRECAUTION: Care should be taken when advancing a guidewire or imaging catheter through a filter to prevent entanglement.
Page 11 Lot Number Working Sheath Length Catalogue Number Introducer Sheath Attention, See Instructions Bard and Denali are trademarks for Use and/or registered trademarks of C. R. Bard, Inc. or an affiliate. Sterilized Using Ethylene Oxide Copyright © 2016 C. R. Bard, Inc.
Page 12 Manufacturer: Bard Peripheral Vascular, Inc. 1625 West 3rd Street Tempe, AZ 85281 TEL: 1-480-894-9515 1-800-321-4254 FAX: 1-480-966-7062 1-800-440-5376 www.bardpv.com PK5380500 Rev. 6 03/16...