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Table of Contents
Summary of Contents for Ovation TriVascular
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Page 1: Instructions For Use
Instructions for Use (810-0005-01-05) 0 0 5 0 0 0 5 0 810-0005-01-05 Rev B... -
Page 2: Table Of Contents
6.2. Specific Patient Populations ........9 Patient Counseling Information ........9 How Supplied ..............10 8.1. Ovation Stent Graft & Delivery Systems ....11 8.2. Fill Polymer Kit & Autoinjector ......... 11 Clinician Use Information ..........12 9.1. Physician Training ..........12 9.2. -
Page 3: Device Description
Device Description The TriVascular Ovation™ Abdominal Stent Graft System is an endovascular device delivered via a low-profile catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an alternate endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing or eliminating the risk of rupture. -
Page 4: Fill Polymer
If an iliac extension is required, the delivery system is advanced over the guidewire and deployed using the method described above for contralateral and ipsilateral iliac limbs. Figure 2. Schematic of TriVascular Ovation Abdominal Stent Graft System aortic body delivery catheter Figure 3. Schematic of TriVascular Ovation Abdominal Stent Graft System iliac... -
Page 5: Ancillary Components
1.3. Ancillary Components Figure 5. TriVascular Autoinjector Indications for Use The TriVascular Ovation Abdominal Stent Graft System is indicated in subjects diagnosed with an aneurysm in the abdominal aorta having vascular morphology suitable for endovascular repair, including: Adequate iliac/femoral access compatible with vascular access techniques, •... -
Page 6: Warnings And Precautions
• intervention procedures in the event that conversion to open surgical repair is necessary. The TriVascular Ovation Abdominal Stent Graft System should only be used • by physicians and teams experienced in endovascular techniques, and who have been trained in its use. This experience should include:... -
Page 7: Adverse Events
• based on hospital and physician preferred protocol. If heparin is contraindicated, an alternative anticoagulant should be considered. Do not bend or kink the Ovation Abdominal Stent Graft System because it • may damage the device and/or its components. Always use fluoroscopic guidance to advance the delivery system and to •... -
Page 8: Incident Reporting
5.2. Incident Reporting All incidents should be reported to TriVascular immediately. To report an event, contact your local representative and/or the Authorized Representative at the contact number provided at the end of this document. -
Page 9: Patient Selection And Treatment
Patient Selection and Treatment 6.1. Individualization of Treatment The TriVascular Ovation Abdominal Stent Graft System must be selected in a size appropriate to the patient’s anatomy. The sizing options for the device are detailed in Table 1 Patient Sizing Information. -
Page 10: How Supplied
• enlargement, or rupture). How Supplied The Ovation Abdominal Stent Graft System is comprised of the aortic body stent graft/ delivery system, the iliac limbs and extensions stent graft/ delivery system, the fill polymer kit, and the autoinjector. The stent grafts are available in the following sizes and configurations. -
Page 11: Ovation Stent Graft & Delivery Systems
16 mm 18 mm 14 F 22 mm 8.1. Ovation Stent Graft & Delivery Systems Contents are supplied STERILE and non-pyrogenic using an ethylene oxide (EO) process. Inspect the device and packaging to verify that no damage has occurred as •... -
Page 12: Clinician Use Information
CAUTION: The Ovation Abdominal Stent Graft System should only be used by physicians and teams trained in vascular interventional techniques and in the use of this device. - Page 13 Stent Graft Iliac Limbs (2) preloaded in Delivery Systems TriVascular Ovation Abdominal Stent Graft Iliac Extensions preloaded in Delivery Systems TriVascular Fill Polymer Kit Timer or clock TriVascular Autoinjector Imaging Equipment with Video recorder capability to record and recall all...
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Page 14: Mri Information
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the Ovation Abdominal Stent Graft System. Therefore, optimization of MR imaging parameters to compensate for the presence... -
Page 15: Directions For Use
Appropriate procedural imaging is required to successfully position the • TriVascular Ovation Abdominal Stent Graft System in the vasculature and to assure appropriate arterial wall apposition. Always use fluoroscopy for guidance, delivery, and observation of the TriVascular Ovation Abdominal Stent Graft System within the vasculature. - Page 16 Using sterile technique, place delivery system onto sterile field. Inspect delivery system for damage; if present, replace device. For the aortic body only, carefully retract delivery system outer sheath approximately 1 cm to facilitate retraction within the vasculature. Advance catheter sheath to its original position. If sheath retraction is difficult, replace device.
- Page 17 Fill Polymer Preparation Using sterile technique, place fill polymer kit and autoinjector onto sterile field. Open both fill kit syringe valves, and transfer contents between syringes for a minimum of 20 full strokes. Completely transfer contents into syringe with green band (fill syringe) and close both stopcocks. Remove tear tab and disconnect fill syringe.
- Page 18 allergies (e.g., antihistamines, corticosteroids, adrenaline). Contralateral Limb Insertion and Deployment Cannulate the contralateral lumen with a guidewire. CAUTION: Confirm cannulation of graft true lumen to ensure accurate placement of the contralateral limb. Use imaging techniques to locate the contralateral internal iliac artery. Confirm appropriate size (diameter and length) of iliac limb selected for contralateral side, and prepare iliac limb delivery system (per above instructions).
- Page 19 polymer fill port should move away from stent graft. WARNING: If resistance is encountered during catheter withdrawal, STOP. Identify cause of resistance and resolve prior to continuing withdrawal. Catheter rotation may be sufficient to overcome resistance. While maintaining guidewire position, use catheter handle to retract nosecone to tip of delivery system outer sheath.
- Page 20 Iliac Extension Insertion and Deployment Using the radiopaque markers on the distal end of the iliac limb as a target and using standard endovascular techniques, cannulate the iliac limb lumen with a guidewire (if necessary). Determine the amount of extension required. If 20 mm or less, use of a straight distal extension is recommended.
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Page 21: Follow-Up Imaging Recommendations
Re-insert angiographic catheter and advance to the suprarenal aorta. Perform deployment completion angiography as described above. 11. Follow-up Imaging Recommendations TriVascular recommends the following imaging schedule for patients treated with the Ovation Abdominal Stent Graft System. Table 6. Recommended patient imaging schedule... - Page 22 Patient motion should be avoided during scan. If possible, avoid scanning non- patient objects in field of view. Do not change patient position, table height, or field of view during scan. If patient moves, repeat the study in its entirety. Table 7.
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Page 23: Symbols
12. Symbols Batch Code Use by Contents Non-pyrogenic PYROGEN PYROGEN Consult Instructions for use MR Conditional Upper limit of temperature for excursions during transit only Do not reuse Do not resterilize STERILIZE STERILIZE STERILIZE Keep dry Do not use if package is damaged Sterilized using ethylene oxide STERILE R STERILE R... - Page 24 Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 (+1) 707.543.8800 Authorized Representative: MediTech Strategic Consultants B.V. Maastrichterlaan 127-129 6291 EN Vaals, NL T: +31.43.306.3320 F: +31.43.306.3338 © 2012 TriVascular, Inc. All rights reserved. June 2012...
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