Ovation TriVascular Instructions For Use Manual Download Page 24

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Manufacturer:

TriVascular, Inc.

3910 Brickway Blvd.

Santa Rosa, CA 95403

USA

(+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

June 2012

Summary of Contents for TriVascular

Page 1: ...810 0005 01 05 Rev B Instructions for Use 810 0005 01 05 EN 0 05 0 0 05 0...

Page 2: ...ent Selection and Treatment 9 6 1 Individualization of Treatment 9 6 2 Specific Patient Populations 9 7 Patient Counseling Information 9 8 How Supplied 10 8 1 Ovation Stent Graft Delivery Systems 11 8...

Page 3: ...of the graft and to provide support into which the iliac limbs are deployed the graft body contains a network of inflatable rings that are filled with a liquid polymer that solidifies during the depl...

Page 4: ...tion Abdominal Stent Graft System is designed to accommodate various aortic anatomies including a range of proximal and distal aortic neck diameters and aneurysm lengths Refer to Table 1 for patient s...

Page 5: ...ices and or accessories Non aneurysmal proximal aortic neck with a length of at least 7 mm proximal to the aneurysm with an inner wall diameter of no less than 16 mm and no greater than 30 mm and with...

Page 6: ...d All patients treated with this device must undergo periodic imaging to evaluate the stent graft aneurysm size aneurysm pulsatility device migration leaks device integrity and occlusion of vessels in...

Page 7: ...Events Adverse events that may occur include but are not limited to Acute and chronic renal failure renal microembolism renal insufficiency renal artery occlusion contrast toxicity Allergic reaction...

Page 8: ...sible infection urinary tract systemic or localized endograft Pneumothorax Pulmonary respiratory events and subsequent attendant problems such as pulmonary insufficiency pneumonia respiratory depressi...

Page 9: ...ions for patient selection include but are not limited to Patient s age and life expectancy Co morbidities e g cardiac pulmonary or renal insufficiency prior to surgery morbid obesity Patient morpholo...

Page 10: ...delivery system the fill polymer kit and the autoinjector The stent grafts are available in the following sizes and configurations Table 2 Ovation Aortic Body Stent Graft sizes Stent Graft Proximal Di...

Page 11: ...place For single patient use only Do not reuse reprocess or re sterilize Reuse reprocessing or re sterilization may compromise the structural integrity of the device and or lead to device failure tha...

Page 12: ...nal techniques and in the use of this device The recommended skill knowledge requirements for physicians using the Ovation Abdominal Stent Graft System are outlined below Patient Selection Knowledge o...

Page 13: ...uoroscopy capability Digital Subtraction Angiography DSA capability Appropriate personnel protection equipment for fluoroscopy Video recorder Power injector with associated supplies Angiography and ex...

Page 14: ...ated Heating In non clinical testing the Ovation Abdominal Stent Graft System produced the following temperature rises during MRI performed for 15 min of scanning i e per pulse sequence in 1 5 Tesla 6...

Page 15: ...within the vasculature 10 2 Implant Procedure Do not kink the delivery catheters Doing so may cause damage to the delivery catheters and the TriVascular Ovation Abdominal Stent Graft System Systemic a...

Page 16: ...ker is toward patient s ipsilateral side CAUTION Rotate entire delivery system as a unit Do not independently rotate catheter sheath or handle 6 Under fluoroscopic guidance retract delivery system out...

Page 17: ...ill polymer kit Fill Polymer Injection WARNING DO NOT push or pull the delivery system after complete deployment of the proximal stent to avoid inadvertent disconnection of the polymer fill connector...

Page 18: ...ng of the aortic body most proximal ring 7 Confirm distal iliac limb radiopaque markers are at the appropriate location and that the iliac limb is in the contralateral lumen 8 Retract sheath to deploy...

Page 19: ...labeling Prepare balloon catheters and other adjunctive devices to be used according to the manufacturer s Instructions For Use Iliac limb aortic body junction The junction may be ballooned using a 12...

Page 20: ...b Distal Diameter 1 0 X X X 1 2 X X X 1 4 X X X 1 6 X X X 1 8 X X 2 2 X 20 mm Maximum allowable extension 3 To use an iliac limb as an extension refer to the table below Based on the iliac limb distal...

Page 21: ...paration and use of balloons 13 Re insert angiographic catheter and advance to the suprarenal aorta Perform deployment completion angiography as described above 11 Follow up Imaging Recommendations Tr...

Page 22: ...n 2 cm above celiac artery origin Inferior Extent AAA Pre op Lesser trochanter of femurs to include femoral bifurcations Post op At least 2 cm distal to the lowest hypogastric artery origin Pre op Les...

Page 23: ...mperature for excursions during transit only Do not reuse Do not resterilize Keep dry Do not use if package is damaged Sterilized using ethylene oxide STERILE R STERILE R Sterilized using irradiation...

Page 24: ...ckway Blvd Santa Rosa CA 95403 USA 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 TriVascu...

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