Ovation PLC DCS Spare Parts1C31142G01Westinghouse

Introduction

• The Ovation Prime Abdominal Stent Graft System and the Ovation iX Iliac Stent Graft are 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 that may result in patient injury, illness or death. Reuse, reprocessing or re-sterilization may also create a risk of contamination of the device and/or cause patient infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

• Accurate fluoroscopic imaging is required during any endovascular procedure and for proper device deployment. Implantation of this device should occur in an operating room, endovascular suite, catheterization laboratory, or similar sterile environment, with appropriately trained personnel, and suitable equipment and imaging capabilities.

• Do not use this device if the patient is unable to be evaluated using the necessary preoperative and postoperative imaging.

• Always have a qualified surgery team available during implantation or re-intervention procedures in the event that conversion to open surgical repair is necessary.

• The TriVascular Ovation Abdominal Stent Graft System and the Ovation iX Iliac Stent Graft should only be used by physicians and teams experienced in endovascular techniques and who have been trained in its use.

• The long-term performance of this implant has not been established. All patients treated with this device must undergo periodic imaging to evaluate stent graft integrity and position, aneurysm size, and potential endoleaks and/or, occlusion of vessels in the treatment area. Significant aneurysm enlargement, a persistent endoleak, the appearance of a new endoleak, device migration, reduced blood flow through the graft, and/or decrease in renal function due to renal artery occlusion should prompt further investigation into the need for further patient treatment, including additional intervention or surgical conversion. Additional patient imaging follow up should be considered for patients with devices that have effectiveness issues.

• All patients should be carefully counseled on the need for long-term follow up. The device is not recommended in patients unable or unwilling to comply with the information in Follow-up Imaging Recommendations.

Ovation Specifications

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