Ovation 5X00031G07 Module New In Box

Brand New Ovation 5X00031G07 Module One year warranty

Description

The Ovation iX Abdominal Stent Graft System is for single patient use only. Do not reuse, reprocess or resterilize. 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.  Polymer leaks are a unique potential risk of the Ovation device platform that have been reported postmarket. The complications of polymer leakage into the vasculature have ranged from transient hypotension to severe life-threatening anaphylactoid reactions, tissue necrosis and death. When polymer leaks occur, underfilling of the Ovation iX sealing rings have led to intraoperative Type Ia endoleaks and iliac limb complications that have required additional therapy. The risk of polymer leak should be carefully considered along with the risks associated with alternative treatment options when making personalized treatment decisions for those individuals who fall within the indicated patient population as defined by the Indications for Use (Section 2).  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 iX Abdominal Stent Graft System 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. 

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FAQ:

1.Is the part new? 
   Yes, 100% Original brand new
2.How is the package?
   Original factory seal packed
3.What is the lead time?
   In stock: 1-3 working days
4.What is the MOQ: 
   1pcs
5.What is the payment term:
   TT and Western Union, other negotiable
6.Where the item ship from?
   Xiamen
7.What is the warranty time?
   One year

8. How to delivery the PLC Parts?
   Kindly tell us your address,we check best cost for you
   Or you can use your own courier account or agent, DHL, FEDEX, UPS etc are available.

About Us

High Five PLC Parts Limited for many years, is a professional engaged in large-scale system (distributed control system, programmable controller, redundant fault-tolerant control systems, robot control system, large servo control system is the central feeding system plastic molding auxiliary equipment and automation of whole plant planning) imported automation system such as spare parts, modules, sales and system integration of high-tech enterprises. The company is equipped with professional technicians to provide customers with better service.

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