Ovation 5X00419G01 Module

Ovation 5X00419G01 Module Westinghouse New In Stock

Introduction

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/orlead to device failure that may result in patient injury, illness or death. Reuse, reprocessing or re-sterilizationmay also create a risk of contamination of the device and/or cause patient infection, including, but not limitedto, the transmission of infectious disease(s) from one patient to another. Contamination of the device maylead 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 hypotensionto 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 limbcomplications that have required additional therapy. The risk of polymer leak should be carefully consideredalong with the risks associated with alternative treatment options when making personalized treatmentdecisions for those individuals who fall within the indicated patient population as defined by the Indicationsfor Use.

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

Ovation Products

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