Tabla De Contenido - COOK Medical Zenith TX2 Instrucciones De Uso

Table of Contents
1 Device Description
1.1 Zenith
1.2 Thoracic Z-Trak
2 Intended Use
3 Contraindications
4 Warnings and Precautions
4.1 General
4.2 Patient Selection, Treatment and Follow-Up
4.3 Implant Procedure
4.4 Molding Balloon Use - Optional
4.5 MRI Safety and Compatibility
5 Potential Adverse Events
6 Potential Risks and Benefits
7 Patient Selection and Treatment
7.1 Individualization of Treatment
8 Patient Counseling Information
9 How Supplied
10 Clinical Use Information
10.1 Physician Training
10.2 Inspection Prior to Use
10.3 Materials Required
10.4 Device Diameter Sizing Guidelines
11 Directions for Use
11.1 The Zenith
1.1 Placement of Straight Component / Tapered Component
12 Imaging Guidelines and Post-Operative Follow-Up
12.1 General
12.2 Contrast and Non-Contrast CT Recommendations
12.3 Chest Radiographs
12.4 MRI Safety and Compatibility
12.5 Additional Surveillance and Treatment
13 References
I-ZDEG-EU-1105-394-02
® TX2 ® Dissection Endovascular Graft with Pro-Form
Z-Trak ® Plus Introduction System
® Plus Introduction Systems
® TX2 ® Dissection Endovascular Graft with Pro-Form
and Z-Trak Plus Introduction System
®
11.1.2 Component Molding Balloon Insertion
® and
®
ENGLISH 3