Table of Contents
1.
Device Description ............................................................ 3
1.1. Delivery System ........................................................ 3
1.2. Fill Polymer ............................................................... 4
1.3. Ancillary Components ............................................... 5
2.
Indications for Use .......................................................... 5
3.
Contraindications ............................................................ 5
4.
Warnings and Precautions ............................................. 6
4.1. General..................................................................... 6
4.2. Patient and Device Selection .................................... 6
4.3. Implant procedure ..................................................... 6
5.
Adverse Events ............................................................... 7
5.1. Potential Adverse Events .......................................... 7
5.2. Incident Reporting ..................................................... 8
6.
Patient 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
8.2. Fill Polymer Kit & Autoinjector ................................. 11
9.
Clinician Use Information ............................................. 12
9.1. Physician Training .................................................. 12
9.2. Inspection Prior to Use ............................................ 12
9.3. Materials Required .................................................. 12
9.4. MRI Information ...................................................... 14
10.
Directions for Use ......................................................... 15
10.1. Patient Preparation ................................................. 15
10.2. Implant Procedure .................................................. 15
10.3. Deployment Instructions .......................................... 15
11.
Follow-up Imaging Recommendations......................... 21
12.
Symbols ......................................................................... 23
