English
On-X
®
Prosthetic Heart Valve | Instructions for Use
2
TABLE OF CONTENTS
ON-X
®
PROSTHETIC HEART VALVE ........................................................ 2
INSTRUCTION FOR USE ......................................................................... 4
1. DEVICE DESCRIPTION ...................................................................... 4
2. INDICATIONS FOR USE .................................................................... 4
3. CONTRAINDICATIONS ...................................................................... 4
4. WARNINGS AND PRECAUTIONS ...................................................... 5
4.1 WARNINGS ...................................................................................... 5
4.2 PRECAUTIONS ................................................................................ 5
5. POTENTIAL ADVERSE EVENTS ......................................................... 5
6. INDIVIDUALIZATION OF TREATMENT .............................................. 5
6.1 SPECIFIC PATIENT POPULATION .................................................... 5
7. PATIENT COUNSELING ...................................................................... 5
8. HOW SUPPLIED ................................................................................ 6
8.1 AVAILABLE MODELS AND SIZES .................................................... 6
8.2 PACKAGING .................................................................................... 6
8.3 STORAGE ........................................................................................ 6
8.4 ACCESSORIES ................................................................................. 7
8.5 ACCESSORY CLEANING AND STERILIZATION .............................. 8
9. DIRECTIONS FOR USE ....................................................................... 8
9.1 PHYSICIAN TRAINING ..................................................................... 8
9.2 STERILIZATION AND RESTERILIZATION ........................................ 8
9.3 HANDLING AND PREPARATION INSTRUCTIONS ........................ 8
9.4 DEVICE IMPLANTATION ...............................................................10
9.5 SUTURING TECHNIQUES ...............................................................10
9.6 LEAFLET MOTION ASSESSMENT AND VALVE ROTATION ...........11
9.7 VALVE ORIENTATION .....................................................................12
10. POSTOPERATIVE INFORMATION .................................................. 12
10.1 MAGNETIC RESONANCE IMAGING (MRI) COMPATIBILITY .......12
10.2 RETURNED GOODS .....................................................................12
11. PATIENT INFORMATION ................................................................ 12
11.1 PATIENT REGISTRATION ..............................................................12
11.2 PATIENT RECORD CARD ..............................................................13
11.3 PATIENT INFORMATION BOOKLET .............................................13
12. DISCLAIMER OF WARRANTIES ..................................................... 13
APPENDIX A ........................................................................................ 13
1. ADVERSE EVENTS ........................................................................... 13
1.1 OBSERVED ADVERSE EVENTS .......................................................13
2. CLINICAL STUDIES ......................................................................... 13
ON-X
®
PROSTHETIC
HEART VALVE
INSTRUCTIONS FOR USE
On-X
®
Aortic Heart Valve with
Standard Sewing Ring
On-X
®
Mitral Heart Valve with
Standard Sewing Ring
On-X
®
Aortic Heart Valve with
Conform-X
®
Sewing Ring
On-X
®
Mitral Heart Valve with
Conform-X
®
Sewing Ring
On-X
®
Aortic Heart Valve with
Anatomic Sewing Ring
On-X
®
Aortic Heart Valve and
Extended Holder
On-X
®
Aortic Heart Valve with
Conform-X
®
Sewing Ring and
Extended Holder
On-X
®
Aortic Heart Valve with
Anatomic Sewing Ring and
Extended Holder
For more information visit
www.onxlti.com/ifu
