SJM REGENTTM MECHANICAL HEART VALVE
INDICATION FOR USE
The SJM RegentTM Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic valve. This device may also be used to replace a previously implanted aortic prosthetic heart valve.
The SJM RegentTM Mechanical Heart Valve is contraindicated for individuals unable to tolerate anticoagulation therapy.
- For single use only. Attempts to reuse the valve may result in valve malfunction, inadequate sterilization, or patient harm.
- Do not use if:
- The valve has been dropped, damaged, or mishandled in any way.
- The expiration date has elapsed.
- The tamper-evident container seal or inner/outer tray seals are damaged, broken or missing.
- Remove any residual tissue that may impair valve size selection, correct seating of the valve, rotation of the valve, or leaflet motion.
- Proper valve size selection is crucial. Do not oversize the valve. If the native annulus measurement falls between two SJM RegentTM Mechanical Heart Valve sizes, use the smaller size SJM RegentTM Mechanical Heart Valve.
- Use only St. Jude MedicalTM mechanical heart valve sizers.
- The outer tray is not sterile, and should not be placed in the sterile field.
- To minimize direct handling of the valve during implantation, do not remove the holder/rotator until the valve has been seated in the annulus.
- Do not use hard or rigid instruments to test leaflet mobility, as this may result in structural damage to the valve or thromboembolic complications. Use a St. Jude MedicalTM leaflet tester to gently test valve leaflet mobility.
- Do not use cutting edge needles in the sewing cuff. If use of these needles is necessary, placement of sutures in the outer half of the sewing cuff is imperative.
- Never apply force to the valve leaflets. Force may cause structural damage to the valve.
- Use only the valve holder/rotator packaged with the SJM RegentTM Mechanical Heart Valve to perform valve rotation. Use of other instruments could result in structural damage. The valve holder/ rotator is intended for single use only and should be discarded after surgery.
- The two retention sutures on the valve holder/ rotator must be cut and removed before the SJM RegentTM Mechanical Heart Valve can be rotated.
- Do not pass catheters or other instruments through St. Jude MedicalTM mechanical heart valves. This could result in scratched or damaged valve components, or leaflet fracture or dislodgment.
- Cut suture ends short, especially in the vicinity of the pivot guards, to prevent leaflet impingement.
- Do not touch the prosthetic valve unnecessarily, even with gloved hands. This may cause scratches or surface imperfections that may lead to thrombus formation.
- Be careful not to cut or tear the valve sewing cuff when removing the identification tag and the holder/rotator from the SJM RegentTM Mechanical Heart Valve.
- Before placing sutures in the valve cuff, verify that the valve is mounted correctly on the valve holder/rotator.
- To avoid structural damage, the valve must be rotated in the fully closed position.
- To minimize rotational torque, verify that the valve holder/rotator is properly seated in the valve, and that the valve holder handle is perpendicular to the valve (Figures 15a and 15b).
- Remove any loose suture or thread, which may be a source of thrombus or thromboembolism.
POTENTIAL ADVERSE EVENTS
Complications associated with replacement mechanical heart valves include, but are not limited to:
hemolysis; infections; thrombus; or thromboembolism; valve dehiscence; unacceptable hemodynamic performance; hemorrhagic complications secondary to anticoagulation therapy; prosthetic failure; and heart failure or death.
Any of these complications may require reoperation or explantation of the device.