Indications For Use; Warnings And Precautions; Patient Counseling Information; Potential Adverse Events - Medtronic Open Pivot Instrucciones De Uso

Separate sewing cuffs are available for mitral or aortic implantation (Figure 1, Figure 2, and Figure 3). Cuff
markers are provided to assist in the uniform placement of sutures around the valve annulus.
■
aortic cuff – 3 markers at 120° intervals
■
mitral cuff – 4 markers at 90° intervals

2. Indications for Use

The Medtronic Open Pivot Heart Valve is intended for use as a replacement valve in patients with diseased,
damaged, or malfunctioning heart valves. This device may also be used to replace a previously implanted
prosthetic heart valve.
3. Contraindications
The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation
therapy.

4. Warnings and Precautions

4.1. Warnings
■
This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product.
Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or
create a risk of contamination of the device, which could result in patient injury, illness, or death.
■
Use only Medtronic Open Pivot Heart Valve holders, rotators, and sizers.
■
Leaflet motion must be tested only with the blue leaflet actuator enclosed in each valve package. Do not
test leaflet motion or touch the valve with metal instruments.
■
Never pass any catheter or instrument through the valve.
■
Do not handle the valve except with the accessories provided. Contact with the valve by any other
instruments may cause damage to the leaflets and orifice or result in imperfections on blood contact
areas. Scratching the surface may lead to a loss of structural integrity.
■
When securing the valve in place, suture needles should be passed through the outer half of the sewing
cuff and suture ends should be cut short after the knots are tied.
■
It is suggested that only taper point needles be used for suturing the cuff as taper cut or other cutting
needles may cut the cuff fibers.
■
Force should never be applied to the valve leaflets.
■ Before closing the heart, test for leaflet motion with the blue leaflet actuator. If necessary, rotate the valve
to avoid abnormal residual pathology which could interfere with leaflet motion.
■
Persons allergic to cobalt, chromium, or nickel may suffer an allergic reaction to this device.
4.2. Precautions
■
The outer carton label serves as a tamper-evident package seal. After removing the double barrier trays
from the shipping package, examine them carefully to verify that the seals and trays are intact. If any
seal is damaged or missing, do not use the valve.
■
If the Use By date has expired, the device should not be used.

4.3. Patient Counseling Information

■
Patients with prosthetic valves who undergo dental or potentially bacteremic procedures should receive
antibiotic prophylaxis.
■
All mechanical prosthetic heart valves produce sound as a function of their operation. Patients should
be advised of this prior to implantation.
■
Patients should be encouraged to carry the Implanted Device Identification Card, provided by Medtronic,
with them at all times.

5. Potential Adverse Events

Adverse events potentially associated with the use of prosthetic aortic heart valves include, but are not limited
to:
■
angina
■
cardiac arrhythmia
■
endocarditis
■
hemolysis
■
hemolytic anemia
■
hemorrhage, anticoagulation-related
■
myocardial infarction
■
leaflet entrapment (impingement)
■
nonstructural dysfunction
■
pannus
■
perivalvular leak
■
transvalvular regurgitation
■
structural dysfunction
■
thrombosis
■
stroke
■
thromboembolism
It is possible that these complications could lead to:
■
reoperation
■
explantation
14 Instructions for Use English