Indications For Use; Contraindications; Warnings And Precautions; Patient Counseling Information - Medtronic Open Pivot Gebrauchsanweisung

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aortic cuff – 3 markers at 120° intervals
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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
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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.
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Use only Medtronic Open Pivot heart valve holders, rotators, and sizers.
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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.
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Never pass any catheter or instrument through the valve.
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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.
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When a valve is released from a holder and implanted without using the holder, implant it with
attention to the valve orientation.
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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.
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Use only taper point needles for suturing the cuff as taper cut or other cutting needles may cut the cuff
fibers.
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Force should never be applied to the valve leaflets.
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Before closing the heart, test for leaflet motion with the blue leaflet actuator. If necessary, rotate the
valve to avoid abnormal residual pathology that could interfere with leaflet motion.
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Persons allergic to cobalt, chromium, or nickel may suffer an allergic reaction to this device.
4.2. Precautions
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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.
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If the Use-By Date has expired, the device should not be used.

4.3. Patient counseling information

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Patients with prosthetic valves who undergo dental or potentially bacteremic procedures should
receive antibiotic prophylaxis.
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All mechanical prosthetic heart valves produce sound as a function of their operation. Patients should
be advised of this prior to implantation.
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Encourage patients 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:
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Angina
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Cardiac arrhythmia
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Endocarditis
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Hemolysis
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Hemolytic anemia
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Hemorrhage, anticoagulation-related
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Myocardial infarction
■ Leaflet entrapment (impingement)
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Nonstructural dysfunction
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Pannus
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Perivalvular leak
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Transvalvular regurgitation
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Structural dysfunction
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Thrombosis
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Stroke
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Thromboembolism
It is possible that these complications could lead to:
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Reoperation
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Explantation
18 Instructions for Use English