Medtronic Open Pivot Instrucciones De Uso página 18

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Suture techniques may vary according to the preference of the implanting surgeon and the anatomy of
the patient. The medical literature reports several preferred suturing methods.
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Sutures should be placed in the outer half of the cuff, particularly on the AP models. Deep needle
placement will contact the strengthening band inside the cuff and impede smooth placement of sutures.
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After sutures are placed in the valve cuff and the valve is seated in the tissue annulus, release the valve
from the valve holder. Slide a scalpel down the holder slot to cut the green suture and release the valve
holder. The green suture and valve holder will remain attached as the handle/rotator is carefully
withdrawn. The suture knots can be tied at this point. Long suture ends must be avoided.
Caution: Testing of leaflet motion must only be done with the enclosed blue leaflet actuator. Use of another
instrument may damage the valve. If the leaflets do not move freely due to contact with tissue, the valve
orifice may be rotated to a more optimal position. Rotate the orifice only after the suture knots have been
tied, securing the cuff to the tissue annulus.
Rotatability
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The valve orifice and leaflets may be rotated in situ by using the handle/rotator supplied in the package.
Freedom of rotation should be checked before implanting the valve by holding the valve cuff and gently
turning the valve handle/holder. Each valve size and model has a specific rotator. If desired, carefully
remove the rotator from the handle by turning the rotator counterclockwise. The rotator seats properly
into the valve orifice when the radial ridge on the handle side of the rotator head is aligned with the
straight edge of the leaflets. The rotator head is designed to contact the flat surfaces of the orifice near
the pivot areas. The orifice may be rotated in a clockwise or counterclockwise direction. After orientation
of the valve orifice in the patient's annulus, leaflet mobility may be determined with the blue leaflet
actuator.
Caution: Use only the rotator supplied with the device. Do not use any other instrument to rotate the valve.
Use of instruments other than those provided may cause damage to the orifice and leaflets and may result
in valve malfunction.
Caution: Extreme care must be exercised when handling the valve holder assembly to avoid structural
damage to the valve. Inspect each accessory before each use. Cracked or damaged accessories must not
be used.
7. Postoperative Information
7.1. Anticoagulation
The medical literature indicates that patients implanted with mechanical heart valves should be routinely
maintained on anticoagulants to reduce the risk of valve thrombosis and thromboembolism.
7.2. Diagnostic Imaging
The Medtronic Open Pivot Heart Valve provides excellent x-ray images due to the radiopaque strengthening
band around the orifice and 20% tungsten in each leaflet substrate.
7.3. Magnetic Resonance Imaging (MRI) Testing
The Medtronic Open Pivot Heart Valve (Models 500, 501, 503, and 505) was determined to be MR-
conditional according to the terminology specified in the American Society for Testing and Materials (ASTM)
International, Designation: F2503-05. Standard Practice for Marking Medical Devices and Other Items for
Safety in the Magnetic Resonance Environment. ASTM International, 100 Barr Harbor Drive, PO Box C700,
West Conshohocken, Pennsylvania, 2005.
Nonclinical testing demonstrated that the Medtronic Open Pivot Heart Valve (Models 500, 501, 503, and
505) is MR Conditional. A patient with this device can be scanned safely immediately after placement under
the following conditions:
7.4. Static Magnetic Field
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Static magnetic field of 3 Tesla or less
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Maximum spatial gradient magnetic field of 720 Gauss/cm or less
7.5. MRI-Related Heating
In nonclinical testing, the Medtronic Open Pivot Heart Valve (Models 500, 501, 503, and 505) produced the
following temperature rise during MRI performed for 15 minutes in the 3 T (3 T/128-MHz, Excite, HDx,
Software 14X.M5, General Electric Healthcare, Milwaukee, WI) MR system: Highest temperature change:
+1.6°C.
Therefore, the MRI-related heating experiments for the Medtronic Open Pivot Heart Valve (Models 500, 501,
503, and 505) at 3 T using a transmit/receive RF body coil at an MR system reported whole body averaged
SAR of 2.9 W/kg (ie, associated with a calorimetry measured whole body averaged value of 2.7 W/kg)
indicated that the greatest amount of heating that occurred in association with these specific conditions was
equal to or less than +1.6°C.
7.6. Artifact Information
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to
the position of the Medtronic Open Pivot Heart Valve.
Models 500, 501, and 503:
Pulse Sequence
Signal Void Size
Plane Orientation
16 Instructions for Use
T1-SE T1-SE
1,213 mm 2 486 mm
Parallel Perpendicular
English
GRE
2 2,189 mm
Parallel
GRE
2 1,369 mm 2
Perpendicular