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6.2.1. Identification
For patients found to have a substantial increase in the degree of RVOT obstruction, the possibility of an associated stent
fracture should be considered and evaluated. Radiographic assessment of the stent with chest radiography or fluoroscopy
should be included in the routine postprocedural evaluation of patients who receive a TPV.
6.2.2. Management
If a stent fracture is detected, continued monitoring of the stent should be performed in conjunction with clinically appropriate
hemodynamic assessment. In patients with stent fracture and significant associated RVOT obstruction or regurgitation,
reintervention should be considered in accordance with usual clinical practice.
Reintervention may include implantation of an additional Melody™ TPV or surgical conduit replacement. Note that limited data
are available in the Melody™ clinical studies on reimplantation of another Melody™ TPV within the original Melody™ TPV.
6.3. Endocarditis
Endocarditis is a potential adverse event associated with all bioprosthetic valves (Section 5). Patients should make their health
care providers aware that they have a bioprosthetic valve before any procedure.
A low incidence of suspected endocarditis has been reported in patients implanted with the Melody™ TPV. Unexplained,
prolonged fever may be an indication of infection, and patients with these conditions should be advised to seek medical
attention.
Prophylactic antibiotic therapy is recommended for patients implanted with a Melody™ TPV undergoing dental procedures.
6.4. Traceability labels
Product traceability labels are provided for hospital use only and are not to be returned to Medtronic.
6.5. Registration information
A patient registration form is included in TPV packages for countries that require patient registration.
Note: Patient registration does not apply in countries where patient privacy laws conflict with providing patient information,
including countries from the EU.
After implantation, please complete all requested information. The serial number is located on both the package and the
identification tag attached to the TPV. Return the original form to the Medtronic address indicated on the form and provide the
temporary identification card to the patient prior to discharge.
Medtronic will provide an Implanted Device Identification Card to the patient. The card contains the name and telephone
number of the patient's physician as well as information that medical personnel would require in the event of an emergency.
Patients should be encouraged to carry this card with them at all times.
6.6. MRI safety information
Nonclinical testing and modeling has demonstrated that the Melody™ TPV is MR Conditional. A patient with this device can be
safely scanned in an MR system meeting the following conditions:
■
Static magnetic field of 1.5 T and 3.0 T
■
Maximum spatial gradient magnetic field of 2500 gauss/cm (25 T/m)
■
Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of scanning
(Normal Operating Mode)
Based on nonclinical testing and modeling, under the scan conditions defined above, the Melody™ TPV is expected to produce
a maximum in vivo temperature rise of less than 2.1°C after 15 minutes of continuous scanning.
MR image quality may be compromised if the area of interest is in the same area, or relatively close to the position of the
device. In nonclinical testing, the image artifact caused by the device extends approximately 3 mm from the Melody™ TPV
when imaged with a spin echo pulse sequence and 6 mm when imaged with a gradient echo pulse sequence and a 3.0 T MRI
System. The lumen of the device was obscured.
For deployment of a Melody™ TPV inside a bioprosthesis or stent, consult the MRI labeling pertaining to the bioprosthesis or
stent for additional image artifact information. It may be necessary to optimize MR imaging parameters for the presence of this
implant.
Scanning under the conditions defined above may be performed immediately after implantation.
The presence of other implants or medical circumstances of the patient may require lower limits on some or all of the above
parameters.
10
Instructions for Use
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