Medtronic

Health Care Professionals | International
Locations Inside the U.S.
Info for Patients

Melody

Transcatheter pulmonary valve therapy

Brief Statement for:
Melody® Transcatheter Pulmonary Valve
Ensemble® Transcatheter Delivery System

Indications
The Melody® Transcatheter Pulmonary Valve is indicated for use in patients with the following clinical conditions:

  • Patients with regurgitant prosthetic Right Ventricular Outflow Tract (RVOT) conduits with a clinical indication for invasive or surgical intervention, OR
  • Patients with stenotic prosthetic RVOT conduits where the risk of worsening regurgitation is a relative contraindication to balloon dilatation or stenting.
  • Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted.
  • The intended lifetime for the Melody® device is 2 years.

Contraindications

  • Venous anatomy unable to accommodate a 22 Fr size introducer sheath; Implantation in left heart;
  • Unfavorable right ventricular outflow tract for good stent anchorage;
  • Severe right ventricular outflow obstruction, which cannot be dilated by balloon;
  • Obstruction of the central veins;
  • Clinical or biological signs of infection;
  • Active endocarditis;
  • Known allergy to aspirin or heparin;
  • Pregnancy.

Warnings

FOR SINGLE USE ONLY.
DO NOT RESTERILIZE THE VALVE BY ANY METHOD.
Exposure of the device and container to irradiation, steam, ethylene oxide, or other chemical sterilants will render the device unfit for use.
DO NOT use the device if:

  • The device has been dropped, damaged, or mishandled in any way.
  • The 'Use By' date has elapsed.
  • The tamper evident seal is broken.
  • The serial number tag does not match the container label.
  • It has been exposed to freezing or prolonged heat. (Check freeze indicator. If exposed to a freeze-thaw condition, the indicator vial will break, causing the dye to escape and stain the paper backing.)

The storage solution does not completely cover the device.DO NOT expose the device to solutions other than the storage and rinsing solutions.
DO NOT add antibiotics to either the storage or the rinse solution. Do not apply antibiotics to the device.
DO NOT allow the device to dry. Maintain tissue moisture with irrigation or immersion.
DO NOT attempt to repair a damaged device.
DO NOT handle or use forceps to manipulate the valve leaflet tissue.
DO NOT use forceps to manipulate the stent as this can damage the surface of the stent leading to stent fracture.
DO NOT overexpand the device beyond the recommended size utilizing a 22 mm balloon catheter as this can result in stent fracture.

Potential Complications / Adverse Events
Potential procedural complications that may result from implantation of the Melody device include the following: rupture of the RVOT conduit, compression of a coronary artery, perforation of a major blood vessel, embolization or migration of the device, perforation of a heart chamber, arrhythmias, allergic reaction to contrast media, cerebrovascular events (TIA, CVA), infection/sepsis, fever, hematoma, radiation-induced erythema, pain at the catheterization site.

Potential device-related adverse events that may occur following device implantation include the following: stent fracture resulting in recurrent obstruction, endocarditis, embolization or migration of the device, valvular dysfunction (stenosis or regurgitation), paravalvular leak, valvular thrombosis, pulmonary thromboembolism, hemolysis.

For additional information, please refer to the Instructions For Use provided with the product.

Melody and Ensemble are registered trademarks of Medtronic, Inc.

The Melody® Transcatheter Pulmonary Valve and Ensemble® Transcatheter Delivery system has received CE Mark approval and is available for distribution in Europe. Additionally, a Medical Device Licence has been granted and the system is available for distribution in Canada.