Medtronic
 
 

Melody Transcatheter Pulmonary Valve and Ensemble Transcatheter Delivery System

 

Melody® Transcatheter Pulmonary Valve and
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

Stented Valve
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.

Caution: Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure or breathing of the chemical vapor. Use only with adequate ventilation. If skin contact occurs, immediately flush the affected area with water (minimum of 15 minutes). In the event of eye contact, flush with water for a minimum of 15 minutes and seek medical attention immediately.

Delivery System
FOR SINGLE USE ONLY.
DO NOT reuse or resterilize the delivery system.
DO NOT dilate the balloon markedly beyond the diameter of the artery lying just proximal to the stenosis.
DO NOT use air or any gaseous substance as a balloon inflation medium.
DO NOT advance the guidewire, balloon dilatation catheter, or any other component if resistance is met, without first determining the cause and taking remedial action.
DO NOT remove the guidewire from the catheter at any time during the procedure.

POTENTIAL COMPLICATIONS / ADVERSE EVENTS
The Melody® Transcatheter Pulmonary Valve is a new device. Most of the reference literature addressing tissue or mechanical valved conduits describes hybrid devices composed of woven polyester tubing material and either a mechanical or biological valve sewn onto the lumen of the tube. The Melody® Transcatheter Pulmonary Valve is a totally integral native valved conduit sewn into a stent. Some of the complications reported with currently commercially available conduits may not be entirely applicable.
Prosthetic heart valves have been associated with serious complications, sometimes leading to reoperation and/or death. This may also be the case with the Melody® Transcatheter Pulmonary Valve. In addition, complications caused by immunogenic response to the device, or to physical, chemical, or biological changes, may occur at undetermined intervals, and may require reoperation and replacement of the device.
General complications reported with valved conduits and biological tissue valves implanted in the heart include the following:

  • Hemorrhage
  • Bleeding diathesis due to anticoagulant use
  • Residual or increasing transvalvular gradients
  • Progressive neointimal thickening and peeling
  • Progressive stenosis and obstruction of the implant
  • Progressive pulmonary hypertension
  • Graft infection, endocarditis
  • Regurgitation through an incompetent valve
  • Hemolysis
  • Valve malfunction
  • Implant deterioration, physical or chemical
  • Pulmonary embolism
  • Thrombus

Types of tissue deterioration include:

  • Calcification, intrinsic and extrinsic
  • Infection
  • Thickening
  • Perforation
  • Myxomatous degeneration
  • Valve leaflet deterioration

Cardiac catheterization carries certain risks. Potential complications and related adverse events include but are not limited to the following:

  • Device embolization or migration
  • Laceration or rupture of blood vessels
  • Device misorientation or misplacement
  • Bleeding
  • Stent fracture
  • Loss of structural integrity due to stent fracture
  • Hematoma
  • Endocarditis
  • Arrhythmias
  • Thrombosis
  • Pain at the catheterization site
  • Distal thromboembolism
  • Cerebrovascular incident
  • Valve dysfunction
  • Allergic reaction to contrast agents
  • Paravalvular leak
  • Perforation of cardiac chambers
  • Pseudoaneurysm
  • Rupture of the prosthetic RVOT conduit
  • Sepsis/infection
  • Heart failure
  • Fever
  • Compression of the coronary arteries
  • Death

These complications may present clinically with abnormal heart murmur, shortness of breath, exercise intolerance, dyspnea, orthopnea, anemia, fever, arrhythmia, hemorrhage, low cardiac output, pulmonary edema, congestive heart failure, and death.

The Melody® Transcatheter Pulmonary Valve and Ensemble® Transcatheter Delivery System have received CE Mark approval and are available for distribution in Europe. Additionally, a Medical Device Licence has been granted and the system is available for distribution in Canada. Products are not available for sale in the United States.

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