INDICATIONS, SAFETY, AND WARNINGS Transcatheter Pulmonary Valve (TPV) Replacement

Melody™ Transcatheter Pulmonary Valve Ensemble™ II Transcatheter Valve Delivery System


IMPORTANT LABELING INFORMATION FOR UNITED STATES

INDICATIONS

The Melody TPV is indicated for use  in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (RVOT) conduit or surgical bioprosthetic pulmonary valve that has ≥ moderate regurgitation, and/or a mean RVOT gradient ≥35 mm Hg.

CONTRAINDICATIONS

None known.

WARNINGS/PRECAUTIONS/SIDE EFFECTS

  • DO NOT implant in the aortic or mitral position. Preclinical bench testing of the Melody valve suggests that valve function and durability will be extremely limited when used in these locations.
  • DO NOT use if patient’s anatomy precludes introduction of the valve, if the venous anatomy cannot accommodate a 22-Fr size introducer, or if there is significant obstruction of the central veins.
  • DO NOT use if there are clinical or biological signs of infection including active endocarditis. Standard medical and surgical care should be strongly considered in these circumstances.
  • Assessment of the coronary artery anatomy for the risk of coronary artery compression should be performed in all patients prior to deployment of the TPV.
  • To minimize the risk of conduit rupture, do not use a balloon with a diameter greater than 110% of the nominal diameter (original implant size) of the conduit for pre-dilation of the intended site of deployment, or for deployment of the TPV.
  • The potential for stent fracture should be considered in all patients who undergo TPV placement. Radiographic assessment of the stent with chest radiography or fluoroscopy should be included in the routine postoperative evaluation of patients who receive a TPV.
  • 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.

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, blistering, or peeling of skin, pain, swelling, or bruising at the catheterization site. 

Potential device-related adverse events that may occur following device implantation include the following: stent fracture*, 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.

*The term "stent fracture" refers to the fracturing of the Melody TPV. However, in subjects with multiple stents in the RVOT it is difficult to definitively attribute stent fractures to the Melody frame versus another stent.

For additional information, please refer to the Instructions For Use provided with the product or available on http://manuals.medtronic.com.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.


Important Labeling Information for Geographies Outside of the United States

Indications

The Melody™ TPV is indicated for use in patients with the following clinical conditions:

  • Patients with regurgitant prosthetic right ventricular outflow tract (RVOT) conduits or bioprostheses with a clinical indication for invasive or surgical intervention, OR
  • Patients with stenotic prosthetic RVOT conduits or bioprostheses where the risk of worsening regurgitation is a relative contraindication to balloon dilatation or stenting

Contraindications

  • Venous anatomy unable to accommodate a 22 Fr size introducer sheath
  • Implantation of the TPV in the left heart
  • RVOT unfavorable for good stent anchorage
  • Severe RVOT 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

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, swelling or bruising at the catheterization site.

Potential device-related adverse events that may occur following device implantation include the following: stent fracture*, 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.

*The term "stent fracture" refers to the fracturing of the Melody TPV. However, in subjects with multiple stents in the RVOT it is difficult to definitively attribute stent fractures to the Melody frame versus another stent.

For additional information, please refer to the Instructions For Use provided with the product or available on http://manuals.medtronic.com.

The Melody Transcatheter Pulmonary Valve and Ensemble II Transcatheter Delivery System has received CE Mark approval and is available for distribution in Europe.