Indications, Safety, and Warnings

CoreValve^® Evolut^® R Transcatheter Aortic Valve
Melody^® Transcatheter Pulmonary Valve

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CoreValve^® Evolut^® R Transcatheter Aortic Valve

Indications

The Medtronic CoreValve Evolut R system is indicated for use in patients with symptomatic heart disease due to either severe native calcific aortic stenosis or failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons predicted risk of operative mortality score ≥8% or at a ≥15% risk of mortality at 30 days).

Contraindications

The CoreValve Evolut R system is contraindicated for patients presenting with any of the following conditions: known hypersensitivity or contraindication to aspirin, heparin (HIT/HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel), or sensitivity to contrast media, which cannot be adequately premedicated; ongoing sepsis, including active endocarditis; preexisting mechanical heart valve in aortic position.

Warnings

General
Implantation of the Medtronic CoreValve Evolut R system should be performed only by physicians who have received Medtronic CoreValve Evolut R training.This procedure should only be performed where emergency aortic valve surgery can be performed promptly. Mechanical failure of the delivery catheter system and/or accessories may result in patient complications. Transcatheter Aortic Valve (Bioprosthesis) Accelerated deterioration of the bioprosthesis may occur in patients presenting with an altered calcium metabolism.

Precautions

General
The safety and effectiveness of the Medtronic CoreValve Evolut R system have not been evaluated in the pediatric population. The safety and effectiveness of the bioprosthesis for aortic valve replacement have not been evaluated in the following patient populations: with a native valve lesion which does not meet the criteria for severe aortic stenosis (aortic valve area ≤1.0 cm2 or aortic valve area index ≤0.6 cm2/m2, a mean aortic valve gradient of ≥40 mm Hg, or a peak aortic-jet velocity ≥4.0 m/s); who are at moderate or low surgical risk (predicted perioperative mortality risk of <15%); with untreated, clinically significant coronary artery disease requiring revascularization; with a preexisting prosthetic heart valve with a rigid support structure in either the mitral or pulmonic position if either the preexisting prosthetic heart valve could affect the implantation or function of the bioprosthesis or the implantation of the bioprosthesis could affect the function of the preexisting prosthetic heart valve; with cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support. The safety and effectiveness of a CoreValve Evolut R bioprosthesis implanted within a failed preexisting transcatheter prosthesis have not been demonstrated. Implanting a CoreValve Evolut R bioprosthesis in a degenerated surgical bioprosthesis [transcatheter aortic valve in surgical aortic valve (TAV in SAV)] should be avoided in the following conditions. The degenerated surgical bioprosthesis presents with a: significant concomitant perivalvular leak (between the prosthesis and the native annulus), is not securely fixed in the native annulus, or is not structurally intact (eg, wireform frame fracture); partially detached leaflet that in the aortic position may obstruct a coronary ostium; stent frame with a manufacturer's labeled inner diameter <17 mm. The safety and effectiveness of the bioprosthesis for aortic valve replacement have not been evaluated in patient populations presenting with the following: blood dyscrasias as defined: leukopenia (WBC <1000 cells/mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states; congenital bicuspid or unicuspid valve; mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation [3-4+]); moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation; hypertrophic obstructive cardiomyopathy; new or untreated echocardiographic evidence of intracardiac mass, thrombus, or vegetation; native aortic annulus size <18 mm or >26 mm per the baseline diagnostic imaging or surgical bioprosthetic aortic annulus size <17 mm or >26 mm; transarterial access not able to accommodate an 18-Fr sheath or the 14-Fr equivalent EnVeo R InLine sheath; sinus of valsalva anatomy that would prevent adequate coronary perfusion; moderate to severe mitral stenosis; severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%; end-stage renal disease requiring chronic dialysis or creatinine clearance <20 cc/min; symptomatic carotid or vertebral artery disease; severe basal septal hypertrophy with an outflow gradient.

Prior to Use
Exposure to glutaraldehyde may cause irritation of the skin, eyes, nose, and throat. Avoid prolonged or repeated exposure to the vapors. Damage may result from forceful handling of the catheter. Prevent kinking of the catheter when removing it from the packaging. This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/ or create a risk of contamination of the device, which could result in patient injury, illness, or death. The bioprosthesis size must be appropriate to fit the patient's anatomy. Proper sizing of the device is the responsibility of the physician. Refer to Instructions for Use for available sizes. Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. Patients must present with access vessel diameters of ≥5 mm or an ascending aortic (direct aortic) access site ≥60 mm from the basal plane. Implantation of the bioprosthesis should be avoided in patients with aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) of >30° for right subclavian/axillary access or >70° for femoral and left subclavian/axillary access. Use caution when using the subclavian/axillary approach in patients with a patent LIMA graft or patent RIMA graft. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft.

During Use
For direct aortic and subclavian access procedures, care must be exercised when using the tip-retrieval mechanism to ensure adequate clearance to avoid advancement of the catheter tip through the bioprosthesis leaflets during device closure. For direct aortic access procedures, use a separate introducer sheath; do not use the EnVeo R InLine sheath. Adequate rinsing of the bioprosthesis with sterile saline, as described in the Instructions for Use, is mandatory before implantation. During rinsing, do not touch the leaflets or squeeze the bioprosthesis. If a misload is detected, unsheath the bioprosthesis and examine the bioprosthesis for damage (for example, permanent frame deformation, frayed sutures, or valve damage). Do not attempt to reload a damaged bioprosthesis. Do not load the bioprosthesis onto the catheter more than 2 times or after it has been inserted into a patient. Use the deployment knob to deploy and recapture the bioprosthesis. Do not use the trigger for deploying or recapturing because it could cause inaccurate placement of the bioprosthesis. Once the radiopaque capsule marker band reaches the distal end of the radiopaque paddle attachment (point of no recapture), retrieval of the bioprosthesis from the patient is not recommended. Retrieval after the point of no recapture may cause mechanical failure of the delivery catheter system, aortic root damage, coronary artery damage, myocardial damage, vascular complications, prosthetic valve dysfunction (including device malposition), embolization, stroke, and/or emergent surgery. During deployment, the bioprosthesis can be advanced or withdrawn as long as annular contact has not been made. Once annular contact is made, the bioprosthesis cannot be advanced in the retrograde direction; recapture until the bioprosthesis is free from annular contact, and then reposition in the retrograde direction. If necessary, and the radiopaque capsule marker band has not yet reached the distal end of the radiopaque paddle attachment, the bioprosthesis can be withdrawn (repositioned) in the antegrade direction. However, use caution when moving the bioprosthesis in the antegrade direction. While the catheter is in the patient, ensure the guidewire is extending from the tip. Do not remove the guidewire from the catheter while the catheter is inserted in the patient. Use the handle of the delivery system to reposition the bioprosthesis. Do not use the outer catheter sheath. Once deployment is complete, repositioning of the bioprosthesis is not recommended. Repositioning of a deployed valve may cause aortic root damage, coronary artery damage, myocardial damage, vascular complications, prosthetic valve dysfunction (including device malposition), embolization, stroke, and/or emergent surgery. Do not attempt to retrieve or to recapture a bioprosthesis if any one of the outflow struts is protruding from the capsule. If any one of the outflow struts has deployed from the capsule, the bioprosthesis must be released from the catheter before the catheter can be withdrawn. Ensure the capsule is closed before catheter removal. When using a separate introducer sheath, if increased resistance is encountered when removing the catheter through the introducer sheath, do not force passage. Increased resistance may indicate a problem and forced passage may result in damage to the device and/or harm to the patient. If the cause of resistance cannot be determined or corrected, remove the catheter and introducer sheath as a single unit over the guidewire, and inspect the catheter and confirm that it is complete. Clinical long-term durability has not been established for the bioprosthesis. Evaluate bioprosthesis performance as needed during patient follow-up. Postprocedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. Postprocedure, administer anticoagulation and/or antiplatelet therapy per physician/clinical judgment. Excessive contrast media may cause renal failure. Preprocedure, measure the patient’s creatinine level. During the procedure, monitor contrast media usage. Conduct the procedure under fluoroscopy. The safety and efficacy of a CoreValve Evolut R bioprosthesis implanted within the initial transcatheter bioprosthesis have not been demonstrated. However, in the event that a CoreValve Evolut R bioprosthesis must be implanted within the initial transcatheter bioprosthesis to improve valve function, valve size and patient anatomy must be considered before implantation of the CoreValve Evolut R bioprosthesis to ensure patient safety (for example, to avoid coronary obstruction). In the event that valve function or sealing is impaired due to excessive calcification or incomplete expansion, a postimplant balloon dilatation of the bioprosthesis may improve valve function and sealing. To ensure patient safety, valve size and patient anatomy must be considered when selecting the size of the balloon used for dilatation. The balloon size chosen for dilatation should not exceed the diameter of the native aortic annulus or, for surgical bioprosthetic valves, the manufacturer’s labeled inner diameter. Refer to the specific balloon catheter manufacture’s labeling for proper instruction on the use of balloon catheter devices. Note: Bench testing has only been conducted to confirm compatibility with NuMED Z-MED IITM Balloon Aortic Valvuloplasty catheters where CoreValve Evolut R bioprosthesis device performance was maintained after dilation. Data on File.

Potential Adverse Events

Potential risks associated with the implantation of the Medtronic CoreValve Evolut R transcatheter aortic valve may include, but are not limited to, the following:

• death
• myocardial infarction, cardiac arrest, cardiogenic shock, cardiac tamponade
• coronary occlusion, obstruction, or vessel spasm (including acute coronary closure)
• cardiovascular injury (including rupture, perforation, tissue erosion, or dissection of vessels, ascending aorta trauma, ventricle, myocardium, or valvular structures that may require intervention)
• emergent surgical or transcatheter intervention (for example, coronary artery bypass, heart valve replacement, valve explant, percutaneous coronary intervention [PCI], balloon valvuloplasty)
• prosthetic valve dysfunction (regurgitation or stenosis) due to fracture; bending (out-of-round configuration) of the valve frame; underexpansion of the valve frame; calcification; pannus; leaflet wear, tear, prolapse, or retraction; poor valve coaptation; suture breaks or disruption; leaks; mal-sizing (prosthesis-patient mismatch); malposition (either too high or too low)/malplacement
• prosthetic valve migration/ embolization
• prosthetic valve endocarditis
• prosthetic valve thrombosis
• delivery catheter system malfunction resulting in the need for additional re-crossing of the aortic valve and prolonged procedural time
• delivery catheter system component migration/embolization
• stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), or other neurological deficits
• individual organ (for example, cardiac, respiratory, renal [including acute kidney failure]) or multi-organ insufficiency or failure
• major or minor bleeding that may require transfusion or intervention (including life-threatening or disabling bleeding)
• vascular access-related complications (for example, dissection, perforation, pain, bleeding, hematoma, pseudoaneurysm, irreversible nerve injury, compartment syndrome, arteriovenous fistula, stenosis)
• mitral valve regurgitation or injury
• conduction system disturbances (for example, atrioventricular node block, left-bundle branch block, asystole), which may require a permanent pacemaker
• infection (including septicemia)
• hypotension or hypertension
• hemolysis
• peripheral ischemia
• bowel ischemia
• abnormal lab values (including electrolyte imbalance)
• allergic reaction to antiplatelet agents, contrast medium, or anesthesia
• exposure to radiation through fluoroscopy and angiography
• permanent disability.

Please reference the CoreValve Evolut R Instructions for Use for more information regarding indications, warnings, precautions and potential adverse events.

Caution: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only. 

Melody^® Transcatheter Pulmonary Valve Ensemble^® Transcatheter Valve Delivery System

Important Labeling Information for United States

Indications

The Melody TPV is indicated for use as an adjunct to surgery in the management of pediatric and adult patients with the following clinical conditions:

• Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted AND
• Dysfunctional RVOT conduits with a clinical indication for intervention, AND:
  • regurgitation: ≥ moderate regurgitation, AND/OR
  • stenosis: 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.

Caution: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only.