Important Safety Information
The Medtronic CoreValve system is indicated for use in patients with symptomatic heart disease due to 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 operative risk score ≥8% or at a ≥15% risk of mortality at 30 days).
The CoreValve 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
- Implantation of the Medtronic CoreValve system should be performed only by physicians who have received Medtronic CoreValve 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.
- The safety and effectiveness of the Medtronic CoreValve 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 bioprosthesis implanted within a failed preexisting transcatheter or surgical bioprosthesis have not been demonstrated.
- Implanting a CoreValve 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 verified by echocardiography
- 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 >29 mm per the baseline diagnostic imaging or surgical bioprosthetic aortic annulus size <17 mm or >29 mm
- transarterial access not able to accommodate an 18-Fr 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% as measured by resting echocardiogram
- 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 ≥6 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.
- 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 capsule becomes damaged during loading or the capsule fails to close, replace the entire system (bioprosthesis, catheter, and CLS). Do not use a catheter with a damaged capsule.
- After a bioprosthesis has been inserted into a patient, do not attempt to reload that bioprosthesis on the same or any other catheter.
- During implantation, if resistance to deployment is encountered (e.g., the micro knob starts clicking or is tight or stuck), apply upward pressure to the macro slider while turning the micro knob. If the bioprosthesis still does not deploy, remove it from the patient and use another system.
- 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.
- Once deployment is initiated, retrieval of the bioprosthesis from the patient (e.g., use of the catheter) is not recommended. Retrieval of a partially deployed valve using the catheter 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; if necessary, and the frame has only been deployed ≤2/3 of its length, the bioprosthesis can be withdrawn (repositioned) in the antegrade direction. However, use caution when moving the bioprosthesis in the antegrade direction.
- 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 (e.g., use of a snare and/or forceps) 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 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. 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 hospital protocol.
- 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 implanting a second CoreValve bioprosthesis within the initial CoreValve bioprosthesis have not been demonstrated. However, in the event that a second CoreValve bioprosthesis must be implanted within the initial CoreValve bioprosthesis to improve valve function, valve size and patient anatomy must be considered before implantation of the second CoreValve bioprosthesis to ensure patient safety (e.g., 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 II™ Balloon Aortic Valvuloplasty catheters where CoreValve™ bioprosthesis device performance was maintained after dilation. Data on File.
POTENTIAL ADVERSE EVENTS
Potential risks associated with the implantation of the Medtronic CoreValve transcatheter aortic valve may include, but are not limited to, the following:
- cardiac arrest
- coronary occlusion, obstruction, or vessel spasm (including acute coronary closure)
- emergent surgery (e.g., coronary artery bypass, heart valve replacement, valve explant)
- multi-organ failure
- heart failure
- myocardial infarction
- cardiogenic shock
- respiratory insufficiency or respiratory failure
- cardiovascular injury (including rupture, perforation, or dissection of vessels, ventricle, myocardium, or valvular structures that may require intervention)
- ascending aorta trauma
- cardiac tamponade
- cardiac failure or low cardiac output
- prosthetic valve dysfunction including, but not limited to, fracture; bending (out-of-round configuration) of the valve frame; under-expansion 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; regurgitation; stenosis
- thrombosis/embolus (including valve thrombosis)
- valve migration/valve embolization
- ancillary device embolization
- emergent percutaneous coronary intervention (PCI)
- emergent balloon valvuloplasty
- major or minor bleeding that may or may not require transfusion or intervention (including life-threatening or disabling bleeding)
- allergic reaction to antiplatelet agents, contrast medium, or anesthesia
- infection (including septicemia and endocarditis)
- stroke, TIA, or other neurological deficits
- permanent disability
- renal insufficiency or renal failure (including acute kidney injury)
- mitral valve regurgitation or injury
- tissue erosion
- vascular access related complications (e.g., dissection, perforation, pain, bleeding, hematoma, pseudoaneurysm, irreversible nerve injury, compartment syndrome, arteriovenous fistula, stenosis)
- conduction system disturbances (e.g., atrioventricular node block, left-bundle branch block, asystole), which may require a permanent pacemaker.
Please reference the CoreValve Instructions for Use for more information regarding indications, warnings, precautions and potential adverse events.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
CoreValve is a registered trademark of Medtronic CV Luxembourg S.a.r.l.
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