Indications, Safety, and Warnings

3f® Aortic Bioprosthesis

Indications: The 3f^® Aortic Bioprosthesis, Model 1000, is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.

Contraindications: The 3f^® Aortic Bioprosthesis, Model 1000, should not be used in those patients who present with congenital bicuspid anatomy or other forms of abnormal aortic root geometry.

Warnings/Precautions/Side Effects: Accelerated deterioration of the Model 1000 valve due to calcific degeneration may occur in children, adolescents, or young adults, or in patients with altered calcium metabolism such as patients on maintenance hemodialysis for chronic renal failure, patients with hyperparathyroidism, patients on high calcium diets, or patients requiring chronic calcium-containing drug therapy. The performance of the Model 1000 valve is, as is the case for all stentless bioprosthetic valves, dependent on accurate matching of the valve to the recipient patient’s aortic annular and sinotubular dimensions and may be adversely affected by high aortic root compliance. General complications potentially associated with the use of bioprosthetic heart valves include: leak (transvalvular, perivalvular), cardiac dysrhythmias, endocarditis, hemolysis, hemorrhage, non-structural dysfunction [NSD] (entrapment by pannus or suture, inappropriate sizing or positioning, or other), structural deterioration (intrinsic and extrinsic calcification, leaflet perforation or tear, leaflet thickening, or myxomatous degeneration), prosthesis stenosis, prosthesis regurgitation, valve thrombosis, thromboembolism.

CAUTION: Federal law restricts this device to sale by or on the order of a physician. This device is restricted to use by a physician who has participated in specific implantation training for the 3f^® Aortic Bioprosthesis, Model 1000.

CG Future Annuloplasty System

Indications: This device is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.

Contraindications: Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.

Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve repair should use this device. Adverse events can include: thromboembolic events, dehiscence, hemolysis, stenosis, residual incompetence, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage.

For additional information please refer to the Instructions for Use provided with the product or contact your local Medtronic representative. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Contegra Pulmonary Valved Conduit – HDE

Indications: See *Humanitarian Use Device section below.

Contraindications: None known.

Warnings/Precautions/Side Effects: Acceptable clinical performance has been established for the Contegra conduit in pediatric patients under the age of 10. Because of the possibility that complications of the device could become apparent only after extended use, a benefit – risk consideration of the long-term use of the Contegra conduit in pediatric patients over 10 years of age is particularly important. General complications reported with valved conduits and biological tissue valves implanted in the heart include: hemorrhage, bleeding diathesis due to use of anticoagulants, residual or increasing transvalvular gradients, progressive neointimal thickening and peeling, progressive stenosis and obstruction, progressive pulmonary hypertension, graft infection, endocarditis, regurgitation, hemolysis, valve malfunction, physical or chemical deterioration, thromboembolism, thrombus, conduit dilatation.

For additional information, please refer to the Instructions For Use provided with the product. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

*Humanitarian Use Device:
Authorized by Federal law for use in patients under 18 years of age for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT) in the following congenital heart malformations: Pulmonary Stenosis, Tetralogy of Fallot, Truncus Arteriosus, Transposition with Ventricular Septal Defect (VSD), Pulmonary Atresia. In addition, the Contegra Pulmonary Valved Conduit is indicated for the replacement of previously implanted but dysfunctional pulmonary homografts or valved conduits. The effectiveness of this device for these uses has not been demonstrated.

Duran AnCore Annuloplasty System

Indications: This device is indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves. Appropriate repair and annular remodeling may correct combined valvular insufficiency and stenosis. Note: The Chordal Guide feature of the Duran AnCore Ring/Band with Chordal Guide is indicated only for chordal replacement surgery of pathological mitral valves.

Contraindications: Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.

Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve repair should use this device. Adverse events can include: thromboembolic events, dehiscence, hemolysis, stenosis, residual incompetence, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage.

For additional information pelase refer to the Instructions for Use provided with the product or contact your local Medtronic representative. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
 

Freestyle Aortic Root Bioprostheses

Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement.

Contraindications: None known.

Warnings/Precautions/Adverse Events: Accelerated deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young adults, and patients with altered calcium metabolism (e.g., chronic renal failure, hyperparathyroidism). Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma.

For additional information, please refer to the Instructions For Use provided with the product. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

Hancock II and Hancock II Ultra Bioprostheses

Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves.

Contraindications: None known.

Warnings/Precautions/Adverse Events: Accelerated deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young adults, and patients with altered calcium metabolism (e.g., chronic renal failure, hyperparathyroidism). Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis.

For additional information, please refer to the Instructions For Use provided with the product. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

Hancock Porcine Valved Conduits

Indications: For use in reconstructive procedures for the repair of congenital or acquired cardiac and great vessel malformations or pathology.

Contraindications: Patients undergoing chronic hemodialysis have an increased tendency towards calcification of tissue valved conduits.

Warnings/Precautions/Adverse Events: Preclot valved conduits to minimize hemorrhage through the conduit. Reported complications include: valvular thrombosis, thromboembolism, calcification and fibrosis, valvular insufficiency, perivalvular insufficiency, valvular stenosis, leaflet perforation, significant transvalvular pressure gradients in small size bioprostheses, valve contamination, development of intraluminal peel, and hemorrhage through the graft and anastomotic sites.

For additional information, please refer to the Instructions For Use provided with the product. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Hancock Apical Left Ventricle Connectors

Indications: (Used in conjunction with Hancock Low Porosity Valved Conduits) Provide an alternate method for relief of left ventricular hypertension in patients with severe left ventricular outflow tract obstruction such as hypoplasia of the aortic root, aortic annulus, or acquired problems secondary to aortic valve replacement which cannot be relieved through conventional techniques.

Warnings/Precautions/Adverse Events: The potential for interstitial blood loss exists, particularly in patients with hemodilution or clotting factor deficiencies. Minimize serious bleeding complications by preclotting the connector and/or valved conduit. It is recommended that patients with significant left ventricular hypertrophy be studied by echocardiography. Thromboembolism, while infrequent, has been reported.

For additional information, please refer to the Instructions For Use provided with the product. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Medtronic Open Pivot Aortic Valved Graft

Indications: The Medtronic Open Pivot™ Aortic Valved Graft is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves, where a replacement valve and replacement or repair of the aorta is required.

Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. The Hemashield® Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. The graft should not be implanted in patients with a known sensitivity to products of bovine origin.

Possible Adverse Events: Adverse events potentially associated with the use of prosthetic heart valves include: angina, cardiac arrhythmia, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, myocardial infarction, leaflet entrapment (impingement), nonstructural dysfunction, pannus, perivalvular leak, regurgitation, structural dysfunction, thrombus, stroke, thromboembolism.

Adverse events potentially associated with the use of vascular grafts include: aneurysm; clinical reaction to collagen (shown to be a weak immunogen) described as infrequent, mild, localized, and self limiting; embolism; hemorrhage; infection; occlusion (including thrombosis and anastomotic intimal hyperplasia); pseudoaneurysm; seroma.

It is possible that these complications could lead to: reoperation, explantation, permanent disability, or death.

CAUTION: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions

Medtronic Open Pivot Mechanical Heart Valves

Indications: The Medtronic Open Pivot™ Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves.

Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy.

Possible Adverse Events: Adverse events potentially associated with the use of prosthetic heart valves include: cardiac arrhythmias, death, leaflet entrapment (impingement), endocarditis, hemolysis, anticoagulant-related hemorrhage, transvalvular or perivalvular leak, prosthesis thrombosis, structural deterioration, valve thromboembolism.

CAUTION: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions.

Mosaic Porcine Bioprostheses

Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves.

Contraindications: None known.

Warnings/Precautions/Adverse Events: Accelerated deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young adults, and patients with altered calcium metabolism (e.g., chronic renal failure, hyperparathyroidism). Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis.

For additional information, please refer to the Instructions For Use provided with the product. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

Profile 3D Annuloplasty System

Indications: This device is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.

Contraindications: Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.

Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve repair should use this device. Adverse events can include: thromboembolic events, dehiscence, hemolysis, stenosis, residual incompetence, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage.

For additional information please refer to the Instructions for Use provided with the product or contact your local Medtronic representative. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Simplici-T Annuloplasty System

Indications: This device is indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves. Appropriate repair and annular remodeling may correct combined valvular insufficiency and stenosis.

Contraindications: Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.

Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve repair should use this device. Adverse events can include: thromboembolic events, band dehiscence, hemolysis, stenosis, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage, uncorrected or recurrent regurgitation, low cardiac output, thrombosis, damage to coronary arteries.

For additional information please refer to the Instructions for Use provided with the product or contact your local Medtronic representative. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Simulus Annuloplasty Systems

Indications: This device is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.

Contraindications: Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.

Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve repair should use this device. Adverse events can include: thromboembolic events, dehiscence, hemolysis, stenosis, residual incompetence, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage. For additional information please refer to the Instructions for Use provided with the product or contact your local Medtronic representative.

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

Temporary Myocardial Pacing Leads

Pediatric 6491 – Unipolar Pediatric Temporary Pacing Lead
The Model 6491 Unipolar Pediatric Temporary Pacing Lead is intended for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY.

Atrial 6492 – Unipolar Temporary Atrial Pacing Lead
The Model 6492 Unipolar Temporary Atrial Pacing Lead is intended for temporary atrial pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY.

Convenience 6494 – Unipolar Temporary Myocardial Pacing Wire
The Model 6494 Unipolar Temporary Myocardial Pacing Wire is intended for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY.

Bipolar Coaxial 6495 – Bipolar Temporary Myocardial Pacing Lead
The Model 6495 Bipolar Temporary Myocardial Pacing Lead is intended for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY.

Premium 6500 – Unipolar Temporary Myocardial Pacing Lead
The Model 6500 Unipolar Temporary Myocardial Pacing Lead is intended for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY.

The following information applies to all Streamline models:

Contraindications: There are no known general contraindications to temporary post-surgical pacing. The particular medical condition and anatomy of the patient, however, may dictate the lead system and implantation procedure to be used.

Warnings: An implanted pacing lead forms a direct current path to the myocardium. During pacing lead insertion and testing, use only battery-powered equipment specially designed for this purpose, to protect against fibrillation that may be caused by alternating currents. Line-powered equipment used in the vicinity of the patient must be properly grounded. Pacing lead connector pins must be insulated from any leakage currents that may arise from line-powered equipment. Avoid the possibility of unintentional contact between the pacing lead(s), including extension cable, and any equipment used as well as any conductive surface contact. Leaving the lead implanted for longer than 7 days may result in difficulty or inability to extract the lead and/or bleeding. Equipment/accessories connected to the Model 6495 shall comply with IEC 601-1-1, type CF.

Potential Complications: The possibility of dislodgement, lead fractures, threshold elevation and sensing inconsistency exists. Other potential complications include, but are not limited to, myocardial irritability, septicaernia and myocardial infections, myocardial bleeding and damage, especially during removal of the pacing lead(s).

Precautions: It is recommended that defibrillation equipment is readily available during temporary pacing lead insertion and removal.

The packaging should be inspected prior to use. Should the seal or package be damaged, contact the local Medtronic representative. This product should not be exposed to temperatures above 60°C (140°F)

Resterilization: The temporary pacing lead has been ethylene-oxide sterilized prior to shipment. Do not resterilize. Expired products shall be discarded.