Update my browser now. There is a risk of non sterile product and patient infection, in case any unutilized portions of product were to be re-used after first application. The issue is not common, affecting 0.33% of aortic implants using the Mosaic Porcine Aortic Bioprosthesis Model 305. 3: Conditional 5 More. The SimuForm ring provides semi-rigid posterior remodeling while offering a flexible anterior portion to accommodate motion. Aortic and Mitral Valve Replacement CSF Flow Control Valve, Fixed Pressure Medtronic, Inc., www.medtronic.com. Mosaic Porcine Bioprosthesis. Strength 3. Indications, Safety, and Warnings. The following postoperative precautionary measures are recommended: Hydroxylapatite is the basic inorganic constituent of living bone tissue. Mosaic Mitral Valve Model Aortic Valve Model heart valve Medtronic, Inc., www.medtronic.com. Respiratory, Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. It is recommended that EpiDisc and MeroGel QuickGel Otologic Dressing be used immediately after the opening of the pouch; discard any unused portion of the device. CVG EMEA Indications, Safety and Warnings | Medtronic Medtronic MRI Resource Library: Home Society for Medical Physics of the Netherlands (NVKF). "MR Conditional" MitraClips attached to hold margins of mitral valve leaflets together. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Be alert to the issue in your clinical decision-making and consider referring the patient to a relevant specialist, if required. The SimuPlus ring and band offer flexible solutions to mitral/tricuspid valve repair. Serious complications may arise either during or after surgery which may result in irreparable damage to these otologic structures and their functions causing irreversible partial or total loss of hearing. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. The patient should be advised of the importance of keeping the operative area clean and dry until healing is complete and dressings are removed. Allowing leaflets to remain soft and flexible, which protects the tissue from cyclic fatigue. We are always looking for ways to improve our website. EpiDiscis contraindicated in patients with hypersensitivity to the product. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. The Mosaic valve reflects the asymmetry of the native porcine valve. Patients For countries that use eIFUs , consult instructions for use at this website www.medtronic.com/manuals. MeroGelOtologic Packing is a space-occupying dressing and/or stent intended to separate mucosal surfaces, help control minimal bleeding, and act as an adjunct to aid in the natural healing process. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Medtronic Mosaic Porcine Aortic Bioprosthesis | Therapeutic Goods Mechanical testing of human cardiac tissue: some implications for MRI safety, Translational and rotational forces on heart valve prostheses subjected ex vivo to a 4.7 T MR system, Assessment of magnetic field (4.7T) induced forces on prosthethic heart valves and annuloplasty rings, Prosthetic heart valves: evaluation of magnetic field interactions, heating, and artifacts at 1.5T, State of the art of transcatheter mitral annuloplasty: present and future, Safety of magnetic resonance imaging in cardiac surgery patients: annuloplasty rings, septal occluders, and transcatheter valves (letter and response), 2020 ACC/AHA Guideline for the management of patients with valvular heart disease. We update our information and features frequently. Heart Valves and Annuloplasty Rings More. Central/Eastern Europe, Middle East & Africa, Next-generation flexible polymer stent that allows for absorption of stress produced during the cardiac cycle, Physiologic Fixation process that minimizes the stress applied to the leaflets during fixation*, Has stent posts that deflect to allow for easierknot tying near the posts in aortic replacements, Facilitates minimally invasive procedures, Improvingpreservation of valve structure and leaflet function, allowing it to function similar to a native valve, Allowing leaflets to remain soft and flexible which protects the tissue from cyclic fatigue, Roots are pressured at 40 mm Hg with glutaraldehyde, Radiopaque stent post eyelets, which provide visible coaxial markers during TAV-in-SAVprocedures, MR conditional, nonmetallic frame mitigates risk of corrosion between SAV and TAV stent materials, Interior-mounted leaflets mitigate potential risk of coronary obstruction. Note: Manuals can be viewed using a current version of any major internet browser. The hazard alert and recall only affect the Medtronic Mosaic Porcine Aortic Bioprosthesis Model 305 (all sizes and configurations, Standard and Ultra) and its associated sizing materials. As reported in theMosaic bioprostheis Instructions for Use. EpiFilmOtologic Lamina is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. THE List - MRI Safety With an updated browser, you will have a better Medtronic website experience. View indications, safety, and warnings for the IndigoOtologic Drill. With an updated browser, you will have a better Medtronic website experience. If there is any suspicion of oval window granuloma or fistuladuring the postoperative recovery period, an emergency exploratory tympanotomy and correction of the condition should be performed immediately. Various reports6-9have shown that the MB is a safe and well-performing device in the medium and intermediate terms. Guideline use of MRI in patients with implants. Ann Thorac Surg. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. For countries that use eIFUs, consult instructions for use at this websitemedtronic.com/manuals. Warnings and Precautions. Cardiovascular On this page: Information for consumers | Information for surgeons and cardiologists | Information for health professionals | Additional information | Reporting problems. Heart Valves Surgical. 1C. After use, dispose according to applicable national practice. AccessGUDID - DEVICE: MOSAIC ULTRA (00885074253244) PMA Monthly approvals from 2/1/2022 to 2/28/2022 Original Total: 1 Supplements Total: 68 30-Day Notice P200030/S007 02/22/2022 X - 30-Day Notice GORE EXCLUDER CONFORMABLE AAA ENDOPROSTHESIS (CEXC). It also: Our exclusive Physiologic Fixation* process mitigates biomechanical failures and promotes long-term valve durability by: Valve dimensions and geometryfacilitate future TAV-in-SAVreplacements. Potential Adverse Events: Certain complications may occur with heart valve procedures. Avoid packing external ear canal with adherent dressings or applying excessive pressure. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Surgical Heart Valve Repair and Replacement, Medtronic Open Pivot Aortic Valved Graft, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. The Evolut PRO self-expanding transcatheter aortic valve features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance. 310C31: Medtronic Mosaic 310 Cinch Mitral Valve, 31mm EpiFilm Otologic Lamina is contraindicated in patients with hypersensitivity to the product. Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolyticanemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis. Radiopaque stent post eyelets on the Mosaic valve provide visible markers to help correctly position the transcatheter valve during ViV procedures. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Biomaterials, Nasal Packing & Ear Packing, View indications, safety, and warnings for MeroGel, View indications, safety, and warnings for the IndigoOtologic Drill, View indications, safety, and warnings for the IPC, View indications, safety, and warnings for the NIM, OSSICULAR PROSTHESES (MIDDLE EAR AND STAPES IMPLANTS), Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. Specifically, considerable oversizing, or implanting a valve substantially larger than the native aortic annulus, can result in the alteration of normal leaflet movement as blood flowing through the native annulus might not properly match the size and/or shape of the inflow of the Mosaic Porcine Aortic Bioprosthesis Model 305. Nevertheless, the long-term effects of the Activent tube displaced into the middle ear are unknown. It is possible that these complications could lead to reoperation, explantation, permanent disability, and death. Patients with an INR of 1.5-2.0 had a >60% reduction in bleeding events and no increase in TE compared to patients with an INR of 2.0-3.0.*. Home In a prospective, multicenter, long-term follow-up observational study of 1,029 patients, the following outcomes were reported: Adverse events potentially associated with the use of bioprosthetic heart valves include: angina, cardiac arrhythmia, cardiac dysrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage (anticoagulant/antiplatelet related), leak (transvalvular or paravalvular), myocardial infarction nonstructural dysfunction (obstructive pannus ingrowth, suture dehiscence, inappropriate sizing, other), stroke, structural deterioration (calcification, leaflet tear, other) thromboembolism, valve thrombosis. Rie FC, Fradet G, Lavoie A, Legget M. Long-Term Outcomes of the Mosaic Bioprosthesis. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy.
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