medtronic mosaic valve mri safety

Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA The Mosaic bioprosthesis - based on more than 30 years of Medtronic tissue valve design expertise - is an excellent choice for surgeons looking for long-lasting durability, exceptional performance and implantability for aortic, mitral and MICS proced Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. An investigation has found that the sizing chart and associated sizing tools (known as 'obturators' or 'sizers') may have contributed to the selection of larger-than-optimal implants. (Case courtesy of Dr Matt A. Morgan, "MR Conditional" Cardioband C-shaped annuloplasty device being anchored in the mitral annulus. Heart Valves and Annuloplasty Rings More. The Instructions for Use for the modified Mosaic obturators/sizers has been updated to include the new sizing chart (iEOA chart). Reduced hearing or total deafness is at risk in such cases. 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. Additional factors that may contribute to durability are: The benefits of AOA tissue treatment have been demonstrated through animal testing. The implantation of oversized prosthetic valves can potentially result in the valve not functioning optimally. Products 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. Heart Valves . Be alert to the issue in your clinical decision-making and consider referring the patient to a relevant specialist, if required. Both FLEX H/A and dense HA can be manufactured to various specifications allowing for the reconstruction of the middle ear ossicular chain. The unique bileaflet valve design of the Medtronic Open Pivot mechanical heart valves eliminates recesses or cavities where a potential thrombus may form. The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. Older mechanical valves (such as Bj, rk-Shiley or caged-ball models,including some made ofstainless steel) may rarely be encountered, but like their modern counterparts are considered, Most common surgically implanted annuloplasty devices haveno metallic components and are, at all field strengths. 1.5,3: Safe More. Valve dimensions and geometry facilitate future ViV procedures. Long-Term Outcomes of Mosaic versus Perimount Mitral Replacements: 17-Year Follow Up of 940 Implants. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. (such as Revo MRI, SynchroMed, Endeavor, Mosaic, Delta, InterStim) by Device Type (such as pacemaker, stent, otology implants, drug pump) Warning: Do not use magnetic resonance imaging (MRI) on a patient who has an implanted device until you review the following: All conditions for use for all implanted devices "MR Conditional" MitraClips attached to hold margins of mitral valve leaflets together. If you, or someone you care for, have received a porcine aortic bioprosthesis and you are concerned about this issue, contact the treating surgeon or cardiologist for advice. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Crown PRT Aortic Pericardial Heart Valve LivaNova, www.livanova.sorin.com. Ear, Nose & Throat AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. The Mosaic bioprosthesis based on more than 30 years of Medtronic tissue-valve design expertise is an excellent choice for surgeons looking for long-lasting durability, exceptional performance and implantability for aortic, mitral, and MICS procedures. Heart Valves Surgical. Even very old stainless steel valves are likewise considered of no danger in MRI. The SimuForm ring provides semi-rigid posterior remodeling while offering a flexible anterior portion to accommodate motion. Heart Valves Surgical With an updated browser, you will have a better Medtronic website experience. EpiDiscTM Perforation Patch Kitis contraindicated in patients with hypersensitivity to the product. The largest leaflet of the Mosaic is intended to align with the patient's anterior mitral leaflet to accommodate ventricular flow. ON-X AORTIC HEART VALVE: 50% CLOSER TO A NORMAL INR1. Mosaic 29 It is recommended that MeroGel be used immediately after opening of the pouch; discard any unused portion of the device. 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. 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). The. A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional mitral heart valve. , chronic renal failure, hyperparathyroidism). The Mosaic Porcine Aortic Bioprosthesis Model 305 is an artificial valve used to replace faulty aortic heart valves. 3: Conditional 5 More. Avoid packing external ear canal with adherent dressings or applying excessive pressure. Adverse events potentially associated with the use of prosthetic heart valves include: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction, leaflet entrapment (impingement), transvalvular regurgitation, structural dysfunction, pannus, perivalvular leak, transvalvular leak, thrombosis, stroke, thromboembolism. A report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines. Note: Manuals can be viewed using a current version of any major internet browser. EpiDiscOtologic Laminais 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. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Contegra is an integrated valved conduit for reconstruction or replacement of the natural right ventricular outflow tract (RVOT) or replacement of a failed homograft or composite pulmonary conduit. 3: Conditional 5 More. Mosaic Mitral Bioprosthesis Model 310 is not affected. Cardiovascular It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Extreme caution must be exercised by the surgeon during surgery to safeguard against undesirable results and postoperative complications.implant should be trimmed (or a shorter implant selected) if it is too long for the vestibule to avoid any contact with sensitive inner ear structures. Mosaic Porcine Bioprosthesis. In the event that minor modifications of a dense H/A head or shaft are required, it is advisable to perform all trimming or contouring with a diamond burr using copious amounts of irrigation. They are classified as either bioprosthetic or mechanical. Surgical valve treatment for mitral and aortic valve disease The Epic Plus Mitral stented tissue valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native mitral heart valve. 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. It is important to consult the full system manuals for the most updated information. We do not review or control the content on non-Medtronic sites, and we are not responsible for any business dealings or transactions you have there. 1.5, 3: . Warning: Persons allergic to cobalt-chromium . The Tri-Ad 2.0 Adams tricuspid annuloplasty band repairs annular dilatation, preserving 3-D motion during the cardiac cycle while providing free wall support and remodeling. Higher-than-expected transvalvular gradients (>25 mmHg) associated with the Mosaic Procine Aortic Bioprosthesis Model 305 have occurred at a rate of 0.33% (3.3 reports per 1000 aortic implants). *Third-party brands are trademarks of their respective owners. To address the issue, Medtronic Australasia is recalling resources used to select appropriately sized devices for implantation. Medtronic, www.medtronic.com Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. The result is a unique bioactive material which provides excellent tissue interface and can be easily trimmed with a surgical knife. Update my browser now. The surgeon must use medical judgment and consider the patients medical history prior to a decision to surgically insert a ventilation tube. Note: Manuals can be viewed using a current version of any major internet browser. Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, Surgically correctable injury to the middle ear from trauma, The presence of middle ear infection which could result in displacement of the implant(s), Conductive hearingloss which may be restored by non-invasive methods. Healthcare Professionals Update my browser now. 3.0: Safe More . The artificial valve incorporates synthetic materials and porcine heart valve tissue. 1C. Note: Manuals can be viewed using a current version of any major internet browser. Society for Medical Physics of the Netherlands (NVKF). EpiFilm Otologic Lamina is indicated for myringoplastic and tympanoplastic surgical procedures. Click OK to confirm you are a Healthcare Professional. The Mosaic bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock II valve. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. INDICATIONS, SAFETY, AND WARNINGS Mosaic and Mosaic Ultra Bioprostheses Indications for Use For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. To prevent potential separation of the shoe component (if applicable), verify prosthesis shaft is fully seated within the shoe prior to placement. High-performance stent that allows for absorption of stress produced during the cardiac cycle. Mosaic & Mosaic Ultra Bioprostheses. Treatments & Therapies 1.5: Safe More . EpiDiscis contraindicated in patients with hypersensitivity to the product. Read MR Safety Disclaimer Before Proceeding, Currentlyavailable valves have either one or two tilting disks. Rie FC, Fradet G, Lavoie A, Legget M. Long-Term Outcomes of the Mosaic Bioprosthesis. It is recommended that MeroGel be used immediately after opening of the pouch; discard any unused portion of the device. Medtronic Xomed ossicular prostheses are indicated for the functional restoration of sound energy conduction in the middle ear as reconstructive devicesor artificial replacement for the natural ossicles of the middle ear. Update my browser now. Mosaic & Mosaic Ultra Bioprostheses For countries that use eIFUs , consult instructions for use at this website www.medtronic.com/manuals. * Compared to the Edwards SAPIEN 3 valve Cardiovascular Avoid packing external ear canal with adherent dressings or applying excessive pressure. Consumers and health professionals are encouraged to report problems with medical devices. Adverse events can include: angina, cardiac dysrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, infection other than endocarditis, transvalvular or paravalvular leak, myocardial infarction, nonstructural valve dysfunction (leaflet entrapment/impingement, obstructive pannus ingrowth, suture dehiscence, inappropriate sizing or positioning, or other), pericardial effusion or tamponade, prosthesis regurgitation, prosthesis stenosis, prosthesis thrombosis, stroke, structural valve deterioration (calcification, leaflet tear or perforation, or other), thromboembolism, tissue dehiscence, and transient ischemic attack. The Duran AnCore annuloplasty system combines more than 35 years of proven technology with features that make it easy to implant. LifeLine CardioVascular Technical Support, 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. The Contegra conduit offers a natural alternative for reconstruction or replacement of the natural right ventricular outflow tract (RVOT). Roots arepressurized at 40 mm Hg with glutaraldehyde. Safety Topic / Subject Cristallo Ideale Carotis Self-Expanding Stent Conical version . 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. Medtronic Australasia has updated both the iEOA Mosaic Aortic Bioprosthesis sizing chart and Mosaic obturators/sizers. Products It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. CSF Flow Control Valve, Fixed Pressure Medtronic, Inc., www.medtronic.com. Surgeons are advised to begin using the new iEOA sizing chart and modified Mosaic obturators/sizers for future implantations. Potential Adverse Events: Certain complications may occur with heart valve procedures. 1995; 16(6):722-724. A Medtronic Australasia field representative will contact surgeons about the new obturator/sizer set and sizing chart. Healthcare Professionals ), Clogging of the tube which may require removal and replacement (membrane-style tubes are more susceptible to this complication and only for use in ears evacuated of effusion), Persistent perforation of the tympanum after tube extrusion, Granulomatosis reaction of the tympanum necessitating tube removal, Failure of the tube to self-extrude requiring medical intervention for removal, Allergic reaction may occur in patients with metals sensitivity, Dislocation of the tube into the middle ear cavity, The surgeon is encouraged to carefully choose a tube size, style, and material to meet the needs of each specific clinical situation, while minimizing adverse effects, Larger tube diameters and increasing flange size may increase the chances of prolonged tube retention and/or residual perforation. This includes: Handle (234 mm length) pliant, without locknut to be used with Mosaic or Mosaic Ultra prostheses, Handle (368 mm length) pliant, without locknut to be used with Mosaic or Mosaic Ultra prostheses, Mosaic Mitral Obturator Set (no handles, no tray). Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Indications, Safety, and Warnings, for Middle Ear Surgery and Other Otologic Procedures. This device has been approved as a humanitarian use device (HUD) in the United States. Company Name: MEDTRONIC, INC. Primary DI Number: 00885074253244 Issuing Agency: GS1 Commercial Distribution End Date: August 29, 2016 Device Count: 1 Labeler D-U-N-S Number*: 006261481 * Terms of Use Device Description: VALVE 305U23 MOSAIC AOR ULTRA US CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. It may also be used to replace a previously implanted prosthetic mitral valve. Update my browser now. At one time worries existed that an electromagnetic phenomenon known as the "Lenz effect" could inhibit the opening and closing of valves (such as the Bjrk-Shiley) made of metal disks or leaflets. After use, dispose according to applicable national practice. Home Download Brochure (opens new window) Product Details Undeniably Durable 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). Indications, Safety, and Warnings Product Details Medtronic Open Pivot Aortic Valved Graft (AVG) Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Edwards MIRA Mechanical Valve Mitral, Model 9600, size 33 mm heart valve Pre-6000 series Starr-Edwards valves were once considered contraindicated for MR imaging, but this prohibition has now been removed. Medtronic Manuals: Region Manual Library Instructions for use and product manuals for healthcare professionals Please select your region. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. Home Central/Eastern Europe, Middle East & Africa, Heart Valves Transcatheter Aortic (TAVI). Instructions for Use. The Tri-Ad 2.0 Adams Tricuspid annuloplasty band repairs annular dilatation preserving 3D motion during the cardiac cycle, while providing free wall support and remodeling. The artificial valve incorporates synthetic materials and porcine heart valve tissue. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Federal law (USA) restricts this device to sale by or on the order of a physician. If you are treating a patient who has received a Mosaic Porcine Aortic Bioprosthesis Model 305, reassure them that it is not common (occurring at a rate of 0.33%). 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. Aortic and Mitral Valve Replacement If you have not been contacted or want to order the new materials directly, contact Medtronic Australasia on 1800 668 670. Advanced Discussion (show/hide) References The Contour 3Dannuloplasty ring is a remodeling ring with a physiological tricuspid valve shape a 2-D shape and 3-D curvature based on CT data from functional tricuspid valves. No direct clinical evaluation of the benefits of AOA treatment in humans has been conducted. Products Mosaic and Mosaic Ultra Bioprostheses. Update my browser now. No clinical data is available which evaluates the long-term impact of the Physiologic Fixation process or the impact of AOA treatment in patients. Reults, based on almost 10 years of clinical experience using dense hydroxylapatite in the middle ear, suggest that implants can be placed in direct contact with the tympanic membrane without the added risk of extrusion. On this page: Information for consumers | Information for surgeons and cardiologists | Information for health professionals | Additional information | Reporting problems. Am J Oto. Healthcare Professionals The patient should be advised of the importance of keeping the operative area clean and dry until healing is complete and dressings are removed. Can some patients with cardiac pacemakers undergo MRI. The Mosaic bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock II valve. The Avalus bioprosthesis is a pericardial aortic surgical valve designed for better overall performance, improved implant experience, and a contemporary design to facilitate future valve-in-valve (ViV). There is a risk non sterile product and patient infection, in case any unutilized portions of product were to be re-used after first application. The MRI examination must be performed using the following parameters: 1.5-Tesla or 3-Tesla, only Whole body averaged specific absorption rate (SAR) of 2-W/kg, operating in the Normal Operating Mode for the MR system Maximum imaging time, 15 minutes per pulse sequence (multiple sequences per patient are allowed)

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