For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. Healthcare Professionals The issue is not common, affecting 0.33% of aortic implants using the Mosaic Porcine Aortic Bioprosthesis Model 305. Medtronic Heart Valve Division Minneapolis, M. 3.0: Safe More. 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. Rie FC, Fradet G, Lavoie A, Legget M. Long-Term Outcomes of the Mosaic Bioprosthesis. 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 To safeguard against postoperative sensorineural hearing loss, extreme care must be taken to avoid traumatizing the inner ear structures by unnecessarily contacting the inner ear structures with surgical instruments or the implant(s) or through the removal of perilymph from the vestibule. "MR Conditional" MitraClips attached to hold margins of mitral valve leaflets together. Complications which may occur include, but are not limited to: A high degree of surgicalskill is required for the proper implantation of any ossicular prostheses. Mosaic and Mosaic Ultra Bioprostheses. 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 Cardiovascular With an updated browser, you will have a better Medtronic website experience. It is possible that some of the products on the other site are not approved in your region or country. AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. A subset of these valves have required explantation within five years of implantation at an overall occurrence rate of 0.1% (one explant per 1000 aortic implants). Products 2. 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) Heart Valves and Annuloplasty Rings More. Warning: Persons allergic to cobalt-chromium or nickel may suffer an allergic reaction specifically to the AP360 style device. Important Safety Information. The largest leaflet of the Mosaic is intended to align with the patient's anterior mitral leaflet to accommodate ventricular flow. 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. 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. Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. Safety of silver oxide-impregnated Silastic tympanostomy tubes. On this page: Information for consumers | Information for surgeons and cardiologists | Information for health professionals | Additional information | Reporting problems. 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. Healthcare Professionals The result is a unique bioactive material which provides excellent tissue interface and can be easily trimmed with a surgical knife. 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. Healthcare Professionals It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Heart Valves Surgical Central/Eastern Europe, Middle East & Africa, Heart Valves Transcatheter Aortic (TAVI). Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. With an updated browser, you will have a better Medtronic website experience. The manufacturer is unwilling to provide an MR safety statement, so these must be considered "MR Unsafe." As a precaution against implant extrusion through the tympanum, tissue grafts should be used as an interface between the implant and the tympanum. Your use of the other site is subject to the terms of use and privacy statement on that site. Home The Profile 3D annuloplasty system has a unique asymmetrical 3D remodeling ring design based on the annular geometry of normal human mitral annuli. To prevent potential separation of the shoe component (if applicable), verify prosthesis shaft is fully seated within the shoe prior to placement. 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. Mosaic Mitral Valve Model Aortic Valve Model heart valve Medtronic, Inc., www.medtronic.com. (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 Warnings and Precautions. Contraindications: The AVG is contraindicated in patients unable to tolerate anticoagulation therapy. Pre-6000 series Starr-Edwards valves were once considered contraindicated for MR imaging, but this prohibition has now been removed. No direct clinical evaluation of the benefits of AOA treatment in humans has been conducted. The Streamline family from Medtronic is designed for post-surgical temporary pacing. We are always looking for ways to improve our website. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. PRODUCT DETAILS EXCEPTIONAL DESIGN After use, dispose according to applicable national practice. 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. The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations, except those practicing in France as some of the content is not in compliance with the French Advertising law N2011-2012 dated 29th December 2011, article 34. Allowing leaflets to remain soft and flexible, which protects the tissue from cyclic fatigue. Update my browser now. Rie FC, Fradet G, Lavoie A, Legget M. Long-Term Outcomes of the Mosaic Bioprosthesis. View indications, safety, and warnings for MeroGelInjectable Bioresorbable Nasal Dressing/Sinus Stent and Otologic Gel. Heart Valves Surgical. Provides improved visibility for proper implant orientation, which may reduce the risk of complications. The Mosaic Porcine Aortic Bioprosthesis Model 305 is an artificial valve used to replace faulty aortic heart valves. Reconstruction or replacement of all or part of the ossicular chain may be necessary to correct structural damage of the middle ear ossiclesor conductive hearing loss resulting from a number of pathologic conditions, including but not limited to: Certain conditions may preclude the selection of ossicular prostheses implants as a means of restoring conductive hearing loss including: Surgery of the middle ear involves manipulation of fragile temporal bones and exposes inner ear structures to the risk of surgical trauma and infections. March 2018;105(3):763-769. 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). 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. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Surgeons and cardiologists should continue to follow-up with their patients as per their usual practice and in accordance with published guidelines. Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves. 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. Contraindications: None known . Edwards MIRA Mechanical Valve Mitral, Model 9600, size 33 mm heart valve 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%). You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device. The asymmetrical design of Mosaic offers one wider leafletspaced at 135 with an interstrut distance of 18.4 mm. Jude Medical St. Paul, M, Aortic ValveSize 16 mmA419529D 16ASulzer Carbomedics, Inc., www.sorin.com, Apical ConnectorModel 174Aheart valveMedtronic Heart Valve DivisionMinneapolis, M. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. If you are located outside the United States, see the device manual (opens new window) for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. 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. Both FLEX H/A and dense HA can be manufactured to various specifications allowing for the reconstruction of the middle ear ossicular chain. Download Brochure (opens new window) Product Details Undeniably Durable The Mosaic bioprosthesis based on more than 30 years of Medtronic tissue-valve design expertise is a great option for surgeons seeking exceptional long-term durability, excellent hemodynamics, and a smooth implanting experience. 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). For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. Medtronic.com Contact Medtronic Terms of Use Privacy Statement Patient Implant Information Previous Versions of Manuals 2023 Medtronic Products 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. Cardiovascular For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Additional factors that may contribute to durability are: The benefits of AOA tissue treatment have been demonstrated through animal testing. Object Status Conditional 5. EpiDisc is indicated for myringoplastic and tympanoplastic surgical procedures. Patients CSF Flow Control Valve, Fixed Pressure Medtronic, Inc., www.medtronic.com. Update my browser now. Training, education andcollaboration on the treatment of mitral and tricuspidvalve disease. Ann Thorac Surg. Heart Valves and Annuloplasty Rings More. Mosaic & Mosaic Ultra Bioprostheses. Ear, Nose & Throat Products Products It is possible that these complications could lead to reoperation, explantation, permanent disability, and death. Additional factors that may contribute to durability are: Our innovative Cinch implant system furthercapitalizes on the valves flexible stent to facilitatevalve implantation, particularly through a tightsinotubular space. Sapien* device deployed inside Mosaic mitral. Medtronic Australasia is recalling the resources and will replace them with updated versions. Be alert to the issue in your clinical decision-making and consider referring the patient to a relevant specialist, if required. Medtronic Australasia has updated both the iEOA Mosaic Aortic Bioprosthesis sizing chart and Mosaic obturators/sizers. Note green deployment catheter. Hancock bioprosthetic valvedconduits are for the reconstruction of congenital or acquired cardiac and great vessel malformations or pathologies for right-heart applications. Ann Thorac Surg. Like any ceramic material, there is some risk of breaking or cracking the implant under certain conditions. Freestyle is our most physiologic 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. 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. Healthcare Professionals The Hancock II and Hancock II Ultra are for patients who require replacement of their native or prosthetic aortic and/or mitral valves. Home 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. Potential Adverse Events: Certain complications may occur with heart valve procedures. Note: Manuals can be viewed using a current version of any major internet browser. MR Conditional, nonmetallic frame mitigates risk of corrosion betweensurgical valve and transcatheter valve stent materials. The valve design allows blood to flow through the annulus encountering only tissue, not obstructive components such as the stent and sewing ring. "MR Safe", nonmetallic porcine valve for surgical implantation, "MR Conditional" Transcatheter Aortic Valve Replacement (TAVR), "MR Conditional" Bi-leaflet mechanical valve. Medtronic Australasia has written to cardiologists and surgeons advising them of the issue. Module 1: MRI in patients with a prosthetic heart valve, annuloplasty. They are classified as either bioprosthetic or mechanical. EpiFilm Otologic Lamina is indicated for myringoplastic and tympanoplastic surgical procedures. The Mosaic Porcine Aortic Bioprosthesis Model 305 is an artificial valve used to replace faulty aortic heart valves. Crown PRT Aortic Pericardial Heart Valve LivaNova, www.livanova.sorin.com. Medtronic Manuals: Region Manual Library Instructions for use and product manuals for healthcare professionals Please select your region. The CG Future is an annuloplasty system for mitral valve repair, designed to predictably remodel the annulus to maintain apposition of the anterior and posterior leaflets. 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. The SimuForm ring provides semi-rigid posterior remodeling while offering a flexible anterior portion to accommodate motion. The Mosaic bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock II valve. High-performance stent that allows for absorption of stress produced during the cardiac cycle. The operative ear is the better or only hearing ear. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. "MR Conditional" mitral annuloplasty device on chest x-ray. Heart Valves . The Contegra conduit offers a natural alternative for reconstruction or replacement of the natural right ventricular outflow tract (RVOT). A Medtronic Australasia field representative will contact surgeons about the new obturator/sizer set and sizing chart. Edwards MIRA aortic and mitral mechanical valves Models 3600, 3600f, 3600u, 9600 Edwards Lifesciences LLC www.edwards.com . , chronic renal failure, hyperparathyroidism). Medtronic, www.medtronic.com Product names on this page are trademarks or registered trademarks of Medtronic. The Duran AnCore annuloplasty system combines more than 35 years of proven technology with features that make it easy to implant. Proprietary AOAanti-calcification tissue treatment that mitigates calcification and protects the tissue. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. heart valve Medtronic Inc. Minneapolis, M. 1.5: Safe More. EpiFilm Otologic Lamina is contraindicated in patients with hypersensitivity to the product. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. AOA Tissue Treatment Video 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. 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. The SimuForm ring is elevating mitral repair its flexible anterior partaccommodates anterior motion, while the semi-rigid posterior part enables remodeling. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Click OK to confirm you are a Healthcare Professional. 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. Healthcare Professionals It is recommended that MeroGel be used immediately after opening of the pouch; discard any unused portion of the device. 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. Product names on this page are trademarks or registered trademarks of Medtronic. August 2020;110(2):508-515. MRI safety Heart valve products US MRI safety information - heart valve products Outside the US MRI safety information - heart valve products Contact technical support Contact the Edwards Lifesciences technical support department at 800-822-9837 (USA) or 949-250-2500 for any additional information regarding MRI safety of our products. All other bileaflet aortic valve anticoagulation should be managed at an INR of 2.0-3.0. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. It is recommended that EpiFilm be used immediately after the opening of the pouch; discard any unused portion of the device. Important Labeling Information for United States. With an updated browser, you will have a better Medtronic website experience. Artificial cardiac valves may be implanted by either an open surgical or transcatheter approach. The SimuPlus ring and band offer flexible solutions to mitral/tricuspid valve repair. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS). Am J Oto. In any case, because most of these valves were implanted over 40 years ago, few, if any, patients are still alive who received them. The Simplici-T annuloplasty system offers a first-of-its-kind approach to mitral and tricuspid valve repair. 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. This device has been approved as a humanitarian use device (HUD) in the United States. The implantation of oversized prosthetic valves can potentially result in the valve not functioning optimally. We pay our respects to them and their cultures, and to all Elders both past and present. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement.

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