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. For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. No clinical data is available which evaluates the long-term impact of the Physiologic Fixation process or the impact of AOA treatment in patients. Home Home 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. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA Allowing leaflets to remain soft and flexible, which protects the tissue from cyclic fatigue. It is possible that these complications could lead to: reoperation, explantation, permanent disability, heart failure, death. Sapien* device deployed inside Mosaic mitral. Heart Valves and Annuloplasty Rings More. "MR Conditional" mitral annuloplasty device on chest x-ray. Note: Manuals can be viewed using a current version of any major internet browser. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. VALVE 310C31 MOSAIC MIT CINCH US Medical Device Identification FDA .report PMA PMN De Novo MAUDE GUDID NDC DailyMed Drug Applications MOSAIC GUDID 00613994688996 VALVE 310C31 MOSAIC MIT CINCH US MEDTRONIC, INC. FDA.report GUDID MEDTRONIC, INC. 00613994688996 Heart Valves Surgical The Mosaic bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock II valve. 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) 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 Read MR Safety Disclaimer Before Proceeding, Currentlyavailable valves have either one or two tilting disks. 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. Indications: The Medtronic Open Pivot Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Protects tissue from inadvertent damage and prevents entanglement with the sub-valvular apparatus. The unique bileaflet valve design of the Medtronic Open Pivot mechanical heart valveseliminates recesses or cavities where a potential thrombus may form. (From Wikipedia.com), The results of numerous investigations have demonstrated that metal-containing valves. Ann Thorac Surg. Medtronic Australasia has written to cardiologists and surgeons advising them of the issue. The TGA cannot give advice about an individual's medical condition. For countries that use eIFUs, consult instructions for use at this websitemedtronic.com/manuals. 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. The SimuForm ring provides semi-rigid posterior remodeling while offering a flexible anterior portion to accommodate motion. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. 3: Conditional 5 More. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Like any ceramic material, there is some risk of breaking or cracking the implant under certain conditions. Home Pathologic conditions for which ventilation tubes are indicated include but are not limited to: Some conditions for which ventilation tubes may not be the therapy of choice include: The Medtronic Xomed ActiventAntimicrobial Ventilation Tube was evaluated in a 12-month study in the middle ear of animals.1While the Activent tube was formed of silicone and silver oxide and was shown to be bacteriocidal/bacteriostatic, the study showed that the material produced no significant adverse effects compared to silicone control material. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. AorTechAorticModel 3800TitaniumHeart ValveAortech Ltd.Strathclyde, U.K. AorTechMitralModel 4800titaniumheart valveAortech Ltd.Strathclyde, U.K. Aortic Mitroflow Synergy PCAortic Pericardial Heart ValveSize 19 mmSulzer Carbomedics, Inc., www.sorin.com, Aortic Mitroflow Synergy PCAortic Pericardial Heart ValveSize 29 mmSulzer Carbomedics, Inc., www.sorin.com, Aortic SJM Regent ValveMechanical Heart ValveSize 27 mm27AGN-751Rotatable AorticStandard Cuff-Polyester, AGNSt. Ann Thorac Surg. March 2018;105(3):763-769. Note green deployment catheter. Radiopaque stent post eyelets on the Mosaic valve provide visible markers to help correctly position the transcatheter valve during ViV procedures. 1.5, 3: . 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. Object Category Heart Valves and Annuloplasty Rings. The Mosaic bioprosthesis is an evolution in durability and implantability, based on the proven platform of the Hancock II valve. Provides improved visibility for proper implant orientation, which may reduce the risk of complications. Healthcare Professionals Accelerated structural 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, or hyperparathyroidism). Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Artificial cardiac valves may be implanted by either an open surgical or transcatheter approach. 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. The surgeon must use medical judgment and consider the patients medical history prior to a decision to surgically insert a ventilation tube. Mosaic Porcine Bioprosthesis. 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. 3: Conditional 5 More. Advanced Discussion (show/hide) References Roots arepressurized at 40 mm Hg with glutaraldehyde. If you continue, you may go to a site run by someone else. 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. 1.5: Safe More . 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. "MR Safe", nonmetallic porcine valve for surgical implantation, "MR Conditional" Transcatheter Aortic Valve Replacement (TAVR), "MR Conditional" Bi-leaflet mechanical valve. Medtronic.com Contact Medtronic Terms of Use Privacy Statement Patient Implant Information Previous Versions of Manuals 2023 Medtronic With an updated browser, you will have a better Medtronic website experience. 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. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device. 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. It is recommended that EpiDisc be used immediately after the opening of the pouch; discard any unused portion of the device. MeroGel is contraindicated in patients with hypersensitivity to the product. Update my browser now. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Am J Oto. Avoid packing external canal with adherent dressings or applying excessive pressure. As a precaution against implant extrusion through the tympanum, tissue grafts should be used as an interface between the implant and the tympanum. A report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines. ), 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. Medtronic Neurosurgery Goleta, CA. You just clicked a link to go to another website. They are classified as either bioprosthetic or mechanical. On this page: Information for consumers | Information for surgeons and cardiologists | Information for health professionals | Additional information | Reporting problems. 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). EpiDiscTM Perforation Patch Kitis contraindicated in patients with hypersensitivity to the product. Mosaic and Mosaic Ultra Bioprostheses. Surgical Heart Valve Repair and Replacement After use, dispose according to applicable national practice. The surgeon must fully assess the risks and benefits to the patient prior to the decision to implant ossicular prostheses. Your use of the other site is subject to the terms of use and privacy statement on that site. 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. Safety Topic / Subject Heart Valves and Annuloplasty Rings. 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. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. * Compared to the Edwards SAPIEN 3 valve PRODUCT DETAILS EXCEPTIONAL DESIGN Surgeons are advised to begin using the new iEOA sizing chart and modified Mosaic obturators/sizers for future implantations. Surgeons performing middle ear surgery should have received specific training in the reconstruction and replacement of the middle ear ossicles prior to attempting implantation of Medtronic Xomed ossicular prostheses. With an updated browser, you will have a better Medtronic website experience. To prevent potential separation of the shoe component (if applicable), verify prosthesis shaft is fully seated within the shoe prior to placement. The patient should be advised of the importance of keeping the operative area clean and dry until healing is complete and dressings are removed. Products 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. Instructions for Use. Physiologic Fixation, our advanced tissue fixation process, to mitigate biomechanical failures and promote long-term valve durability by: Improving preservation of valve structure and leaflet function, allowing it to function similar to a native valve. 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. Edwards MIRA Mechanical Valve Mitral, Model 9600, size 33 mm heart valve 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. The adverse events potentially associated with the use of prosthetic aortic heart valves include, but are not limited to: angina, cardiac arrhythmia, endocarditis, hemolysis, hemolytic anemia, anticoagulant-related hemorrhage, myocardial infarction, leaflet entrapment (impingement), nonstructural dysfunction, pannus, perivalvular leak, transvalvular regurgitation, structural dysfunction, thrombosis, stroke, thromboembolism. Medtronic Open Pivot Mechanical Heart Valves The unique bileaflet valve design of the Medtronic Open Pivot mechanical heart valves eliminates recesses or cavities where a potential thrombus may form. No direct clinical evaluation of the benefits of AOA treatment in humans has been conducted. 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. At a minimum, the following precautions must be taken: Following surgery, both surgeon and patient must be alert to any sign of adverse effects from surgery and the patient should be advised of the proper care of the operative ear. If using an MRI device, see the MRI technical manual . 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. Chole RA and Brummet RE, et al. The artificial valve incorporates synthetic materials and porcine heart valve tissue. 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. More information (see more) Safety Info ID# Safety Topic / Subject Article Text 179: . Mosaic 29 A Medtronic Australasia field representative will contact surgeons about the new obturator/sizer set and sizing chart. Mosaic Mitral Valve Model Aortic Valve Model heart valve Medtronic, Inc., www.medtronic.com. Click OK to confirm you are a Healthcare Professional. Technical Support. Even very old stainless steel valves are likewise considered of no danger in MRI. Update my browser now. 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. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. 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. FLEX H/A is a homogenous, nonporous composite of two well-known biomaterials: hydroxylapatite and silicone. Heart Valves Surgical. 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. Freestyle is our most physiologic valve. In any case, because most of these valves were implanted over 40 years ago, few, if any, patients are still alive who received them. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. The Medtronic Open Pivot aortic valved graft unites a fundamentally different bileaflet heart valve design with leading graft technology for exceptional implantability. Safety of silver oxide-impregnated Silastic tympanostomy tubes. Healthcare Professionals View indications, safety, and warnings for MeroGelInjectable Bioresorbable Nasal Dressing/Sinus Stent and Otologic Gel. Specific instructions on how to maintain proper hygiene of the operative ear should be given to the patient. 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. Indications, Safety, and Warnings. However, the popular Carpentier-Edwards (. View indications, safety, and warnings for the IPCSystem (lntegrated Power Console). 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. 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. Implantation of substantially oversized Mosaic Porcine Aortic Bioprostheses Model 305 can potentially lead to cases of higher-than-expected transvalvular gradients. heart valve Medtronic Inc. Minneapolis, M. 1.5: Safe More. Suitable for Future Interventions Valve dimensions and geometry enable future valve-in-valve (ViV) replacements. Heart Valves Surgical. Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. 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.*. 1220016001 Rev. Healthcare Professionals The implantation of oversized prosthetic valves can potentially result in the valve not functioning optimally. Similarly, a tissue graft should be employed over the stapes footplate, or alternatively, over the oval window in stapedectomy procedures to help prevent perilymph fistula or leakage of perilymph. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Warning: The graft should not be implanted in patients with a known sensitivity to products of bovine origin. 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. Society for Medical Physics of the Netherlands (NVKF). Published clinical experience demonstrates impressive long-term performance in all age groups. Offers smooth needle penetration and suture placement with a fluffy, conformable cuff. Update my browser now. 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). Adverse events potentially associated with the use of vascular grafts include, but are not limited to: 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. Hancock bioprosthetic valvedconduits are for the reconstruction of congenital or acquired cardiac and great vessel malformations or pathologies for right-heart applications. 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. MeroGel Otologic Packing is indicated for use in the middle ear and external ear canal following canalplasty, myringoplasty, tympanoplasty, and stapes and mastoid surgery. Ann Thorac Surg. EpiFilm Otologic Lamina is indicated for myringoplastic and tympanoplastic surgical procedures. The Simplici-T annuloplasty system offers a first-of-its-kind approach to mitral and tricuspid valve repair. Cardiovascular Note: Manuals can be viewed using a current version of any major internet browser. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. The artificial valve incorporates synthetic materials and porcine heart valve tissue. Contraindications: None known . 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. Update my browser now. The SimuPlus ring and band offer flexible solutions to mitral/tricuspid valve repair. 1.5,3: Safe More. Cardiovascular Rie FC, Fradet G, Lavoie A, Legget M. Long-Term Outcomes of the Mosaic Bioprosthesis. Note: Manuals can be viewed using a current version of any major internet browser. Subsequent surgical procedures may be required to correct these conditions if possible. 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. 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. 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. 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.
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