The adverse events potentially associated with the use ofprosthetic aortic 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. Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. Refer to the Instructions For Use packaged with each valve for a complete listing of warnings and precautions. Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. Heart Valve Replacement - Surgical Medtronic reserves the right to deny or disable any user name or password or request for any user name or password. ) Shiono M, Sezai Y, Sezai A, et al. 2001; 4(4):346-353. With an updated browser, you will have a better Medtronic website experience. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Tex Heart Inst J. You shall at all times use the Licensed Software in compliance with all applicable laws. Your use of the other site is subject to the terms of use and privacy statement on that site. 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. Products You are also responsible for confirming that the Programmer User has obtained any necessary patient consent before allowing you to view any patient information via the Licensed Software. Emery RW, Krogh CC, Jones DJ, Nicoloff DM, Blake DP, Arom KV. The reoperation rate was 1.2%. The Hemashield Woven Double Velour Vascular Graft is not approved for use as a coronary artery replacement. LifeLine CardioVascular Technical Support, Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Medtronic Open Pivot Aortic Valved Graft (AVG), Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Medtronic Open Pivot Aortic Valved Graft (AVG), Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. Evaluation of valve sound and its effects on ATS prosthetic valves in patient's quality of life. Contraindications: The Medtronic Open Pivot Heart Valve is contraindicated in patients unable to tolerate anticoagulation therapy. Multi-institutional experience of the ATS Open Pivot bileaflet valve in Japan. Important Safety Information. Medtronic Open Pivot Aortic Valved Graft (AVG) 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. Premarket Approval (PMA). Int J Artif Organs. MRI Resources, For clinicians whose patients have a Medtronic system. Clinical results of a large series of ATS valve implants. 2001;4(4):346-352. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Note: Manuals can be viewed using a current version of any major internet browser. Van Nooten GJ, Caes F, Francois K, et al. Premarket Approval (PMA). Healthcare Professionals On-X Life Technologies, Inc. P000037 S059: 03/24/2022: medtronic open pivot heart valve, medtronic open p. MEDTRONIC ATS MEDICAL, INC. P990046 S063: 03/11/2022: open pivot mechanical valve (ophv), open pivot aor. AccessGUDID - Open Pivot (00643169078109)- MHV 500DM25 STD MITRAL. Heart Valves Surgical Proven Graft Material 2001;4(4):346-352. The initial United States experience with the ATS mechanical cardiac valve prosthesis. For countries that use eIFUs, consult instructions for use at www.medtronic.com/manuals. Heart Valves Surgical J Heart Valve Dis. Five-year follow up of the ATS mechanical heart valve. 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. In: Krian A, Matloff JM, Nicoloff DM, eds. 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). Hancock Pericardial Mitral Model T410 Haynes alloy heart valve Medtronic Inc. Minneapolis, M. 1.5: Int J Artif Organs. Int J Artif Organs. September 1993;106(3):427-433. Emery RW, Van Nooten GJ, Tesar PJ. Shiono M, Sezai Y, Sezai A, et al. In vitro behavior of mechanical heart valves in 1.5-T superconducting magnet. By installing or using the Licensed Software to view the Programmer screen information, registering a username and password in connection with the Medtronic RemoteView feature, or clicking on any acceptance button in connection herewith, you, a Remote Viewer, agree to be bound by all of the terms and conditions set forth in these Terms of Use (this Agreement). The graft should not be implanted in patients with a known sensitivity to products of bovine origin. Sezai A, Shiono M, Orime Y, et al. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Medtronic Open Pivot Heart Valves Product Specifications medtronic open pivot Standard Heart valve Aortic Standard Tissue Annulus Orifice Inner Geometric Valve Size Model Diameter (B) Diameter (A) Orifice Area (mm) Number (mm) (mm) (cm2) 19 500FA19 19.5 14.8 1.55 21 500FA21 21.5 16.8 2.02 23 500FA23 23.5 18.8 2.56 ATS Medical Open Pivot Bileaflet Heart Valve Mitral, Model 500DM29 Standard Valve pyrolytic carbon heart valve ATS Medical Minneapolis, M. 1.5: Security/Privacy of Patient Data. 2,6,9 Excellent hemodynamics: In-vivo studies demonstrate excellent hemodynamics. Cardiovascular Effects of magnetic fields used in MRI on 15 prosthetic heart valves. November 1999;22(11):754-763. Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. Limitations of Liability. As of 2015, MRI conditions that are considered safe for patients with a St. Jude heart valve include a static magnetic field of 1.5 Tesla or 3.0 Tesla, a maximum spatial gradient less than or equal to 3,000 Gauss per centimeter, and a maximum whole-body averaged specific absorption rate of 2.0 watts per kilogram for 15 minutes of scanning in The Medtronic ATS Open-Pivot valve has a spherical convex pivot guide to enable blood to wash away rather than pool around the hinges. You are solely responsible for and will use your best efforts in maintaining the confidentiality and security of any copies of the Licensed Software as well as any user name, password credentials, and any Session Keys that can be used in accessing the Licensed Software, a Medtronic server, or any information from a Programmer. 2,9,10 perceval sutureless heart valve: CORCYM Canada Corp. P150011 S026: 11/21/2022: exoseal vascular closure device: Cordis US Corporation: P100013 S026: 10/28/2022: vibrant soundbridge system: Med-el Elektromedizinische Ger: P990052 S026: 10/11/2022: r3 delta ceramic acetabular system: Smith & Nephew, Inc. P150030 S026: 09/21/2022: relayplus . , chronic renal failure, hyperparathyroidism). Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Products Note: Manuals can be viewed using a current version of any major internet browser. Medtronic does not review or control the content on the other website, and we are not responsible for any business dealings or transactions you have there. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. The Suture Superstore that provides surgical disposables, sutures & more. Clinical results of a large series of ATS valve implants. Westaby S, Parry A, Giannopoulos N, Pillai R. Replacement of the thoracic aorta with collagen-impregnated woven Dacron grafts. 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. Potential 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. Five-year follow up of the ATS mechanical heart valve. 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 www.medtronic.com/manuals. 1999; 22:754-763. In this article, we present the results of 15 years of follow-up of patients who have undergone ATS heart valve replacement at our hospital. Products 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. Eur J Cardio-thorac Surg. 1A [10L(02)] Printspec k - 5.25 x 9.875 inches. If the Licensed Software is used connection with NayaMed customers or devices, this Agreement shall be directly between you and NayaMed with respect to those uses. March 2004;13(2):231-238. Many heart valve prostheses and annuloplasty rings have been evaluated for MR issues, especially with regard to the presence of magnetic field interactions associated with exposure to MR systems opera, AAV-2 Heart Valve Aortic heart valve prosthesis Arbor Surgical Technologies, Inc. Irvine, CA, AccuFit Mitral Valve Replacement DeviceMarvel Medical Technologies, Irvine, CA, ACURATE TF (Transfemoral) Aortic Bioprosthesis Symetis SA, www.symetis.com, AHK 7700, Model 7700 heart valveMedtronic, www.medtronic.com, AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com, AMEND Mitral Annuloplasty Ring, All SizesValcare Medical LTD., www.valcaremedical.com, AnnuloflexAnnuloplasty RingSize 36 mmL004032A 36MSulzer Carbomedics, Inc., www.sorin.com, AnnuloflexSize 26 mmAnnuloplasty RingL001285A 26MModel AF800Sulzer Carbomedics, Inc., www.sorin.com, AnnuloFloMitral Annuloplasty DeviceSize 36Model AR-736TitaniumSulzer Carbomedics, Inc., www.sorin.com, AnnulofloSize 26 mmAnnuloplasty RingS011896A 26MSulzer Carbomedics, Inc., www.sorin.com, AnnulofloSize 36 mmAnnuloplasty RingS013460A 36MSulzer Carbomedics, Inc., www.sorin.com, Annuloplasty Ring, Models RNG5 and RNG7Dynamic Annuloplasty Ring SystemMiCardia, www.micardia.com, Annuloplasty ringtitaniumheartSulzer Medica and Sulzer Carbomedics, www.sorin.com. Heart Surg Forum. 1,2 Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form. Medtronic Open Pivot Heart Valve Instructions for Use. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. Open Pivot Mechanical Heart Valves. Kelly SG, Verdonck PR, Vierendeels JA, Riemslagh K, Dick E, Van Nooten GG. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. You just clicked a link to go to another website. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death. Eur J Cardiothorac Surg. F 708.478.3519. Indications: For patients who require replacement of their native or prosthetic aortic and/or mitral valves. Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. LifeLine CardioVascular Technical Support, Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Medtronic Open Pivot Mechanical Heart Valves, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Medtronic Open Pivot Mechanical Heart Valves, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. MEDTRONIC ATS MEDICAL, INC. P990046 S062: 03/10/2022 View Product Details Indications, Safety, and Warnings Overview Bileaflet Valve The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. Other bileaflet valves use cavity pivots, which can provide areas of stasis where potential platelet aggregation can occur.4,5Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form.5,6While cavity pivots rely on mechanical sweeping and high-velocity leakage jets, with the Open Pivot design, the unimpeded flow of blood provides for a continuous passive washing.7,8. Each time you log in to the Licensed Software, Medtronic will collect information about your activity, including in an aggregated log or database, regarding you and your session, including your name, username, computer name, IP address, operating system details, and session details (including transferring and sharing activity, start and end times, view only or control activity, and any chat messages between or among any Active Remote Viewers. 1996; 2(1):51-58. MRI Resources For clinicians whose patients have a Medtronic system VIEW MRI TECHNICAL MANUALS (opens new window) MRI INFORMATION BY DEVICE TYPE Cardiac Monitors Deep Brain Stimulation Systems Implantable Cardiac Devices Neurological Shunts Spinal Cord Stimulation Systems MRI GUIDELINES AND MANUALS Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur.1,2Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form.2,3While cavity pivots rely on mechanical sweeping and high-velocity leakage jets, with the Open Pivot design, the unimpeded flow of blood provides for a continuous passive washing.4,5, Continuous passive washing provides for gentle treatment of blood cells and low levels, In-vivo studies demonstrates improved hemodynamic performance following device implant.6-8, Solid pyrolytic carbon orifice and strengthening band provides for thin yet strong orifice and large geometric orifice areas (GOAs).6,9. Click Continue to close this window and view the sites content. Ann Thorac Cardiovasc Surg. If not approved, please exit this site. Hemashieldis a registered trademark of MAQUET Cardiovascular, LLC. You agree that Medtronic may store this personal information about you on a Medtronic server, including a server located in the United States of America. ) Emery RW, Petersen RJ, Kersten TE, et al. Open Pivot Aortic Valved Graft The Hemashield*Woven Double Velour graftis made with a low-porosity graft material to improve hemostasis.6,7Excellent resorption rates facilitate healing.6The graft material also offers exceptional handling characteristics. Eur J Cardiothorac Surg. Krian A. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Kandemir O et al., St. Jude Medical and Carbomedics mechanical heart valves in the aortic position comparison of long term results. Safety Topic / Subject Article Text 179: . At any time upon Medtronics request (including via a notice on a Medtronic website), you agree to promptly delete and terminate use of any and all copies of the Licensed Software. The user name and password are personal to you and must not be shared with anyone else. CAUTION:Federal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. The Medtronic Open Pivot heart valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves. Products The unique bileaflet valve design of the Medtronic Open Pivotmechanical heart valves eliminates recesses or cavities where a potential thrombus may form. If you submit any comments or ideas to Medtronic, in the absence of a separate agreement regarding such submissions, you grant to Medtronic an unrestricted, royalty-free, irrevocable license to use, reproduce, display, perform, modify, transmit, and distribute such ideas in any medium and agree that Medtronic is free to use them for any purpose. Convenient accessories include nine white-handled, single-endedstandard heart valve sizers. MEDTRONIC ATS MEDICAL, INC. P990046 S065: 10/21/2022: open pivot heart valve, open pivot aortic valved g. MEDTRONIC ATS MEDICAL, INC. P990046 S064: 03/10/2022: medtronic open pivot heart valve, medtronic open p. MEDTRONIC ATS MEDICAL, INC. P990046 S063: 03/11/2022: open pivot mechanical valve (ophv), open pivot aor. You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. data, and the Medtronic valves are no exception. 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. U.S. Food & Drug Administration. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Advancing the Technology of Bileaflet Mechanical HeartValves. All information that you provide in connection with such registration must be complete, accurate, and truthful. The Medtronic Open Pivot mechanical heart valves represent a fundamental change in bileaflet valve design. Miscellaneous. A three-dimensional analysis of flow in the pivot regions of an ATS bileaflet valve. Single-plane orifice facilitates valve seating and implant regardless of suture technique. For additional information please refer to the Instructions for Use provided with the products or contact your local Medtronic representative. georgia ad valorem tax family member | | absorbed crossword clue 7 letters. Medtronic Hall Model A7700 Aortic Valve heart valve Medtronic Heart Valve Division Minneapolis, M With no tapers or pleats, the Medtronic Open Pivot AVG allows for easy anastomosis anywhere on the graft. Emery RW, Krogh CC, Jones DJ, et al. Term, Termination, Modifications, and Support. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation. 1996;10(8):660-665. Update my browser now. Westaby S, Van Nooten G, Sharif H, Pillai R, Caes F. Valve replacement with the ATS open pivot bileaflet prosthesis. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Even very old stainless steel valves are likewise considered of no danger in MRI. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990046. For countries that use eIFUs , consult instructions for use at this website www.medtronic.com/manuals. Cardiovascular You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. Please consult the approved indications for use. The ATS Open Pivot Heart Valve was first sold in international markets in 1992, and subsequently granted FDA clearance to sell in the United States in 2000. Ann Thorac Cardiovasc Surg. 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 initial experience with the ATS Medical mechanical cardiac valve prosthesis. The initial United States experience with the ATS mechanical cardiac valve prosthesis. (4) Hassler M, et al. Abstract Background: ATS Medical, Inc, developed a mechanical heart valve that has been in use since 1992. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. Email: Corporate.UDI@medtronic.com CLOSE . ATS Medical, Inc. Pre-market Approval Application Summary of Safety and Effectiveness: 2000. Healthcare Professionals Other bileaflet valves use cavity pivots, which can provide areas of statis where potential platelet aggregation can occur.1,2Open Pivot valves, on the other hand, have no recesses or cavities where a potential thrombus can form.2,3While cavity pivots rely on mechanical sweeping and high-velocity leakage jets, with the Open Pivot design, the unimpeded flow of blood provides for a continuous passive washing.4,5, Continuous passive washing provides for gentle treatment of blood cells and low levels, In-vivo studies demonstrates improved hemodynamic performance following device implant.6-8, Solid pyrolytic carbon orifice and strengthening band provides for thin yet strong orifice and large geometric orifice areas (GOAs).6,9. Home Open Pivot Mechanical Heart Valve. Eur J Cardiothorac Surg. 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). New York: Springer Verlag; 1998:53-71. Unlike other bileaflet valves, which use cavity pivots, the Medtronic Open Pivotaortic valved graft (AVG) has no recesses or cavities in the pivot area where thrombogenesis can occur.1,2This allows for continuous passive washing and gentle treatment of blood cells, resulting in low levels of hemolysis and thromboembolic events.1,3, In-vivo studies demonstrate excellent hemodynamics.3-5. Medtronic Open Pivot Heart Valve Valve cardiaque Herzklappe Vlvula card Home Training, education, and collaboration on the treatment of mitral and tricuspid valve disease. Krian A. Comparative in vivo study on the healing qualities of four different presealed vascular prostheses. Heart Surg Forum. Advancing the Technology of Bileaflet Mechanical Heart Valves: Springer Verlag; 1998:53-71. J Heart Valve Dis. 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. Unique axis of suspension results in leaflet movement responsive to physiological demands; Gentle, passive washing ensures complete washing of the pivot in both open and closed positions; Most patients cannot hear the sound of their valve after implantation; Low levels of hemolysis and thromboembolic events MEDTRONIC ATS MEDICAL . Jude Medical, Inc.www.sjm.com, AuraGen Cortical Surface Electrodes, Cortical Grid Electrodes, Cortical Strip Electrodes, Platinum Depth ElectrodesIntegra NeuroSciences, www.integralife.com. You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. LifeLine CardioVascular Thus at present, most centers consider all implanted heart valves and annuloplasty rings conditionally safe for MR imaging up to 3.0T, and do not require any waiting period after surgery before they can be scanned. Emery RW, Petersen RJ, Kersten TE, et al. 1996;10(8):660-665. Home Healthcare Professionals Surgical Heart Valve Repair and Replacement 2003;75(2):444-452. Logging of Session Activity. Int J Artif Organs. Washington D.C.: U.S. Food and Drug Administration; 2000. The Medtronic Open Pivot aortic valved graft is contraindicated in patients unable to tolerate anticoagulation therapy or who exhibit a sensitivity to polyester or materials of bovine origin. Kelly SGD, Verdonck PR, Vierendeels JAM, et al. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session. ) LifeLine CardioVascular 1996;10(8):660-665. Single-plane orifice facilitates valve seating and implant regardless of suture technique. Accessed April 20, 2021. This Agreement shall be governed by and interpreted, construed, and enforced in accordance with the laws of the State of Minnesota (exclusive of the choice of law rules thereof). Certain complications may occur with heart valve procedures. Update my browser now. J Heart Valve Dis. Accessed April 20, 2021. 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. Safety Topic / Subject Atriasept Closure Device Cardia, Inc. Eagan, MN . 2009;18(4):445-452. You acknowledge that the Licensed Software is not the exclusive method of viewing information from the Programmer and that the Licensed Software is not the exclusive method by which to obtain a patients implanted cardiac device data, including any data on the Programmer. 2012/OCT/04 at 10:52 a.m. Doc number: M951906A001 Rev. More R and Haubold A. J Heart Valve Dis. You agree that Medtronic may store any personal information about you on a Medtronic server, including a server located in the United States of America. ) It is possible that some of the products on the other site are not approved in your country. Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. This device may be used to replace a previously implanted prosthetic heart valve or conduit. By installing and using the Licensed Software, you represent that you have permission to do so from any associated clinic, hospital, or medical practice and that your use of the Licensed Software complies with any policies or requirements of such associated clinic, hospital, or medical practice.