Severe aortic stenosis occurs when the aortic valve leaflets become stiff and thickened and have difficulty opening and closing, making the heart work harder to pump blood to the rest of the body. Reach out to lifeline cardiovascular tech support with questions. Damage may result from forceful handling of the catheter. It is comprised of the xenograft, processed to render the tissue non-viable, attached to an expandable metal framework, which is implanted with an included catheter, and when in situ, may be expanded with a balloon or self-expand. Aortic transcatheter heart valve bioprosthesis, stent-like framework. It is comprised of the xenograft, processed to render the tissue non-viable, attached to an expandable metal framework, which is implanted with an included catheter, and when in situ, may be expanded with a balloon or self-expand. Transcatheter Aortic Heart Valves These legacy and new design features provide the following sealing mechanisms: The Evolut TAVI platform demonstrates EOAs that are consistently large and may have a benefit for healthier, more active patients. Please visit: appliedradiology.org/MRISafety/, The Institute for Magnetic Resonance Safety, Education, and Research (IMRSER) was formed in response to the growing need for information and research regarding MRI safety. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis Medtronic, Inc., www.medtronic.com/MRI An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral, subclavian, aortic) or transapical access while the heart is beating. In addition, the Evolut FX system incorporates a redesigned catheter tip for a smoother insertion profile, a more flexible delivery system that allows for 360-degree freedom of motion, with a stable, predictable deployment. Actual results may differ materially from anticipated results. Special Storage Condition, Specify: Keep dry, Special Storage Condition, Specify: Keep away from sunlight, Storage Environment Temperature: more than 0 Degrees Celsius, Device Size Text, specify: Valve Size 26 MM. It is possible that some of the products on the other sitenot be licensed for sale in Canada. Central/Eastern Europe, Middle East & Africa. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. During Use After the procedure, administer appropriate antibiotic prophylaxis as needed for patients at risk for prosthetic valve infection and endocarditis. Implantation of the bioprosthesis should be avoided in patients with aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) of >30 for right subclavian/axillary access or >70 for femoral and left subclavian/axillary access. January 2016;102(2):107-113. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Typically devices associated with implantation (e.g., catheter, introducer) are included. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. Cardiovascular Read our disclaimer for details. You just clicked a link to go to another website. More information (see more) Third attempt must be a complete recapture and retrieval from patient. It is possible that some of the products on the other site are not approved in your region or country. The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. Conduct the procedure under fluoroscopy. Up to 80% deployment. Hemodynamic and physical performance during maximal exercise in patients with an aortic bioprosthetic valve: comparison of stentless versus stented bioprostheses. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. Update my browser now. Today, the Evolut FX system further refines a trusted platform with key product and procedural enhancements that make the self-expanding system easier to use with enhanced visualization capabilities for orientation and depth," said Jeffrey Popma, M.D., vice president and chief medical officer for the Coronary & Renal Denervation business and the Structural Heart & Aortic business, which are part of the Cardiovascular Portfolio at Medtronic. IMRSER promotes awareness, understanding, and communication of MR safety issues through education and research. Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For transfemoral access, use caution in patients who present with multiplanar curvature of the aorta, acute angulation of the aortic arch, an ascending aortic aneurysm, or severe calcification in the aorta and/or vasculature. Transcatheter Aortic Heart Valves 2020 Medtronic. Circulation. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. With a design built on the proven Evolut platform, the Evolut PRO+ system features: Lowest delivery profile Anatomical characteristics should be considered when using the valve in this population. Brand Name: Evolut PRO+ Version or Model: EVPROPLUS-29US Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: MEDTRONIC COREVALVE LLC Primary DI Number: 00763000211127 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 079527231 * Terms of Use With an updated browser, you will have a better Medtronic website experience. The CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems are contraindicated in patients who cannot tolerate Nitinol (titanium or nickel), gold (for Evolut FX Systems alone), an anticoagulation/antiplatelet regimen, or who have active bacterial endocarditis or other active infections. You just clicked a link to go to another website. From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves Cardiol Ther. Broadest annulus range based on CT derived diameters. GMDN Names and Definitions: Copyright GMDN Agency 2015. The safety and effectiveness of the CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems have not been evaluated in the pediatric population. More information (see more) Class 2 Device Recall CoreValve Evolut PRO PLUS Delivery Catheter System: Date Initiated by Firm: June 11, 2021: Create Date: July 09, 2021: Recall Status 1: Open 3, Classified: Recall Number: Z-2043-2021: Recall Event ID: . If you continue, you will leave this site and go to a site run by someone else. 4 Based on these data, the FDA expanded the indications for CoreValve and the next generation Evolut systems to include patients at intermediate or greater risk for open-heart surgery. Home Access instructions for use and other technical manuals in the Medtronic Manual Library. The safety and efficacy of a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis implanted within a transcatheter bioprosthesis have not been demonstrated. 1.5, 3: Conditional 8 More. For direct aortic access, ensure the access site and trajectory are free of patent RIMA or a preexisting patent RIMA graft. With an updated browser, you will have a better Medtronic website experience. Implanting a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis in a degenerated surgical bioprosthetic valve (transcatheter aortic valve in surgical aortic valve [TAV-in-SAV]) should be avoided in the following conditions: The degenerated surgical bioprosthetic valve presents with: a significant concomitant paravalvular leak (between the prosthesis and the native annulus), is not securely fixed in the native annulus, or is not structurally intact (e.g., wire form frame fracture); partially detached leaflet that in the aortic position may obstruct a coronary ostium; stent frame with a manufacturer-labeled inner diameter <17mm. Shellock R & D Services, Inc. email Quickly search hundreds of MRI safety related articles. Evolut PRO+ Transcatheter Aortic Valve, The next generation EvolutTM PRO+ transcatheter aortic valve system provides industry-leading hemodynamics allowing your patients to return to activity faster.1,2,3, 8.8% Flameng, W, et al. Proper sizing of the devices is the responsibility of the physician. Refer to the Instructions for Use for available sizes. These studies reported consistent data regarding the safety and efficacy of the CoreValve system, and several confirmed its durability out to at least five years. Implant & Device Testing MAGNETIC RESONANCE SAFETY TESTING SERVICES is a highly experienced MRI-safety testing company that conducts comprehensive evaluations of implants, devices, objects, and materials. Severe aortic stenosis often reduces a patient's quality of life and limits their daily activities. Special Storage Condition, Specify: Keep Away from Sunlight, Special Storage Condition, Specify: Keep Dry, Device Size Text, specify: Valve Size 29 MM. The Evolut PRO system design has one important addition an external tissue wrap is added around the outer sealing zone of the nitinol frame which, combined with the platform design, provides advanced sealing. Avoid freezing. Manual Library Instructions for use and product manuals for healthcare professionals Transcatheter Aortic Valve Replacement (TAVI), Central/Eastern Europe, Middle East & Africa. GeneralImplantation of the CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems should be performed only by physicians who have received Medtronic CoreValve Evolut R, Evolut PRO+, or Evolut FX training. 9850 NW 41st Street, Suite 450, Doral, FL 33178 Reproduced with Permission from the GMDN Agency. Impact of patient-prosthesis mismatch on exercise capacity in patients after bioprosthesis aortic valve replacement. Prior to the procedure, measure the patients creatinine level. The Evolut PRO+ system is currently the only TAVI platform indicated to treat annulus ranges up to 30 mm diameter and has the ability to treat the broadest annulus range* of any commercially available TAVI system. For best results, use Adobe Acrobat Reader with the browser. Click OK to confirm you are a Healthcare Professional. GO TO THE LIBRARY (opens new window) An office chair was in the wrong place - at ANY time! AND DISABLING STROKES AT 30 DAYS3, Evolut Pro+ Experience Typically devices associated with implantation (e.g., catheter, introducer) are included. Update my browser now. Cardiovascular Advanced sealing The next-generation self-expanding transcatheter aortic valve replacement (TAVR) system, the CoreValve Evolut PRO was designed with an outer pericardial skirt to improve valve-sealing performance. Today, the Evolut PRO+ valve design means no tradeoffs. Healthcare Professionals The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Heart. Aortic transcatheter heart valve bioprosthesis, stent-like framework. Indications, Safety, & Warnings. English and Spanish forms are Failure to implant a device within the sizing matrix could lead to adverse effects such as those listed below. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. See the Evolut R System. for access down to 5.0 mm vessels with the 23-29 mm valves. These legacy and new design features provide the following sealing mechanisms: The external wrap increases surface contact with native anatomy, providing advanced sealing. In addition, the EnVeo PRO delivery system provides you the option to recapture and reposition for more accurate placement. As the first Medtronic self-expanding TAVR system approved in China, the Evolut PRO system approval is based on clinical data from more than 32,000 patients, which showed high survival, low rates of stroke, minimal paravalvular leak (PVL) and excellent hemodynamics (blood flow). A steel oxygen tank is never permitted inside of the MRI system room. Reproduced with Permission from the GMDN Agency. Cardiovascular Safety; Emergency Preparedness; International Programs; News & Events; Training and Continuing Education; Inspections . More information (see more) Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its newest-generation, self-expanding transcatheter aortic DUBLIN, Aug. 24, 2021 /PRNewswire/ --Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its newest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system, the Evolut FX TAVR system. Update my browser now. Visit: IMRSER.org, Videos Available on IMRSER include: MRI Safety Training Programs for Levels 1 and 2 MR Personnel, What to Expect During Your MRI, Projectile/Missile Effect videos, and Superconducting magnet quenching shown from both inside and outside the MR system room. Avoid exposing to extreme fluctuations of temperature. It is possible that some of the products on the other site are not approved in your region or country. For subclavian access, patients with a patent left internal mammary artery (LIMA) graft must present with access vessel diameters that are either 5.5mm when using models ENVEOR-L-US/D-EVPROP2329US/D-EVOLUTFX-2329 or 6mm when using model ENVEOR-N-US or 6.5mm when using models D-EVPROP34US/D-EVOLUTFX-34. With performance at its core, the CBG features a continuous, tapered core and pre-shaped curve for secure deployment. for all valve sizes with the addition of the external tissue wrap to the 34 mm valve. The safety and effectiveness of a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis implanted within a failed preexisting transcatheter bioprosthesis have not been demonstrated. Evolut PRO+ TAVI System The bioprosthesis size must be appropriate to fit the patients anatomy. The Evolut PRO+ system is indicated to treat annulus ranges up to 30 mm in diameter and has the ability to treat the broadest annulus range* of any commercially available TAVR system. Safety Info ID# Safety Topic / Subject Article Text 179: Heart Valves and Annuloplasty Rings: 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. Products Find more detailed TAVRinformation, educationalresources, and tools. MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. Evolut PRO+ Transcatheter Aortic Valve, The next generation EvolutTM PRO+ transcatheter aortic valve system provides industry-leading hemodynamics allowing your patients to return to activity faster.1,2,3, Evolut PRO+ TAVI System Full commercial launch is anticipated in early calendar year 2022. The Medtronic CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems are indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (e.g., STS predicted risk of operative mortality score 8% or at a 15% risk of mortality at 30 days). General surgical risks applicable to transcatheter aortic valve implantation: abnormal lab values (including electrolyte imbalance, allergic reaction to antiplatelet agents, contrast medium, or anesthesia, exposure to radiation through fluoroscopy and angiography. 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. Device Dimensions Operating and Storage Conditions Device Identifiers FDA Pre-market Approvals/Notifications & deNovo Premarket Approval: P130021 FDA Product Code NPT Aortic valve, prosthesis, percutaneously delivered Sterilization Device Entry Metadata On-Brand Devices [Evolut PRO+] Trademark Results [Evolut] 2022 FDA.report - (01:09), Learn how the Evolut platform is designed to go beyond procedural outcomes to benefit your patients. Evaluate bioprosthesis performance as needed during patient follow-up. Listing a study does not mean it has been evaluated by the U.S. Federal Government. The commercial name of the Evolut R device is Medtronic CoreValve Evolut R System, the commercial name of the Evolut PRO+ device is Medtronic Evolut PRO+ System, and the commercial name of the Evolut FX device is Medtronic Evolut System. Caution: Federal Law (USA) restricts these devices to the sale by or on the order of a physician. EVOLUT PRO+ SYSTEM Transcatheter Aortic Valve Implantation (TAVI) The next generation Evolut TM PRO+ transcatheter aortic valve system provides industry-leading hemodynamics allowing your patients to return to activity faster. Update my browser now. August 2006;92(8);1022-1029. Object Description Object Status Safety Topic / Subject Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. You may also call800-961-9055 for a copy of a manual. - (03:26). From a design built on a proven platform1, the EVOLUT PRO+ system provides the performance and outcomes you need to help patients live life to the fullest. For best results, use Adobe Acrobat Reader with the browser. Your use of the other site is subject to the terms of use and privacy statement on that site. Avoid freezing. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Search by the product name (e.g., Evolut) or model number. The external wrap increases surface contact with native anatomy, providing advanced sealing. If you continue, you may go to a site run by someone else. Products The objectives of this study are to: a) evaluate and correlate the severity of paravalvular leak (PVL) assessed by both cardiac MRI and transthoracic echocardiography (TTE) after transcatheter aortic valve replacement (TAVR) with Medtronic Evolut-R or Evolut PRO bioprostheses; b) assess the inter and intraobserver variability of both imaging An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral, subclavian, aortic) or transapical access while the heart is beating. The Evolut PRO valve features an external tissue wrap added to the proven platform design. Your Resource for MRI Safety, Bioeffects,& Patient Management. Up to 80% deployment. Search by the product name (e.g., Evolut) or model number. Like its predecessor (Evolut PRO+), the newest system includes four valve sizes for the largest indicated patient treatment range and the lowest delivery profile currently on the market. In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. +353 (0)1 4047 113 info@evolut.ie. ClinicalTrials.gov Identifier: NCT02701283 document.write(new Date().getFullYear()) by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. For applicable products, consult instructions for use on manuals.medtronic.com. The Evolut PRO+ system is currently the only TAVI platform indicated to treat annulus ranges up to 30 mm diameter and has the ability to treat the broadest annulus range* of any commercially available TAVI system. Heart. In addition, our exceptional valve design is taking patient outcomes above and beyond contributing to our industry-leading hemodynamics. 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. Special Storage Condition, Specify: Store the bioprosthesis at room temperature. Transcatheter Aortic Heart Valves. It is possible that some of the products on the other site are not approved in your region or country. Aortic valve prosthesis-patient mismatch and exercise capacity in adult patients with congenital heart disease. See the CoreValve Evolut R, the CoreValve Evolut PRO and the Evolut PRO+ device manuals for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. Click OK to confirm you are a Healthcare Professional. By choosing to accept, you acknowledge that you are a Certified Healthcare Professional. Avoid exposing to extreme fluctuations of temperature. For information, visit MagneticResonanceSafetyTesting.com. Aortic transcatheter heart valve bioprosthesis, stent-like framework. Third attempt must be a complete recapture and retrieval from patient. Broadest annulus range* Corevalve Evolut PRO Bioprosthesis, Heart Valve Prosthesis. The Evolut platform delivers industry-leading hemodynamics, maintains the lowest delivery profile, and is indicated to treat the broadest annulus range* on the market. Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. Cardiac Monitors Deep Brain Stimulation Systems Implantable Cardiac Devices Neurological Shunts Spinal Cord Stimulation Systems MRI GUIDELINES AND MANUALS You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. Frank.ShellockREMOVE@MRIsafety.com. Patients must present with transarterial access vessel diameters of 5mm when using models ENVEOR-US/D-EVPROP2329US/D-EVOLUTFX-2329 or 5.5mm when using model ENVEOR-N-US or 6mm when using models D-EVPROP34US/D-EVOLUTFX-34, or patients must present with an ascending aortic (direct aortic) access site 60mm from the basal plane for both systems. Data on file (>20 clinical trials with over 20000 patients enrolled). Hemodynamic and physical performance during maximal exercise in patients with an aortic bioprosthetic valve: comparison of stentless versus stented bioprostheses. Transcatheter Aortic Valve Implantation (TAVI), Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Assists in accurate positioning of the valve, Features a 1:1 response for immediate feedback between the deployment knob and the movement of the capsule, Provides you the option to recapture and reposition. 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. The valve can be partially or fully recaptured up to three times prior to the point of no recapture. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Ascending aorta diameter >4.5 cm 3. "The self-expanding, supra-annular Evolut platform has evolved considerably over time and has brought heart teams innovative features like recapturability, an expanded size matrix, and advanced valve sealing to help minimize paravalvular leak. Access instructions for use and other technical manuals in the Medtronic Manual Library. Visit Amazon.com for more information or to order. Contact Us; About Us; Group; Prevent kinking of the catheter when removing it from the packaging. The Evolut TAVR platform (including the Evolut R, Evolut PRO, Evolut PRO+, and Evolut FX) is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low) in the U.S. Limited commercial release is planned for the fall with a full launch anticipated in early 2022. Healthcare Professionals Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. CoreValve Evolut R Transcatheter Aortic Valve Heart Valve Prosthesis . Safety and efficacy of this valve have not previously been compared to its predecessor, the Evolut R valve. * Third party brands are trademarks of their respective owners. Testing procedures are in accordance with the guidelines from The American Society for Testing and Materials (ASTM) International. Home The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). 1,2,3 DOWNLOAD BROCHURE (opens new window) Indications, Safety, and Warnings Overview Meet the Evolut PRO+ SYSTEM See the CoreValve Evolut R, the CoreValve Evolut PRO and the Evolut PRO+ device manuals for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. Heart. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. J Am Coll Cardiol. Manuals can be viewed using a current version of any major internet browser. Recapture and reposition +1 (305) 500-9328, Evolut FX TAVR System Adds Innovative Features to Enhance Ease-of-Use and Predictable Valve Deployment, https://www.medtronic.com/us-en/index.html?intcmp=mdt_com_country_selector_dropdown_atlasr22016, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers. We currently do not have this item in stock, but we can email you as soon as it is available. Update my browser now. January 2016;102(2):107-113. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, R System, the commercial name of the Evolut, PRO+ System, and the commercial name of the Evolut, 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, myocardial infarction, cardiac arrest, cardiogenic shock, or cardiac tamponade, coronary occlusion, obstruction, or vessel spasm (including acute coronary closure), cardiovascular injury (including rupture, perforation, tissue erosion, or dissection of vessels, ascending aorta trauma, ventricle, myocardium, or valvular structures that may require intervention), emergent surgical or transcatheter intervention (e.g., coronary artery bypass, heart valve replacement, valve explant, percutaneous coronary intervention [PCI], balloon valvuloplasty), prosthetic valve dysfunction (regurgitation or stenosis) due to fracture; bending (out-of-round configuration) of the valve frame; underexpansion of the valve frame; calcification; pannus; leaflet wear, tear, prolapse, or retraction; poor valve coaptation; suture breaks or disruption; leaks; mal-sizing (prosthesis-patient mismatch); malposition (either too high or too low)/malplacement prosthetic valve migration/embolization, delivery catheter system malfunction resulting in the need for additional recrossing of the aortic valve and prolonged procedural time, delivery catheter system component migration/embolization, stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), or other neurological deficits, individual organ (e.g., cardiac, respiratory, renal [including acute kidney failure]) or multi-organ insufficiency or failure, major or minor bleeding that may require transfusion or intervention (including life-threatening or disabling bleeding), vascular access-related complications (e.g., dissection, perforation, pain, bleeding, hematoma, pseudoaneurysm, irreversible nerve injury, compartment syndrome, arteriovenous fistula, or stenosis), conduction system disturbances (e.g., atrioventricular node block, left bundle-branch block, asystole), which may require a permanent pacemaker.

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