ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Precautions
Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. Medical Device Recalls, Recalls, Market Withdrawals and Safety Alerts, Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI RDS VENOUS STENT System for Potential of Stent Migration, VICI VENOUS STENT System (VICI SDS) and VICI RDS VENOUS STENT System, Distribution Dates: September 21, 2018 to April 9, 2021, Health care providers using the VICI VENOUS STENT System and VICI RDS VENOUS STENT System, Patients who have a procedure using the VICI VENOUS STENT System or VICI RDS VENOUS STENT System, Immediately discontinue use of the device, Remove all affected units from inventory and secure them, Complete the company's Verification Form to acknowledge receipt and report products that will be returned, Package affected products for shipping and contact the local Boston Scientific representative to arrange for their return. AccessGUDID - DEVICE: Ascerta Firm (08714729861775) A non-bioabsorbable tubular device intended to be implanted in the common and/or external iliac artery (ies) to maintain arterial patency and luminal diameter in patients with symptomatic atherosclerotic disease. On April 12, 2021, Boston Scientific Corporation sent an Urgent Medical Device Recall Notification to customers asking them to: Customers with questions should contact their Boston Scientific sales representative. It is required to program the device to MRI Settings as part of the MRI scan workflow. This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. NATICK, Mass., Oct. 23, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) reports twelve-month clinical endpoint data from the ORION trial, which demonstrated robust safety and effectiveness outcomes for the Epic Self-Expanding Nitinol Stent System in patients with obstructed iliac arteries. f@ PDF Table of Contents - WATCHMAN The site is secure. Search for arrhythmia, heart failure and structural heart IFUs. Instructions for Downloading Viewers and Players. MRI at 3T or 1.5T may be performed immediately following the implantation of the Epic Stent. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. By using this site, you consent to the placement of our cookies. This includes continuous monitoring of the patient's hemodynamic function. Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729802976 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: Ureteral Stent CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers Customer Contact [?] (0.89mm) guidewires. {}(;]xjx$,&\I'esU7;O*G@MI9YO?V6t N=9nq}^I pk2f5RVw>bd.Ms@G7'^,UPX_4~KO$rS8ILEn5WVu >V:RD/L u 9cwM\^$h IOK
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Our ability to provide a total iliac solution, with the market-leading Express LD Stent and our expansive balloon catheter portfolio, allows Boston Scientific to offer a complete line of advanced solutions to physicians and patients.". The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. Overview of the ELUVIA Drug- Eluting Stent (DES) III. As a result, DFUs for stent systems containing metal usually recommend a waiting period of approximately two months from the time of implantation until an MRI can be performed safely. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX. "The FDA approval of the timing on MRI exams is a significant development for interventional cardiologists and their patients," said Paul LaViolette, Boston Scientific Chief Operating Officer. PDF Summary of Safety and Effectiveness Data (Ssed) They appreciate the radial force of the stent, which helps allow the artery to stay open, and the flexibility in its design, which helps in deliverability. These devices are considered MR Unsafe. Sterile. All rights reserved. Boston Scientific Epic Stent Demonstrates Positive Clinical Outcomes You can search by model number or product category. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Class 3 Device Recall Sentinol Nitinol Biliary Stent System It employs an innovative Tandem Architecture, which is engineered to provide excellent stent flexibility while maintaining predictable radial force characteristics across a variety of stent sizes. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Instructions for Downloading Viewers and Players, Class 3 Device Recall Sentinol Nitinol Biliary Stent System. Boston Scientific's Express 2 (bare-metal) stent system also received approval for immediate MRI exams. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . Read our privacy policy to learn more. Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. Platinum Chromium Coronary Stent System (Monorail) Device Procode: Applicant's Name and Address: NIQ . The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). AccessGUDID - DEVICE: Tria Soft (08714729959915) 300 Boston Scientific Way . 38948-8607. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Proper patient monitoring must be provided during the MRI scan. Conditional 6 More. CAUTION: Do not bring any external control devices, such as the Merlin Patient Care System (PCS) Programmer, SJM MRI Activator handheld device, or Aveir Link Module into the scanner magnet room (Zone IV). Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. Catalog No. To look up your patients system, use the Product Search tool to determine whether your patients device and leads (if applicable) are safe for an MRI. 38948-8607. CAUTION: These products are intended for use by or under the direction of a physician. 1.5 . Stent delivery system (SDS): A system that delivers a biliary stent to a target site within the bile duct and then deploys the stent. Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729959915 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 021717889 * Terms of Use Device Description: Ureteral Stent With Side Holes 6Fx28CM CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. PARIS, May 22, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) reports positive results from two trials evaluating new, innovative drug-eluting stent (DES) technologies, which are emerging treatment options for coronary heart disease. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. MRI safety testing has shown that the REBEL Stent is MR Conditional and that 1.5,3:
of Abbott Medical Japan GK. The following countries were contacted regarding the recall and all reported that no accounts had affected product in their possession: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Hong Kong, India, Indonesia, Vietnam, New Zealand, Israel, Korea, Malaysia, Mexico, Philippines, Singapore, South Africa, Taiwan, Thailand, Turkey, Uruguay, Andean & Caaribbean Countries, Cyprus, Balkins, Puerto Rico, Bahrain, Egypt, Jordan, Kuwait, Lebanon, Morocco, Oman, Pakistan, Qatar, Saudi Arabia, Syria, Tunisia, Yemen, United Arib Emirates. The Epic Stent is compatible with 6F sheaths, and the stent delivery system is compatible with 0.035 inch guidewires. VICI VENOUS STENT System (VICI SDS) and VICI RDS VENOUS STENT System Models and Serial Numbers: See Medical Device Recall Database Entry Distribution Dates: September 21, 2018 to April 9, 2021 Be sure to check the lead combination(s) (if applicable) to ensure you select the correct settings. It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. Due to the use of intense magnetic fields in MRI examinations, implanted medical devices that contain metal may be subject to potential migration and heating within the body. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. Follow the checklist instructions within Merlin PCS Programmer. 5-year data for. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. Duplex ultrasound, which measures blood flow through arteries and veins, showed a primary patency (level of un-obstruction) of 94.4 percent, indicating the vast majority of treated lesions remained open through the 12-month follow-up period. The Sentinol Nitinol Stent System is comprised of two components: the implantable . Coils, Filters, Stents, and Grafts More. Reproduced with Permission from the GMDN Agency. 2023 Boston Scientific Corporation or its affiliates. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. :V
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_R]O%[D8Y}[1HshY$7\. The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. Find products, medical specialty information, and education opportunities. Fortunately, the devices that exhibited po . THE List - MRI Safety May be removed prior to MRI and replaced after the MRI exam. As the stent is exposed to body temperature it expands to appose the duct wall. Note: If you need help accessing information in different file formats, see
Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. It was launched in the United States in May of 2012. Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. Many of our pacemakers (leadless and traditional), ICDs, ICMs, CRT-Ds, CRT-Ps, pressure sensors, heart valves, occluders and annuloplasty rings are MR Conditional. Once you have completed the checklist, select the Program MRI Settings button to enable MRI Settings. Alternatively, you can also use the latest MRI Manuals to determine scan parameters. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. Boston Scientific Corporation . It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Stents, Drains And Dilators For The Biliary Ducts, Code of Federal Regulations (CFR) Title 21 7.55. Use of these devices may cause serious injuries or death. 86 0 obj
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"Following the recent presentation of our nine-month data, the 12-month ORION data continue to show very strong clinical outcomes," said Dr. Clair. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). Please be sure to read it. The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. Safety of Magnetic Resonance Imaging in Patients With - Circulation AccessGUDID - DEVICE: Ascerta Firm (08714729861720) Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. All other trademarks are the property of their respective owners. Indications for Use The Wallstent Venous Endoprosthesis is indicated for improving central venous diameter . Class 3 Device Recall Sentinol Nitinol Biliary Stent System. To look up your patient's system, use the Product Search tool to determine whether your patient's device and leads (if applicable) are safe for an MRI. Boston Scientific's ELUVIA Drug-Eluting Stent and Coronary Paclitaxel Catalog No. endstream
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Advances in magnetic resonance (MR) imaging and MR angiography over the last 2 decades have led to MR becoming an increasingly attractive imaging modality. Disposable devices associated with implantation may be included. Boston Scientific is recalling the VICI SDS and RDS VENOUS STENT Systems after reports indicate that the stents may migrate or move from where they are initially implanted. Physicians interested in reviewing a complete copy of the revised TAXUS Express2 stent DFU may obtain a copy from the TAXUS website at www.taxus-stent.com. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to see examples of checklist screens and get additional details about the checklist. If a device is not shown in the list, it is not MR Conditional. For more information, please visit: www.bostonscientific.com. There have been 17 complaints and reported injuries related to this issue. No deaths have been reported. PDF 2 7 2 Epic Vascular 2 - Boston Scientific News Releases - Boston Scientific An inner shaft, with two radiopaque markers, aids in the placement of the stent. Epic is a registered or unregistered trademark of Boston Scientific Corporation or its affiliates. C-codesare used for hospital outpatient device reporting for Medicare and some private payers. Epic Vascular Self-Expanding Stent System - Boston Scientific This site is Exclusively Sponsored by BRACCO, ENTERRA THERAPY, Gastric Electrical Stimulation (GES), Neurostimulation System, Orthopedic Implants, Materials, and Devices, Cerebrospinal Fluid (CSF) Shunt Valves and Accessories, Hemostatic Clips, Other Clips, Fasteners, and Staples. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, 12-month Primary Patency by TASC Classification, See all healthcare professional information, Lab Agent - restock products for your practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, Epic Vascular Self-Expanding Stent System, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information, 0 amputations at 3 years (106 subjects), ORION US IDE Clinical Trial to demonstrate similar patency across all TASC classifications, Tandem Architecture Stent Design features Macro, Medium and Micro Struts, as well as patented connector patternsdesigned to optimize flexibility, Hybrid Architecture Design with open- and closed-cell geometry engineered to provide flexibility and deployment uniformity, Macro and Micro Struts are engineered to work in tandem for balanced forceeven in tortuous vasculature, Ergonomic handle with two convenient deployment options: thumb wheel and pull grip, Radiopaque stent markers and catheter shaft marker band enhance visibility and simplify placement, Meticulous surface finishing and polishing to remove imperfections and improve fracture resistance, Tandem Architecture Stent Design engineered to bend and flex and reduce the risk of fracture, 0% Amputation of index limb at 12-months (0/111). PDF Summary of Safety and Effectiveness The trial previously met its primary endpoint of major adverse events (MAE) at nine months with a rate of 3.4 percent for the Epic Stent compared to a pre-specified performance goal. 121 0 obj
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These forward-looking statements include, among other things, statements regarding our business plans, clinical trials and outcomes, our technology, product performance and importance, and competitive offerings. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters.