Class 3 Device Recall Sentinol Nitinol Biliary Stent System. The stent is constrained within a 6F delivery system. Catalog No. (,OcEh{[%E#Xl@::9(k]xv# q#fs+[Jb{-$r;EB9 pdRkEdq^(PFG3|'ae1wsv4N5:YBswO[kQC9U0EJ[Tkd/*4s3_SN}W~jj,SPuT-9 )44ZtGtWAO@Fo aP3lqS-P*)v"rj5QEWL!zg8KbORyvm?B'tZ&3D#>7"7Q8&a*$"xmVTeV [@[@.o)BpiyHpV1FIh\w|wD!2N^# U#gb a]qkz,'@Ri3 Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. 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. From the FastPath Summary screen, select the Print button to print the Diagnostics and any other relevant reports. epic vascular self-expanding stent system: Boston Scientific Corp. P110035 S045: 04/03/2018: memorygel silicone gel-filled breast implants: MENTOR CORP. P030053 S045: 01/30/2018: reflection ceramic acetabular hip system: Smith & Nephew, Inc. P030022 S045: 121 0 obj <>stream Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. 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. We recommend that you download and review the most current version any time a patient with an Abbott product needs an MRI. Data from the first human use NG PROMUS Clinical Trial evaluating the safety and effectiveness of the Promus PREMIER Everolimus-Eluting . This site is Exclusively Sponsored by BRACCO. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. 5-year data for. The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. Find out who we are, explore careers at the company, and view our financial performance. :V m_C.4c9M/:4"Pp^8r_h_(2KDz]H4{T["y&7xPWe8Iw]rp%c2D|t-++@n 6j.#C\Ks _R]O%[D8Y}[1HshY$7\. Dont scan the patient if any adverse conditions are present. Patients experienced significant clinical improvement from baseline to twelve months based on feedback from validated questionnaires evaluating walking distance, speed and stair climbing. Marlborough, MA 01752-1566 . 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. C-codesare used for hospital outpatient device reporting for Medicare and some private payers. You can search by model number or product category. Patients receiving coronary stents have typically been required to wait approximately two months before receiving an MRI. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. endstream endobj 60 0 obj <>>>/Filter/Standard/Length 128/O(v~aIgInj rM)/P -1340/R 4/StmF/StdCF/StrF/StdCF/U( ey,62_ )/V 4>> endobj 61 0 obj <>>> endobj 62 0 obj <> endobj 63 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text]/Properties<>/Shading<>/XObject<>>>/Rotate 0/TrimBox[24.0 24.0 619.276 865.89]/Type/Page>> endobj 64 0 obj <>stream GMDN Names and Definitions: Copyright GMDN Agency 2015. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . }7MWJ!%c. 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 [?] Proper patient monitoring must be provided during the MRI scan. Several of these demonstrated magnetic field interactions. ,TFZ3R?ZU,6P;0rY;qC\#*"zgZ71j:clLv^O LHf,xvU8pZ7 9^FHZ|+iL V~G!=}6. 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. The site is secure. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. BSC began marketing the product internationally following approval in September 2001. An official website of the United States government, : The delivery system is compatible with 0.035 in. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for details on default settings and how to save modified settings for scanning. Introduction II. Paul, M, Esophageal Reconstruction TubeHood Laboratories, www.hoodlabs.com, Esophageal Stent, Niti-S & Comvi Model E2423TaeWoong Medical Co., Ltd., www.stent.net, Esophageal StentHood Laboratories, www.hoodlabs.com, Esophageal TTS StentTaeWoong Medical Co., Ltd., www.stent.net, Esophagus Full-Covered StentCG BIO CO., LTD. www.cgbio.co.kr/en/. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). It may be a continuous tube or a mesh structure in tubular form and is available in a variety of lengths and diameters. Search for arrhythmia, heart failure and structural heart IFUs. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . The product, pouch label and carton label are all correct and the correct DFU is in the package. Upon approval, the Epic Stent along with the market-leading Express LD balloon-expandable iliac stent, would enable Boston Scientific to offer a complete line of advanced iliac solutions for physicians and patients." The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The MAE rate at 12 months was 5.4 percent, with all MAEs related to TVR. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) Our manuals contain the latest instructions and information for cardiac physicians, radiologists and MR technologists. All rights reserved. hbbd``b` C9E tk`/@PHA,HyM! 38948-8607. 2*Uax?t} Boston Scientific 2 Agenda I. Please be sure to read it. Alternatively, you can also use the latest MRI Manuals to determine scan parameters. 1) Confirm MRI readiness. Furthermore, outcomes for very complex (TASC C/D) lesions were similar to those reported for less complex (TASC A/B) lesions. f@ Overview of the ELUVIA Drug- Eluting Stent (DES) III. You can search by product, model number, category or family. Magnetic Resonance MR Conditional 3.0 tesla temperature information Instructions for Downloading Viewers and Players, Class 3 Device Recall Sentinol Nitinol Biliary Stent System. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes . This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. of Abbott Medical Japan GK. 1.5,3: Safety Topic / Subject ALIMAXX-B Uncovered Biliary Stent 10-mm x 80-mm . Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. Coronary data supports safety of paclitaxel and ELUVIA DES IV. Use this database for coronary intervention, peripheral intervention and valve repair products. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. MRI safety testing has shown that the REBEL Stent is MR Conditional and that Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the ORION trial and chairman of the Department of Vascular Surgery at The Cleveland Clinic Foundation, at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. The ORION clinical data was used to support application for U.S. Food and Drug Administration approval of the Epic Stent System. 7th.Ine!Y+mOTqDm/`*XBagB8GzXov8P1zluIz y "0!rab/dMwLtX1@_18TUWW\ T/~dc/mRE 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. This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Before sharing sensitive information, make sure you're on a federal government site. A migrated stent may require another surgery or catheter procedure to retrieve it, which increases risks to the patient, including possible damage to the blood vessel, heart walls or other organs. 2022 Boston Scientific Corporation or its affiliates. Boston Scientific performed rigorous laboratory testing to demonstrate MRI compatibility. Illustrations are artist's representations only and should not be considered as engineering drawings or photographs. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. No amputations were reported through the 12-month period. 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 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. About Epic and the ORION Trial The Epic Stent is a self-expanding nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. Results were presented today by Daniel Clair, M.D., FACS, principal investigator of the . 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. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and may be inserted with a balloon catheter which causes the device to expand when inflated, or it may self-expand after insertion with a delivery device. 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. Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. "The positive 12-month data from the ORION trial complement our early launch success and market share gains," said Jeff Mirviss, president of Peripheral Interventions at Boston Scientific. endstream endobj startxref For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. 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. Fortunately, the devices that exhibited po, 2D Helical, 35 Fibered Platinum Coil. 3: Conditional 6 . "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. Find products, medical specialty information, and education opportunities. Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. Indicates a trademark of the Abbott group of companies. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. 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.". 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). A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. Use this database for arrhythmia, heart failure and structural heart products. This site uses cookies. 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. The prospective, single-arm ORION trial enrolled 125 patients at 28 sites in the United States. Newmatic Medical, www.newmaticmedical.com. (0.89mm) guidewires. "The Epic Stent has been very well-received by physicians across the country. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. 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. 1 0 obj << /Creator (Venous Wallstent SSED vers 2 - Microsoft Word) /CreationDate (D:20020508130644Z) /Title (P980033) /Author (Author: ODE) /Producer (Acrobat PDFWriter 5.0 for Windows NT) /Subject (Issue: 11-16-2001) /Keywords (Posted: 05-08-2002) /ModDate (D:20020508134926-03'00') >> endobj 2 0 obj [ /PDF /Text ] endobj 3 0 obj << /Pages 60 0 R /Type /Catalog /Metadata 87 0 R >> endobj 4 0 obj << /Type /Page /Parent 5 0 R /Resources << /Font << /F0 6 0 R /F1 8 0 R /F2 10 0 R /F3 12 0 R >> /ProcSet 2 0 R >> /Contents 14 0 R /Thumb 65 0 R >> endobj 5 0 obj << /Kids [ 4 0 R 16 0 R 21 0 R 27 0 R 30 0 R 36 0 R ] /Count 6 /Type /Pages /Parent 60 0 R >> endobj 6 0 obj << /Type /Font 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IFbj.)D^7TE.V\Bz->/. {}(;]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 #>of=eP V}-St:Ur{>J;{n=b^mZ? The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. 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. 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. Fortunately, the devices that exhibited po . Boston Scientific Corporation . %PDF-1.5 % The FDA has identified this as a Class I recall, the most serious type of recall. Based on the country you select, you can choose the device and lead combination (if applicable) to get scan parameters. 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). Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. For more information, please visit: www.bostonscientific.com. "The Epic Stent is a novel stent platform designed to offer both acute and clinical advantages over older-generation stent systems. All rights reserved. AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. All other trademarks are the property of their respective owners. H7YPnf'Sq-. 2022 Boston Scientific Corporation or its affiliates. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. No deaths have been reported. 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). The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Esophageal Stent, Niti-S & Comvi Model E2423 TaeWoong Medical Co., Ltd., www.stent.net. Company Name: BOSTON SCIENTIFIC CORPORATION Primary DI Number: 08714729861775 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 [?] For more information, please visit: www.bostonscientific.com. NOTE: Device diagnostic data may be suspended or cleared when MRI Settings are enabled. Testing, Training, and Books 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.

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