300 Boston Scientific Way . Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual for additional details about patient monitoring. The FDA has identified this as a Class I recall, the most serious type of recall. Fortunately, the devices that exhibited po . 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 /Subtype /TrueType /Name /F0 /BaseFont /TimesNewRoman /FirstChar 32 /LastChar 255 /Widths [ 250 333 408 500 500 833 778 180 333 333 500 564 250 333 250 278 500 500 500 500 500 500 500 500 500 500 278 278 564 564 564 444 921 722 667 667 722 611 556 722 722 333 389 722 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/Descent -220 /Leading 225 /MaxWidth 1043 /AvgWidth 600 >> endobj 14 0 obj << /Length 15 0 R /Filter /FlateDecode >> stream About Boston ScientificBoston Scientific is a worldwide developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties. Metal Expandable Biliary Stents - Food and Drug Administration You can search by model number or product category. Marlborough, MA 01752-1566 . The positive data support the Boston Scientific goal of delivering products designed to reduce the need for reinterventions and help lower overall healthcare costs. BSC began marketing the product internationally following approval in September 2001. 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. All rights reserved. Note: Boston Scientific is not responsible for the correct use of codes on submitted claims; this informationdoes not constitute reimbursement or legal advice. By using this site, you consent to the placement of our cookies. "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. 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. Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. 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. Boston Scientific's Express 2 (bare-metal) stent system also received approval for immediate MRI exams. Follow the checklist instructions within Merlin PCS Programmer. endstream endobj startxref The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. 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. The Epic Stent should not migrate in this MRI environment. There have been 17 complaints and reported injuries related to this issue. AccessGUDID - DEVICE: Ascerta (08714729802976) May be removed prior to MRI and replaced after the MRI exam. Major adverse events are defined as death within 30 days, myocardial infarction (MI, or heart attack) occurring during hospitalization, target vessel revascularization (TVR) through nine months and amputation of the treated limb through nine months. of Abbott Medical Japan GK. 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. Boston Scientific Corporation Customer Service: 8882721001 www.bostonscientific.com Page 1 of 12 PI86716AG Magnetic Resonance Imaging (MRI) Safety for Boston Scientific Products Table of Contents 1. Safety Topic / Subject Enterra II Model 37800 Gastric Electrical Stimulation (GES) System . Several of these demonstrated magnetic field interactions. The information provided here is not intended to provide information to patients and the general public. CAUTION: These products are intended for use by or under the direction of a physician. AccessGUDID - DEVICE: Ascerta Firm (08714729861720) ALIMAXX-B Biliary Stent Uncovered Biliary Stent Merit Endotek Merit Medical Systems, Inc. South Jordan, UT. Orthopedic Implants, Materials, and Devices More. Class 3 Device Recall Sentinol Nitinol Biliary Stent System. Disposable devices associated with implantation may be included. The Merlin PCS Programmer will print to the default printer (internal printer, external printer or PDF). Refer to the manuals for CardioMEMS HF System or MR Conditional ICMs for details about MRIs with those devices. Interrogate the device with the Merlin PCS Programmer and Aveir Link Module. 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. Refer to the . Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Drummond wire (316L SS) orthopedic implant. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. AccessGUDID - Ascerta Firm (08714729861720)- Ureteral Stent. No amputations were reported through the 12-month period. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. This scientific statement is intended to summarize and clarify issues regarding the safety of MR imaging in patients with cardiovascular devices. f@ (0.89mm) guidewires. Epic Vascular Self-Expanding Stent System - Boston Scientific Sterile. Premarket Approval (PMA) 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. 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. 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. Boston Scientific's ELUVIA Drug-Eluting Stent and Coronary Paclitaxel Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. A Boston Scientific Study of the Epic Self-Expanding Nitonol Stent System in the treatment of Atherosclerotic Lesions in Iliac Arteries 0 amputations at 3 years (106 subjects) 89.9% Freedom from TLR at 3 years (143 lesions) ORION US IDE Clinical Trial to demonstrate similar patency across all TASC classifications AccessGUDID - DEVICE: Ascerta Firm (08714729861775) Boston Scientific, www.bostonscientific.com, Neuroform Atlas Stent Non-clinical testing and analysis have demonstrated that the Neuroform Atlas Stent is MR Conditional alone, or when overlapped with a second stent, and adjacent to a Stryker Neur, AAA Endograft Ovation Ovation Abdominal Stent Graft System TriVascular2, Inc. Santa Rosa, CA, Abre StentMedtronic, Inc., www.Medtronic.com/MRI, Absolute .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, ABSOLUTE 0.35 Biliary Self Expanding Stent System Guidant http://www.guidant.com/ifu/, Absolute Biliary StentAbbott Vascularwww.abbottvascular.com, Absolute Pro .035 Biliary Self-Expanding StentAbbott Vascular, www.abbottvascular.com, Absolute Pro Peripheral Stent Abbott Vascular www.Abbott.com, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 120-mm Single version Abbott Vascular Santa Clara, CA, Absolute Pro Stent Nickel titanium with nickel titanium platinum markers 8-mm x 348-mm three overlapped version Abbott Vascular Santa Clara, CA, ABSOLUTE Biliary Self-Expanding Stent System Nitinol coils, filters, stents Guidant Endovascular Solutions Santa Clara, CA, Absorb Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular, www.abbottvascular.com, Absorb GT1 Bioresorbable Vascular Scaffold (BVS) SystemAbbott Vascular,www.abbottvascular.com, Acculink Carotid StentAbbott Vascularwww.abbottvascular.com, ACCULINK Carotid StentGuidanthttp://www.guidant.com/ifu/, ACS MULTI-LINK Coronary StentAbbott Vascularwww.abbottvascular.com, ACS MULTI-LINK DUET Coronary StentAbbott Vascularwww.abbottvascular.com. Use of these devices may cause serious injuries or death. 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. 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP. Reproduced with Permission from the GMDN Agency. 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. A stent delivery system for a balloon expandable stent consists 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. MR imaging provides excellent spatial . 38948-8607. Abbotts MRI-Ready High Voltage Device Setup for Gallant and Entrant ICD and CRT-Ds (11:45). Before sharing sensitive information, make sure you're on a federal government site. 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.". Read our privacy policy to learn more. 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. You can search by product, model number, category or family. Date of Panel Recommendation: None Premarket Approval Application (PMA) Number: P150003/S058 Date of FDA Notice of Approval: August 10, 2020 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. PDF 2 7 2 Epic Vascular 2 - Boston Scientific 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. Boston Scientific wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, integration of acquired companies, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission. [N-'u,uDQOUyUInFl yO/'wjGs1lx"O88KT9/vjTn ]Y~k\}C ? Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review how data will be handled by each system. Please be sure to read it. This stent has not been evaluated to determine if it is MR Conditional beyond these conditions. MRI Safety for Cardiovascular Products I Abbott Find out who we are, explore careers at the company, and view our financial performance. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 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. 1) Confirm MRI readiness. Indicates a third party trademark, which is property of its respective owner. Coils, Filters, Stents, and Grafts More. DVAz~U|OH_P&xuN)Z6:U<0GI+LQj%]mr2&4SCjyWlQq0H[-2vmu5*Q]zp`MocdS.I>^fp~DEBdo(t Safety Info ID# Safety Topic / Subject Article Text 171: Coils, Filters, Stents, and Grafts: Coils, stents, filters and vascular grafts have been evaluated relative to the use of MR systems. Dont scan the patient if any adverse conditions are present. THE List - MRI Safety Learn the steps for safely preparing Abbotts MRI-Ready GallantTM and EntrantTM High Voltage ICD and CRT-D devices for an MRI scan. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. Use this database for coronary intervention, peripheral intervention and valve repair products. PDF Summary of Safety and Effectiveness Data WALLSTENT with Unistep The results found that the stent was MRI . The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) C-codesare used for hospital outpatient device reporting for Medicare and some private payers. Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com . It is required to program the device to MRI Settings as part of the MRI scan workflow. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. Boston Scientific Promus PREMIER And SYNERGY Drug-Eluting Stent 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. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Conditional 6 More. 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. Download the MRI Ready Systems Manual or MRI Ready Leadless System Manual to review a list of adverse conditions and effects. The default MRI parameter settings are automatically stored in the Abbott MR Conditional device. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. HWnFC=ji6n 9/~\:\$$rxnsU,)Ielo((a,$4bY?W7)MoQEHk1s-;]zXJ$G=0.F4VJYwS|U9VOU@n0ZL26w~+y38.$qW|%-zu'2g:,IwA28nvnP R%ivTpks5>/m5p)H,!HIsqz 9x?pFH=@q}+[|Gd $Xp7lXcV5ZID?vM1V]kM).? Our manuals contain the latest instructions and information for cardiac physicians, radiologists and MR technologists. 0 1.5,3: 1.5,3: Conditional 5 More . 59 0 obj <> endobj PDF Summary of Safety and Effectiveness 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. hbbd``b` C9E tk`/@PHA,HyM! 2023 Boston Scientific Corporation or its affiliates. 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. 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 Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. For more information, please visit: www.bostonscientific.com. Indicates a trademark of the Abbott group of companies. The TAXUS stent system is the first drug-eluting stent to receive approval for immediate post-procedure MRI. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.

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