1. INTRODUCING WATCHMAN How to Setup a Successful Left Atrial Appendage Closure (LAAC) Program SH-303719-AB June 2015

2. Program Agenda A) Institution Evaluation B) Key Players in LAAC Team C) Hospital Support D) Patient Flow E) Patient Selection F) Identify and Educate the Internal and External Referral Pathways G) Market Yourself as a Center of Excellence Backup Tools & Materials SH-303719-AB June 2015

3. A) Institution Evaluation SH-303719-AB June 2015

4. A) Institution Evaluation Your Site Academic or Private LAA Clinical or Commercial EP, IC or Both Structural Heart Program Afib or Complex EP Program Understanding Site -Academic or Private: how to will a LAA program successfully work (similar goals vs. competing goals) -Clinical or Commercial: starting from the ground floor vs. making changes to the existing clinical structure -EP, IC or Both: What specialty is leading the therapy will be key to understanding program administration -Structural Heart Program: Will have a program to learn from (positive & negatives) -Existing AFIB / complex EP program: Understanding of current AFIB patients and their flow SH-303719-AB June 2015

5. A) Institution Evaluation Institutional Qualifications: Minimum requirements (i.e. transseptal experience, TEE, surgical back-up) Access to AF patients/referral network (ability to maintain case volume) EP/IC collaboration (Heart Team): clinical experience demonstrates more successful adoption in accounts Clinical/Implanter Qualifications: Physician skills/experience - transseptal experience, AF ablations, structural heart procedures Transseptal experience - 25 punctures in career, 10 within last 12 months (ASD/PFO not applicable) TEE echocardiography experience / skills Commitment to complete the required WATCHMAN training program Business Qualifications: Ability to commit to initial order – No consignment or rep trunk stock Boston Scientific partnership / collaboration SH-303719-AB June 2015

6. B) Key Players in LAAC Program SH-303719-AB June 2015

7. B) LAAC Team Operators (EP/IC/Echo) Imaging Surgery Dedicated Lab Staff Anesthesiologist Hospital Admin (Marketing, Coding, Finance, data support) Referral Community LAA Coordinator Left Atrial Appendage Team Success Factors in Building a LAAC Team -Collaboration & coordination is key -Coordinator who understands therapy, program and patient flow -Block WATCHMAN Days (anesthesia set time, imaging set time & consistent lab staff) -Hospital and administration support -Education of referral community to understand procedure as well as ensure appropriate patients -Identification of a viable referral base who believes in LAA closure therapy SH-303719-AB June 2015

8. B) LAA Program Key Players -Operator: -Based on operator (EP / IC / Both) will change techniques through out case -LAA Coordinator: -Identify the LAAC Coordinator / Champion that understands the clinical pathway, process and the procedure -Imaging: -Small group of physicians that are trained on views. Consistent measuring pre, during and post. Understand needs for trans septal puncture, standardized protocols, sonographer competency with check off to ensure imaging quality -Anesthesia: -Ability to understand LAA vs TAVR, block time with anesthesia will ensure on time cases -LAAC Lab Staff: -Educated staff on patient needs, procedure and flow will help with outcomes -Surgery: -Establish relationship and understanding of possible back up needs and alt therapies -Referrals Community: -Educated and bought in community that will identify optimal patients for left atrial appendage procedure -Hospital Admin: -Ensure buy in at all administrative levels of the procedure value for patients and hospital / Marketing / PR SH-303719-AB June 2015

9. B) Program Structure Options Structural Heart Complement to existing structural heart program LAAC can complement current structural program including TAVR, Mitral, ASD/PFO Complex EP / Arrhythmia Complement to existing complex left sided EP procedures LAA can complement current complex EP program including extractions, afib and VT ablations Afib Center Complement or new to afib center which manages afib patients and offers all medical and device option to patients LAAC can be another offering to your afib patients that suffer from a variety of oral anticoagulation side effects LAA Program Offer a full suite of LAA closure options which include surgical and noninvasive LAAC can be another offering to current surgery options offered to patients Operators: IC and EP with the support of Echo Coordinator: Supports operators in all program structures SH-303719-AB June 2015

10. C) Hospital Support SH-303719-AB June 2015

11. C) Hospital Support Additional Key Players in Hospital Administration Administration: CEO, Directors, Department Chair Economics: Finance-Billing/Coding Team Lab Leaders:CV Service Line Directors Material Mgt:Purchasing, Inventory, etc Marketing Team:Strategic Planning and Marketing SH-303719-AB June 2015

12. C) Hospital Support 1 st Step to Building Successful LAAC Program Gain hospital support on all levels Establish and educate on clinical need for program Discuss patient benefit –Improve patient outcomes compared to oral anticoagulation –Reduce oral anticoagulation burden on your patients’ QOL Discuss Hospital and Program Advantage –Marketing differentiator –Physician retention and recruitment –Comprehensive AF/Stroke treatment program Hospital Opportunity –Incremental patient growth SH-303719-AB June 2015

13. C) Hospital Support Key Points Coverage gaps are routine for new novel technologies (e.g., SAPIEN, MitraClip) BSC is proactively working with CMS and FDA with the goal of facilitating Medicare coverage as soon as possible after FDA approval If coverage is not in place upon FDA approval, it will be necessary for clinicians/hospitals to seek coverage on a case-by-case basis by appealing denials if they occur IN-PATIENT ONLY procedure and anticipate patient population to be primarily Medicare. Not subject to the two midnight rule. “Reimbursement” = Coding + Coverage + Payment Rates Upon FDA approval, we will have Coding and Payment Rates established. Will apply for Coverage when eligible… immediately after approval. SH-303719-AB June 2015

14. Hospital Reimbursement: Will I get paid? SH-303719-AB June 2015

15. Implanting Physician Reimbursement: Will I get paid? SH-303719-AB June 2015

16. C) Hospital Support Tools Available Download Central (click above) WATCHMAN Comprehensive Reimbursement (coding, coverage, and payment) Guide WATCHMAN Prior Authorization template WATCHMAN Appeals template WATCHMAN Economic Value Presentation (via Economic Navigator web tool) Physician Category III Code Guide Documentation & MS-DRG Guide Hospital Appropriateness of Charging Guide WATCHMAN Value Toolkit Health economic and reimbursement information provided by Boston Scientific Corporation is gathered from third-party sources and is subject to change without notice as a result of complex and frequently changing laws, regulations, rules and policies. This information is presented for illustrative purposes only and does not constitute reimbursement or legal advice. Boston Scientific encourages providers to submit accurate and appropriate claims for services. It is always the provider’s responsibility to determine medical necessity, the proper site for delivery of any services and to submit appropriate codes, charges and modifiers for services that are rendered. Boston Scientific recommends that you consult with your payers, reimbursement specialists and/or legal counsel regarding coding, coverage and reimbursement matters. Boston Scientific does not promote the use of its products outside their FDA-approved labeling. Payer policies will vary and should be verified prior to treatment for limitations on diagnosis, coding or site of service requirements. The coding options listed within this guide are commonly used codes and are not intended to be an all-inclusive list. Providers are responsible for making appropriate decisions related to coding and reimbursement submissions. We recommend consulting your relevant manuals for appropriate coding options. Payer policies will vary and should be verified prior to treatment for limitations on diagnosis, coding or site of service requirements. The coding options listed within this guide are commonly used codes and are not intended to be an all-inclusive list. We recommend consulting your relevant manuals for appropriate coding options. SH-303719-AB June 2015

17. C) Hospital Support Other Efforts to be Coordinated (if applicable): Quality Team –Ensure understanding of WATCHMAN product and support from quality team Value Analysis Team Meeting –Secure date and meeting time for WATCHMAN product LAAC Credentials –Define credentials are in place at time of launch Reimbursement & Economics –Support of WATCHMAN procedure reimbursement process (resources available) Data Support –Ability to support tracking and collecting data for study, registry and additional procedures performed on LAAC patients SH-303719-AB June 2015

18. D) Patient Flow through LAAC Procedure SH-303719-AB June 2015

19. D) Patient Flow through LAAC Procedure Education Educate patients and families about disease and treatment options Educate on the LAAC procedure Explanation of risks and benefits of procedure Explanation of the process from screening >> procedure >> follow up Screening Secure insurance pre-authorization for procedure Ensure patient is appropriate candidate for LAAC procedure (indication)/supporting documentation Review previous TEE (if available) or schedule new TEE to ensure patient in a good candidate (size, thrombus, etc.) Scheduling Schedule pre-procedure diagnostic studies, labs, echo, etc. Schedule procedure date for lab time, implanter, anesthesia, TEE physician, patient, company representative (LAAC team) Schedule post-procedure follow-up office visit, labs and TEE @ time of discharge (if registry req) Procedure Ensure patient has followed pre procedure instructions Ensure all key players in the LAAC team are present for procedure Post procedure ensure that patient and family understand post procedure instructions (medication, follow up TEE date, etc.) SH-303719-AB June 2015

20. D) Patient Flow through LAAC Procedure Patient Education 1)Disease State 2)Disease Treatment (drug vs. device) 3)Procedure 4)Risks & Benefits 5)Procedure Process Tools Available Download Central (click above) -Patient Material -Patient Brochure -Patient video / animation -Device example Additional Materials -WATCHMAN Patient Website clickclick -Post Implant FAQ -Pre and Post Procedure samples -Website(s) -StopAfib.org clickclick SH-303719-AB June 2015

21. D) Patient Flow through LAAC Procedure Patient Screening 1)Ensure patient is appropriate candidate for LAAC procedure 2)Secure insurance pre-authorization for procedure 3)Review previous TEE (if available) OR schedule new TEE (Views, size, thrombus) Screening Tools Available -Download Central (click above) -Indication Material -Echo protocols (view, size, thrombus) Patient Identification Tools -EMR queries / workflow -Patient database / worksheet -LAAC Patient Sources (Coumadin clinics, GI clinic, ER) SH-303719-AB June 2015

22. C) Patient Flow through LAAC Procedure Pre-procedural Instructions (found in DFU) A baseline TEE should be performed to verify that a patient’s anatomy is appropriate for a WATCHMAN® Device to be implanted. 1. Assess the following through multiple imaging planes (0°, 45°, 90° and 135° sweep): -LAA size/shape, number of lobes in LAA, and location of lobes relative to the ostium. -Confirm the absence of thrombus (use Color Doppler and echo contrast as necessary). 2. Record LAA ostium and LAA length measurements (0°, 45°, 90° and 135° sweep). Measure the LAA ostium at approximately these angles: -at 0° measure from coronary artery marker to a point 2 cm from tip of the “limbus” -at 45° measure from top of the mitral valve annulus to point 2 cm from tip of the “limbus” -at 90° measure from top of the mitral valve annulus to a point 2 cm from tip of the “limbus” -at 135° measure from top of the mitral valve annulus to a point 2 cm from tip of the “limbus” Measured maximum LAA ostium width must be ≥17 mm or ≤31mm to accommodate available device size SH-303719-AB June 2015

23. D) Patient Flow through LAAC Procedure Scheduling Patients 1)Schedule pre-procedure diagnostic studies, labs, echo, etc. 2)Schedule procedure date (LAA day) for lab time, implanter, anesthesia, TEE physician, patient, company representative (LAAC team) 3)Ensure discharge protocol is understood prior to procedure and re-iterated at discharge 4)Schedule post-procedure follow-up office visit, labs and TEE Scheduling Tools / Best Practices Dedicated LAA days (operator, anesthesia, echo, lab staff) Ensure ample inventory and supplies WATCHMAN Checklist Ensure patient understands pre and post procedure expectations Standard Discharge worksheet SH-303719-AB June 2015

24. D) Patient Flow through LAAC Procedure Pre Procedure Procedure Post Procedure SH-303719-AB June 2015

25. D) Patient Flow through LAAC Procedure Pre-Procedural Screening -Understanding the indication and patient selection is key -Ensure patient qualifies for a WATCHMAN -Imaging requirements (size, thrombus, etc) -Educate patient and family on procedure -Consent patient Pre-Procedural Screening Tools / Best Practice -Download Central (click above) -Patient Education Material -Sample Documents (WATCHMAN homework and Information Sheet) SH-303719-AB June 2015

26. D) Patient Flow through LAAC Procedure Procedure Understanding Download Central (click above) Procedure explanation & video (click above) Understanding of Potential Complications Pericardial Effusion Device Migration Peri-Procedural CVA Assess complication SH-303719-AB June 2015

27. D) Patient Flow through LAAC Procedure Post Procedure -Patient Post Procedure -Hospital Stay -1 night overnight (in most cases) -Follow Up Office Visits -Follow Up Office visit 7 – 10 post procedure (or your protocol) -TEE Follow Up at 45 days -Drug Regimen -Recommended (next page) -Coordinator / Hospital Post Procedure -Data collection for internal database/required registry -Discharge Instructions completed by NP / Physician -Follow up and TEE scheduled -Update Referral MD on procedure and patient outcome SH-303719-AB June 2015

28. C) Patient Flow through LAAC Procedure Post-Procedural Information (found in DFU) 1. Post-procedure warfarin therapy is required in ALL patients receiving a WATCHMAN Device. Patients should remain on 81-100 mg of aspirin and warfarin should be taken post-implant (INR 2.0-3.0). At 45 days (±15 days) post-implant, perform WATCHMAN Device assessment with TEE. Cessation of warfarin is at physician discretion provided that any peri-device flow demonstrated by TEE is ≤5 mm. If adequate seal is not demonstrated, subsequent warfarin cessation decisions are contingent on demonstrating flow ≤5 mm. At the time the patient ceases warfarin, the patient should begin clopidogrel 75 mg daily and increase aspirin dosage to 300-325 mg daily. This regimen should continue until 6 months have elapsed after implantation. Patients should then remain on aspirin 300-325 mg indefinitely. If a patient remains on warfarin and aspirin 81-100 mg for at least 6 months after implantation, and then ceases warfarin, the patient should not require clopidogrel, but should increase to aspirin 300-325 mg daily, which should be taken indefinitely. 2. At 45 days and 12 months: assess WATCHMAN Device with TEE. -Confirm absence of intra-cardiac thrombus. -Perform color Doppler assessment to include the device/LAA border at the following approximate TEE angles (0°, 45°, 90° and 135°). Measure any residual leak around the device if necessary. -If thrombus is observed on the device, warfarin therapy is recommended until resolution of thrombus is demonstrated by TEE. 3. Prescribe appropriate endocarditis prophylaxis for 6 months following device implantation. The decision to continue endocarditis prophylaxis beyond 6 months is at physician discretion SH-303719-AB June 2015

29. C) Patient Flow through LAAC Procedure SH-303719-AB June 2015

30. E) Patient Selection SH-303719-AB June 2015

31. E) Patient Selection INDICATIONS FOR USE The WATCHMAN Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who: –Are at increased risk for stroke and systemic embolism based on CHADS 2 or CHA 2 DS 2 -VASc [1] scores and are recommended for anticoagulation therapy; [1] –Are deemed by their physicians to be suitable for warfarin; and –Have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin SH-303719-AB June 2015

32. E) Patient Selection PATIENT SELECTION FOR TREATMENT Selection among available treatment options must first take into account whether anticoagulation is indicated to reduce the risk of stroke based on CHADS2 or CHA2DS2-VASc scores. Next, in a patient who is deemed by their physicians to be suitable for anticoagulation with warfarin, physicians and patients should consider the rationale for implantation of the WATCHMAN Device as an alternative to long-term warfarin therapy. Specific factors may include one or more of the following: – A history of major bleeding while taking therapeutic anticoagulation therapy. –The patient’s prior experience with oral anticoagulation (if applicable), which may include an inability to maintain a stable therapeutic International Normalized Ratio (INR) or inability to comply with regular INR monitoring AND unavailability of an approved alternative anticoagulation agent. –A medical condition, occupation, or lifestyle placing the patient at high risk of major bleeding secondary to trauma. Some studies of patients with a history of falls, or at risk for falls and head trauma, have shown that the benefits of anticoagulation therapy to reduce the risk of stroke outweigh the risk of major, life-threatening bleeding. An individualized benefit and risk assessment should be made in such patients.3, 4, 5 –The presence of indication(s) for long-term warfarin use, other than non-valvular atrial fibrillation (e.g. mechanical heart valve, hypercoagulable states, recurrent deep venous thrombosis). Specific factors that need to be considered for the WATCHMAN Device and implantation procedure include the following: –Overall medical status, including conditions which might preclude the safety of a percutaneous, transcatheter procedure. –Suitability for percutaneous, trans-septal procedures, including considerations of: Cardiac anatomy relating to the LAA size and shape. Vascular access anatomy (e.g., femoral vein size, thrombus, or tortuosity.) Ability of the patient to tolerate general or local anesthesia. Ability of the patient to undergo required imaging. –Ability to comply with the recommended post-WATCHMAN Device implant pharmacologic regimen, especially for patients at high risk for bleeding, i.e., the need for warfarin plus aspirin for at least 45 days post-device implantation, clopidogrel and aspirin through 6 months post-procedure, and aspirin indefinitely. SH-303719-AB June 2015

33. E) Patient Selection Patients with high risk for ischemic events Patients with high risk for bleeding events Patients with reasonable anatomy and access Patient must be a candidate for long-term anticoagulation Reasonably high risk enough for the patient to notice or comprehend the complications of anticoagulation SH-303719-AB June 2015

34. F) Identify and Educate the Internal and External Referral Pathways SH-303719-AB June 2015

35. Referral Patterns Private practice (GC, GP, Geriatrics…) Patients External Referring centers (EP, IC, cards, Neuro, GI, ER) Inside the hospital (EP, IC, clin cards, Neuro, GI, ER) Within implanter’s practice SH-303719-AB June 2015

36. Steps to Building Awareness Begin Plan your referral strategy and educate your business partners Act Publicize through local media and build your referral base Share Accelerate adoption by deepening referring physician understanding Educate Guide patient flow through education SH-303719-AB June 2015

37. F) Identify and Educate the Internal and External Referral Pathways Locate with Atrial Fibrillation LAA Program Direct Referral Primary Cardiologist Primary Care Provider Coumadin Clinic Stroke Team Non Invasive/EP SH-303719-AB June 2015

38. F) Identify and Educate the Internal and External Referral Pathways Identify Internal & External Referral Pathways Educate Internal & External Referral Pathways InternalExternal -Clinic (current patients) -Afib Clinic (internal) + Coumadin clinic -Cardiologist -AHPs -Geriataric -ER / hospitalist (onset or AFIB / stroke) -EMR Data query (existing patients) -TEE Screening -GI -Neurologist -Current external referrals (cardiologist, GPs, GI, Neurologist, etc) -New referrals due to exclusive technology InternalExternal -Grand rounds -Lunch & Learns -Morning conference -Marketing team (website, newsletter to internal employees) -Marketing team (News, media & print to external stakeholders) -Dinner engagements -Local society meeting SH-303719-AB June 2015

39. F) Identify and Educate the Internal and External Referral Pathways Referral to Treatment Timeline 48-72 hours Patient/MD contacted Records/pre- auth initiated 7 days Consult with TTE/TEE Additional workup (Baseline additional customary pre-procedure testing) 10 days Presented w/treatment plan in place Research if appropriate Scheduled for pre-procedure visit Within 14-28 days Patient is treated SH-303719-AB June 2015

40. F) Identify and Educate the Internal and External Referral Pathways Referral Education and Materials -Download Central (click above) -Education Tools: -WATCHMAN Device Overview and WATCHMAN Economic Value Proposition -Media Kit Tools: -Hospital Press Release, Hospital Newsletter, Video, Images and Product messaging -Tools to Engage Referring Physicians -Email Blast Template, Letter of Introduction, Education Event Invite, Education Event Thank You letter -Additional Tools -Therapy Awareness Toolkit (hard copy & electronic) -Implanters step-by-step instruction & easily accessible tools for how to drive awareness for their WATCHMAN program with their referring physicians. SH-303719-AB June 2015

41. G) Market Yourself as a Center of Excellence SH-303719-AB June 2015

42. Potential Marketing Opportunities Use the WATCHMAN™ Device as a proof point for why referring physicians and their patients should seek out care at your institution by incorporating the WATCHMAN Device into: Hospital website/newsletter Newsletters for referring physicians Social media outlets Identify a patient who was enrolled in the clinical study who would be willing to share their story Consider inviting local media to your institution to coincide with an implant Use a patient story you may have identified Interview the implanting physician Issue hospital press release Engage hospital switchboard so they know who to direct patients to when asked about stroke/WATCHMAN Device The WATCHMAN™ LAA Closure Device is CE Marked and is currently available For Investigational Use Only in the United States. Not for sale in the United States. SH-303719-AB June 2015

43. Hospital Marketing Resources Hospital Press Release Template Product Messaging Guide Hospital Newsletter Template Product Images (.jpg files) Implant animation video Patient Brochure Patient Website Patient Testimonials *** Link to Resources **** The WATCHMAN™ LAA Closure Device is CE Marked and is currently available For Investigational Use Only in the United States. Not for sale in the United States. SH-303719-AB June 2015

44. Starting a left atrial appendage program takes a dedicate team to support patient flow, LAAC cases and new patients Appropriate and optimal patient selection is key to success Education at all levels of the hospital: administration, operators, coordinator, lab, anesthesia, cv surgery, referral community is key to long term program success Build and educate referral pathways to ensure patient flow Summary: SH-303719-AB June 2015

45. ABBREVIATED STATEMENT WATCHMAN TM Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Access System INDICATIONS FOR USE The WATCHMAN Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation who: Are at increased risk for stroke and systemic embolism based on CHADS 2 or CHA 2 DS 2 -VASc scores and are recommended for anticoagulation therapy; Are deemed by their physicians to be suitable for warfarin; and Have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin. The WATCHMAN Access System is intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems. CONTRAINDICATIONS Do not use the WATCHMAN Device if: Intracardiac thrombus is visualized by echocardiographic imaging. An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present. The LAA anatomy will not accommodate a device. See Table 46 in the DFU. Any of the customary contraindications for other percutaneous catheterization procedures (e.g., patient size too small to accommodate TEE probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present. There are contraindications to the use of warfarin, aspirin, or clopidogrel. The patient has a known hypersensitivity to any portion of the device material or the individual components (see Device Description section) such that the use of the WATCHMAN Device is contraindicated. WARNINGS Device selection should be based on accurate LAA measurements obtained using fluoro and ultrasound guidance (TEE recommended) in multiple angles (e.g., 0º, 45º, 90º, 135º). Do not release the WATCHMAN Device from the core wire if the device does not meet all release criteria. If thrombus is observed on the device, warfarin therapy is recommended until resolution of thrombus is demonstrated by TEE. The potential for device embolization exists with cardioversion <30 days following device implantation. Verify device position post-cardioversion during this period. Administer appropriate endocarditis prophylaxis for 6 months following device implantation. The decision to continue endocarditis prophylaxis beyond 6 months is at physician discretion. For single use only. Do not reuse, reprocess, or resterilize. PRECAUTIONS The safety and effectiveness (and benefit-risk profile) of the WATCHMAN Device has not been established in patients for whom long-term anticoagulation is determined to be contraindicated. The LAA is a thin-walled structure. Use caution when accessing the LAA and deploying the device. Use caution when introducing the WATCHMAN Access System to prevent damage to cardiac structures. Use caution when introducing the Delivery System to prevent damage to cardiac structures. To prevent damage to the Delivery Catheter or device, do not allow the WATCHMAN Device to protrude beyond the distal tip of the Delivery Catheter when inserting the Delivery System into the Access Sheath. If using a power injector, the maximum pressure should not exceed 100 psi. In view of the concerns that were raised by the RE-ALIGN 1 study of dabigatran in the presence of prosthetic mechanical heart valves, caution should be used when prescribing oral anticoagulants other than warfarin in patients treated with the WATCHMAN Device. The WATCHMAN Device has only been evaluated with the use of warfarin post-device implantation. ADVERSE EVENTS Potential adverse events (in alphabetical order) which may be associated with the use of a left atrial appendage closure device or implantation procedure include but are not limited to: Air embolism, Airway trauma, Allergic reaction to contrast media/medications or device materials, Altered mental status, Anemia requiring transfusion, Anesthesia risks, Angina, Anoxic encephalopathy, Arrhythmias, Atrial septal defect, AV fistula, Bruising, hematoma or seroma, Cardiac perforation, Chest pain/discomfort, Confusion post procedure, Congestive heart failure, Contrast related nephropathy, Cranial bleed, Decreased hemoglobin, Deep vein thrombosis, Death, Device embolism, Device fracture, Device thrombosis, Edema, Excessive bleeding, Fever, Groin pain, Groin puncture bleed, Hematuria, Hemoptysis, Hypotension, Hypoxia, Improper wound healing, Inability to reposition, recapture, or retrieve the device, Infection / pneumonia, Interatrial septum thrombus, Intratracheal bleeding, Major bleeding requiring transfusion, Misplacement of the device / improper seal of the appendage / movement of device from appendage wall, Myocardia erosion, Nausea, Oral bleeding, Pericardial effusion / tamponade, Pleural effusion, Prolonged bleeding from a laceration, Pseudoaneurysm, Pulmonary edema, Renal failure, Respiratory insufficiency / failure, Surgical removal of the device, Stroke – Ischemic, Stroke – Hemorrhagic, Systemic embolism, TEE complications (throat pain, bleeding, esophageal trauma), Thrombocytopenia, Thrombosis, Transient ischemic attack (TIA), Valvular damage, Vasovagal reactions There may be other potential adverse events that are unforeseen at this time. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. © 2015 Boston Scientific Corporation or its affiliates. All rights reserved. 1 Eikelboom JW, Connolly SJ, Brueckmann M, et al. N Engl J Med 2013;369:1206-14. SH-303719-AB June 2015