WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

Report

• Report Number: 2124215-2025-90604
• Event Type: Injury
• Date Received: December 12, 2025
• Report Date: December 12, 2025
• Manufacturer: BOSTON SCIENTIFIC CORPORATION
• Product Code: NGV
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

TIME FRAME OF EVENT DATE COLLECTION: PATIENTS IN TRUVETA HEALTH SYSTEMS IMPLANTED WITH WATCHMAN FLX DEVICE BETWEEN JANUARY 2020 AND OCTOBER 2024. SUMMARY OF ADVERSE EVENTS: THE ANALYSIS REPORTS ON A PROPENSITY-SCORE MATCHED COHORT TO ASSESS OUTCOMES IN PATIENTS WITH A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE COMPARED TO THOSE RECEIVING NON-VITAMIN K ANTAGONIST ORAL ANTICOAGULANTS (NOAC). THE EVALUATION INCLUDES 90-DAY EVENT RATES FOR WATCHMAN FLX PRO AND 3-YEAR EVENT RATES FOR WATCHMAN FLX. REPORTED OUTCOMES ENCOMPASS THE FOLLOWING: PRIMARY ENDPOINT 1 (STROKE, DEATH, AND SYSTEMIC EMBOLISM), PRIMARY ENDPOINT 2 (NON-PROCEDURAL BLEEDING), ISCHEMIC STROKE, SYSTEMIC EMBOLISM, AND ALL-CAUSE MORTALITY. TOTAL NUMBER OF PATIENTS: 6397 DEVICE EVALUATION: UNDER THE TERMS AND CONDITIONS OF THE STUDY, ANONYMIZED DATA WAS PROVIDED. NO PRODUCTS WERE RETURNED AS PART OF THE STUDY. IT CANNOT BE DETERMINED IF THESE EVENTS HAVE BEEN PREVIOUSLY REPORTED OR IF THE DEVICES WERE RETURNED FOR ANALYSIS AS PART OF A PREVIOUSLY REPORTED SPONTANEOUS COMPLAINT. HOWEVER, THE EVENTS REPORTED WERE ANTICIPATED IN NATURE AS DEFINED BY THE "POTENTIAL ADVERSE EVENTS" LIST IN THE FDA-APPROVED INSTRUCTIONS FOR USE (IFU). CONTEXTUAL ANALYSIS OF STUDY DATA: OVERALL, THE 3-YEAR OUTCOMES AFTER WATCHMAN FLX IMPLANT AND 90-DAY OUTCOMES AFTER WATCHMAN FLX PRO IMPLANT THAT WERE FOUND DURING THIS ANALYSIS OF THE TRUVETA DATABASE ALIGN WITH WHAT IS EXPECTED BASED ON PUBLISHED LITERATURE. THE 3-YEAR INDIVIDUAL EVENT RATES REPORTED IN THIS ANALYSIS FOR WATCHMAN FLX FOR DEATH (12.8%), ISCHEMIC STROKE (3.8%), AND SYSTEMIC EMBOLISM (0.29%) FALL WITHIN OR BELOW EXPECTED RANGES. ALTHOUGH 3-YEAR PUBLISHED RATES FROM SIMILAR REGISTRY-BASED ANALYSES IN THE UNITED STATES ARE LIMITED, A MEDICARE-BASED ANALYSIS REPORTED A 44.2% MORTALITY RATE AT 5 YEARS WITH AN ESTIMATED 8-10% ANNUAL RATE, LEADING TOWARD AN ESTIMATED 3-YEAR RATE OF 24.0%-30.0%.1 THIS PUBLICATION ALSO FOUND AN ESTIMATED 1.0%-1.5% ANNUAL RATE OF ISCHEMIC STROKE (6.6% AT 5 YEARS; 3.0%-4.5% AT 3 YEARS)(1). A SIMILAR MEDICARE-BASED ANALYSIS SUPPORTS THESE RESULTS WITH KEY FINDINGS OF AN ESTIMATED 3-YEAR ISCHEMIC STROKE RATE OF 3.5%, AND A MORTALITY RATE NEAR 27% (2). A RANDOMIZED TRIAL WITH A SIMILAR GOAL OF COMPARING LAAC AND OACS OBSERVED A 15.6% RATE FOR ALL-CAUSE DEATH AT 3 YEARS (3) AND RECENT RANDOMIZED TRIAL LOOKING SPECIFICALLY AT WATCHMAN DEVICES REPORTED 3-YEAR RATES OF 29.0% FOR DEATH, 7.2% FOR ISCHEMIC STROKE, AND 2.2% FOR SYSTEMIC EMBOLISM (4). THE 90-DAY INDIVIDUAL EVENT RATES REPORTED IN THIS ANALYSIS FOR WATCHMAN FLX PRO FOR DEATH (0.56%), ISCHEMIC STROKE (1.11%), AND SYSTEMIC EMBOLISM (0.25%) ALSO FALL WITHIN EXPECTED RANGES. ALTHOUGH 90-DAY EVENT RATES ARE RARELY REPORTED, THE RATES FOUND IN THIS ANALYSIS FROM THE TRUVETA DATABASE FALL BELOW OR BETWEEN REPORTED 45-DAY AND 1-YEAR RATES. IN PUBLICATIONS FROM A NATIONWIDE REGISTRY, RATES OF ALL-CAUSE DEATH RANGED FROM 0.81% AT 45 DAYS TO 8.2%(5) AND 8.5%(6) AT 1 YEAR, ISCHEMIC STROKE RANGED FROM 0.23%(5) AT 45 DAYS TO 1.2%(5) AND 1.5%(6) AT 1 YEAR, AND SYSTEMIC EMBOLISM RANGED FROM 0.01%(5) AT 45 DAYS TO 0.68%(6) AT 1 YEAR. THUS, ALL 3-YEAR AND 90-DAY RATES FOUND IN THIS ANALYSIS ALIGN WITH EXPECTATIONS DERIVED FROM PUBLISHED LITERATURE. REFERENCES 1. ZEITLER EP, BIAN B, GRIFFITHS RI, ET AL. LONG-TERM CLINICAL OUTCOMES FOLLOWING THE WATCHMAN DEVICE USE IN MEDICARE BENEFICIARIES. CIRC CARDIOVASC QUAL OUTCOMES. OCT 2024;17(10):E011007. DOI:10.1161/CIRCOUTCOMES.124.011007 2. HIGGINS AY, ZIMMERMAN S, WANG Y, ET AL. LONG-TERM OUTCOMES FOLLOWING LEFT ATRIAL APPENDAGE OCCLUSION IN MEDICARE BENEFICIARIES: OUTCOMES FROM THE NATIONAL CARDIOVASCULAR DATA REGISTRY. J AM HEART ASSOC. AUG 19 2025;14(16):E039780. DOI:10.1161/JAHA.124.039780 3. OSMANCIK P, HERMAN D, NEUZIL P, ET AL. 4-YEAR OUTCOMES AFTER LEFT ATRIAL APPENDAGE CLOSURE VERSUS NONWARFARIN ORAL ANTICOAGULATION FOR ATRIAL FIBRILLATION. J AM COLL CARDIOL. JAN 4 2022;79(1):1-14. DOI:10.1016/J.JACC.2021.10.023 4. GALEA R, DE MARCO F, AMINIAN A, ET AL. 3-YEAR CLINICAL OUTCOMES COMPARING THE AMULET VS WATCHMAN FLX FOR LEFT ATRIAL APPENDAGE CLOSURE IN PATIENTS WITH ATRIAL FIBRILLATION: RESULTS FROM THE SWISS-APERO RANDOMIZED CLINICAL TRIAL. J AM COLL CARDIOL. JUL 8 2025;86(1):3-14. DOI:10.1016/J.JACC.2025.03.535 5. KAPADIA SR, YEH RW, PRICE MJ, ET AL. OUTCOMES WITH THE WATCHMAN FLX IN EVERYDAY CLINICAL PRACTICE FROM THE NCDR LEFT ATRIAL APPENDAGE OCCLUSION REGISTRY. CIRC CARDIOVASC INTERV. SEP 2024;17(9):E013750. DOI:10.1161/CIRCINTERVENTIONS.123.013750 6. PRICE MJ, SLOTWINER D, DU C, ET AL. CLINICAL OUTCOMES AT 1 YEAR FOLLOWING TRANSCATHETER LEFT ATRIAL APPENDAGE OCCLUSION IN THE UNITED STATES. JACC CARDIOVASC INTERV. APR 11 2022;15(7):741-750. DOI:10.1016/J.JCIN.2022.02.009 RACE: AMERICAN INDIAN OR ALASKA NATIVE 21 (0.3%), ASIAN 103 (1.6%), BLACK 134 (2.1%), OTHER PACIFIC ISLANDER 3 (0.0%), OTHER RACE 79 (1.2%), UNKNOWN 451 (3.1%), AND WHITE 5841 (91.3%) ETHNICITY: HISPANIC OR LATINO 197 (3.1%), AND NOT HISPANIC OR LATINO 5968 (93.3%) DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION.

Description of Event or Problem · 0

Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that an ischemic stroke occurred within 3 years post WATCHMAN FLX implant procedure;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0133,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that bleeding occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0506,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that a systemic embolism occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0503,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that a systemic embolism occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0503,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that a systemic embolism occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0503,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that a systemic embolism occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0503,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that a systemic embolism occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0503,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that a systemic embolism occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0503,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that a systemic embolism occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0503,F12,A24,G07001,B17,C19,D12,,0;21268444,01/01/2020,12/12/2025,10/06/2025,WATCHMAN FLX,"system, appendage closure, left atrial",Unknown,Unknown,Unknown,NA,Unknown,P130013 ,10/06/2025,IN,"It was reported that a systemic embolism occurred within three years after the WATCHMAN FLX implant procedure.;;Type of Procedure: Left Atrial Appendage Closure;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to assess outcomes in patients with a LAAC device compared to those on NOAC. We are reporting on a propensity-score matched cohort with 3-year event rates for WM FLX. Reported outcomes include the primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, hemorrhagic stroke, systemic embolism, all-cause death. The implant procedures were performed from January 2020 to Oct 2024. Within this analysis, the total patient population size was 6 393 individuals.;;Patient events were identified as first event rates and the number of patients with an event for several outcomes at 3 years post-procedure (WM). Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC.","Time Frame of Event Date Collection: Patients in TRUVETA health systems implanted with WATCHMAN FLX device between January 2020 and October 2024.;;Summary of Adverse Events: The analysis reports on a propensity-score matched cohort to assess outcomes in patients with a left atrial appendage closure (LAAC) device compared to those receiving non-vitamin K antagonist oral anticoagulants (NOAC). The evaluation includes 90-day event rates for WATCHMAN FLX Pro and 3-year event rates for WATCHMAN FLX. Reported outcomes encompass the following: primary endpoint 1 (stroke, death, and systemic embolism), primary endpoint 2 (non-procedural bleeding), ischemic stroke, systemic embolism, and all-cause mortality.;;Total Number of Patients: 6397;;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU).;;Contextual Analysis of Study Data:;Overall, the 3-year outcomes after WATCHMAN FLX implant and 90-day outcomes after WATCHMAN FLX Pro implant that were found during this analysis of the Truveta database align with what is expected based on published literature. The 3-year individual event rates reported in this analysis for WATCHMAN FLX for death (12.8%), ischemic stroke (3.8%), and systemic embolism (0.29%) fall within or below expected ranges. Although 3-year published rates from similar registry-based analyses in the United States are limited, a Medicare-based analysis reported a 44.2% mortality rate at 5 years with an estimated 8-10% annual rate, leading toward an estimated 3-year rate of 24.0%-30.0%.1 This publication also found an estimated 1.0%-1.5% annual rate of ischemic stroke (6.6% at 5 years; 3.0%-4.5% at 3 years)(1). A similar Medicare-based analysis supports these results with key findings of an estimated 3-year ischemic stroke rate of 3.5%, and a mortality rate near 27% (2). A randomized trial with a similar goal of comparing LAAC and OACs observed a 15.6% rate for all-cause death at 3 years (3) and recent randomized trial looking specifically at WATCHMAN devices reported 3-year rates of 29.0% for death, 7.2% for ischemic stroke, and 2.2% for systemic embolism (4). ;The 90-day individual event rates reported in this analysis for WATCHMAN FLX Pro for death (0.56%), ischemic stroke (1.11%), and systemic embolism (0.25%) also fall within expected ranges. Although 90-day event rates are rarely reported, the rates found in this analysis from the Truveta database fall below or between reported 45-day and 1-year rates. In publications from a nationwide registry, rates of all-cause death ranged from 0.81% at 45 days to 8.2%(5) and 8.5%(6) at 1 year, ischemic stroke ranged from 0.23%(5) at 45 days to 1.2%(5) and 1.5%(6) at 1 year, and systemic embolism ranged from 0.01%(5) at 45 days to 0.68%(6) at 1 year. ;Thus, all 3-year and 90-day rates found in this analysis align with expectations derived from published literature.;;References;1. Zeitler EP, Bian B, Griffiths RI, et al. Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries. Circ Cardiovasc Qual Outcomes. Oct 2024;17(10):e011007. doi:10.1161/CIRCOUTCOMES.124.011007;2. Higgins AY, Zimmerman S, Wang Y, et al. Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry. J Am Heart Assoc. Aug 19 2025;14(16):e039780. doi:10.1161/JAHA.124.039780;3. Osmancik P, Herman D, Neuzil P, et al. 4-Year Outcomes After Left Atrial Appendage Closure Versus Nonwarfarin Oral Anticoagulation for Atrial Fibrillation. J Am Coll Cardiol. Jan 4 2022;79(1):1-14. doi:10.1016/j.jacc.2021.10.023;4. Galea R, De Marco F, Aminian A, et al. 3-Year Clinical Outcomes Comparing the Amulet vs Watchman FLX for Left Atrial Appendage Closure in Patients With Atrial Fibrillation: Results From the SWISS-APERO Randomized Clinical Trial. J Am Coll Cardiol. Jul 8 2025;86(1):3-14. doi:10.1016/j.jacc.2025.03.535;5. Kapadia SR, Yeh RW, Price MJ, et al. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circ Cardiovasc Interv. Sep 2024;17(9):e013750. doi:10.1161/CIRCINTERVENTIONS.123.013750;6. Price MJ, Slotwiner D, Du C, et al. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovasc Interv. Apr 11 2022;15(7):741-750. doi:10.1016/j.jcin.2022.02.009;;Race: American Indian or Alaska Native 21 (0.3%), Asian 103 (1.6%), Black 134 (2.1%), Other Pacific Islander 3 (0.0%), Other Race 79 (1.2%), Unknown 451 (3.1%), and White 5841 (91.3%);;Ethnicity: Hispanic or Latino 197 (3.1%), and Not Hispanic or Latino 5968 (93.3%);;Detailed product information was not provided to BSC. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other specific product information.",,Average 78 years,Male 3721 (58.2%),,,,E0503,F12,A24,G07001,B17,C19,D12,,0;,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,;,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,;,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,;,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,;,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,;,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,;,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,;,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,;,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,;,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,;,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,;,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,;

Description of Event or Problem · 0

THIS REPORT SUMMARIZES 132 ISCHEMIC STROKES, 411 NON-PROCEDURAL BLEEDING AND 8 SYSTEMIC EMBOLISMS REPORTED 3 YEARS AFTER WATCHMAN FLX IMPLANT PROCEDURE. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. MEAN POPULATION AGE AT IMPLANT: 78 YEARS. GENDER: MALE 3721 (58.2%). TYPE OF PROCEDURE: LEFT ATRIAL APPENDAGE CLOSURE. BOSTON SCIENTIFIC PERFORMED A RETROSPECTIVE DATA ANALYSIS USING THE AGGREGATE ELECTRONIC HEALTH RECORD DATABASE FROM TRUVETA. THIS ANALYSIS AIMED TO ASSESS OUTCOMES IN PATIENTS WITH A LAAC DEVICE COMPARED TO THOSE ON NOAC. WE ARE REPORTING ON A PROPENSITY-SCORE MATCHED COHORT WITH 3-YEAR EVENT RATES FOR WM FLX. REPORTED OUTCOMES INCLUDE THE PRIMARY ENDPOINT 1 (STROKE, DEATH, AND SYSTEMIC EMBOLISM), PRIMARY ENDPOINT 2 (NON-PROCEDURAL BLEEDING), ISCHEMIC STROKE, HEMORRHAGIC STROKE, SYSTEMIC EMBOLISM, ALL-CAUSE DEATH. THE IMPLANT PROCEDURES WERE PERFORMED FROM (B)(6) 2020 TO (B)(6) 2024. WITHIN THIS ANALYSIS, THE TOTAL PATIENT POPULATION SIZE WAS 6 393 INDIVIDUALS. PATIENT EVENTS WERE IDENTIFIED AS FIRST EVENT RATES AND THE NUMBER OF PATIENTS WITH AN EVENT FOR SEVERAL OUTCOMES AT 3 YEARS POST-PROCEDURE (WM). MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT. DATA OBTAINED FROM TRUVETA FOR THIS STUDY IS DE-IDENTIFIED BEFORE BEING ACCESSED BY BOSTON SCIENTIFIC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO OUR ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED AS A SPONTANEOUS COMPLAINT. THE STUDY DATA DOES NOT PROVIDE A CAUSALITY RELATIONSHIP FOR EACH REPORTED EVENT TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE TO BSC.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2769463	WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM	SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL	NGV	BOSTON SCIENTIFIC CORPORATION

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR	Unknown

Terms

Patient problem · 3

• Embolism/Embolus
• Hemorrhage/Blood Loss/Bleeding
• Stroke/CVA

Product problems · 1

• Adverse Event Without Identified Device or Use Problem

Source type · 1

• Other

Type of report · 1

• Initial submission