MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FLX?; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	M635WU50270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported via clinical study.It was reported an acute cortical infarct occurred.A left atrial appendage closure (laac) procedure was performed.A 27mm watchman flx laa closure device & delivery system (wds) was implanted on (b)(6) 2021 with complete laa seal and a deployed device diameter of 22 mm.The patient was discharged the same day on a medication regime of apixaban (10 mg/day) and aspirin (81 mg/ day).On (b)(6) 2024, 1162 days post index procedure, the patient presented to emergency department (ed) due to left arm numbness and loss of balance.Cardiac imaging, electrocardiogram (ecg) and lab tests were performed.Brain imaging performed revealed acute cortical infarct.The patient was on aspirin (81 mg/ day) at the time of reporting.On (b)(6) 2024, the outcome of the event was considered to be resolved.On (b)(6) 2024, the patient was started on apixaban (10 mg/day) in response to the event.On (b)(6) 2025, the dosage of apixaban (10mg/day) was reduced to apixaban (5 mg/day).

• Brand Name: WATCHMAN FLX?
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22977663
• Report Number: 2124215-2025-62241
• Device Sequence Number: 21189797
• Product Code: NGV
• UDI-Device Identifier: 08714729860501
• UDI-Public: (01)08714729860501(17)240519(10)27351309
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/19/2024
• Device Model Number: M635WU50270
• Device Catalogue Number: M635WU50270
• Device Lot Number: 0027351309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 09/05/2025
• Date Device Manufactured: 05/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Race: White