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

Model Number	M635WU50240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Transient Ischemic Attack (2109); Speech Disorder (4415)
Date of Event	07/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported via clinical report: it was reported that the patient experienced a transient ischemic attack.A left atrial appendage (laa) closure procedure was performed.On (b)(6) 2023, the patient underwent successful placement of a 24mm watchman flx closure device with a complete laa seal and deployed device diameter of 19.8 mm.On the same day, the patient was discharged on aspirin (81mg/day) and rivaroxaban (20 mg/day).On (b)(6) 2025, 798 days post index procedure, the patient presented to emergency department (ed) with complaints of speaking words that did not make sense which lasted for 10 minutes.On the same day, a computed tomography (ct) was performed which revealed no acute changes.At the time of the event, the patient was on aspirin 81 mg /day.No action was taken in response to the event.On (b)(6) 2025, the outcome of the event was considered to be resolved, and the patient was discharged from the emergency room (er).On (b)(6) 2025, modified rankin scale (mrs) was performed, and score was noted to be 0.On (b)(6) 2025, modified rankin scale (mrs) 90 days was performed, and score was noted to be 0.

• 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: 23359252
• Report Number: 2124215-2025-75318
• Device Sequence Number: 8815445
• Product Code: NGV
• UDI-Device Identifier: 08714729860495
• UDI-Public: (01)08714729860495(17)260219(10)31089191
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 10/22/2025

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: 02/19/2026
• Device Model Number: M635WU50240
• Device Catalogue Number: M635WU50240
• Device Lot Number: 0031089191
• 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: 10/13/2025
• Initial Report FDA Received Date: 10/22/2025
• Date Device Manufactured: 02/20/2023
• 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
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Race: White