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

Model Number	M635WU50200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Transient Ischemic Attack (2109)
Date of Event	12/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported via clinica study.It was reported that a transient ischemic attack (tia) occurred.On (b)(6) 2021 the patient underwent a left atrial appendage (laa) closure procedure with successful placement of a 20 mm watchman flx device and deployed device diameter of 15.5 mm.The patient was discharged the next day on aspirin (81 mg/day) and rivaroxaban (20 mg /day).On (b)(6) 2025, 1569 days post index procedure, the patient presented to the to the emergency room (er) with symptoms concerning for acute cerebral vascular accident (cva) versus tia.During er visit, electrocardiogram (ekg) was performed which revealed no evidence of stemi or ischemia.On the same day, labs were performed with no hypoglycemia metabolic derangements.On physical examination, there was no focal neurological deficits, speech, motor and sensation were intact and able to ambulate with a steady gait.A computed tomography (ct) scan of the head was performed which revealed no acute intracranial abnormalities, hemorrhage or large territorial infarct.Neurology was consulted and recommended magnetic resonance imaging (mri) to rule out acute or chronic infract.Mri showed no acute intracranial abnormality.The clinical site reported the event as a tia.The patient was on aspirin (81 mg /day) at the time of the event.Nih stroke scale (nihss) score was noted to be 0.The patient was started on clopidogrel (75 mg/day) in response to the event and was instructed to follow up with tia or stroke clinic as outpatient as well as to follow up with their primary care provider within 24-48 hours.The patient symptoms were fully resolved without deficit on (b)(6) 2025.

• 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: 24044094
• Report Number: 2124215-2026-01896
• Device Sequence Number: 21101079
• Product Code: NGV
• UDI-Device Identifier: 08714729860488
• UDI-Public: (01)08714729860488(17)240707(10)27627839
• 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: 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): 01/12/2026

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: 07/07/2024
• Device Model Number: M635WU50200
• Device Catalogue Number: M635WU50200
• Device Lot Number: 0027627839
• 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: 12/30/2025
• Initial Report FDA Received Date: 01/12/2026
• Date Device Manufactured: 07/08/2021
• 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: Hospitalization; Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Race: White