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	Stroke/CVA (1770); Cognitive Changes (2551); Confusion/ Disorientation (2553)
Date of Event	03/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported via clinical study.It was reported that a stroke occurred.A left atrial appendage closure (laac) procedure was performed.A 24mm watchman flx laa closure was implanted on (b)(6) 2022.On (b)(6) 2026, the patient presented acutely confused.The physician initially considered the symptoms related to a recent extubation, medical comorbidities and likely sundowning.The symptoms continued the next day, so computed tomography (ct) imaging of the patient head was ordered.The ct showed concerns for right posterior cerebral artery (pca) infarct.The patient was experiencing hallucinations, which worsened in the evening hours.The national institutes of health (nih) stroke score was 4.The patient was not given tenecteplase (tnk) but was on bival.There was suspicion of embolic etiology due to impella placement.Computed tomography angiography (cta) of the head and neck was negative on (b)(6) 2026.By (b)(6) 2026, the patient symptoms improved and no additional stroke work up was completed.

• 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 H91 Y 868; EI H91 Y868
• Manufacturer Contact: mary crawford ; 4100 hamline ave n; arden hills, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50244655
• Report Number: 2124215-2026-43568
• Device Sequence Number: 10414683
• Product Code: NGV
• UDI-Device Identifier: 08714729860495
• UDI-Public: (01)08714729860495(17)250419(10)29254223
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: 04/19/2025
• Device Model Number: M635WU50240
• Device Catalogue Number: M635WU50240
• Device Lot Number: 0029254223
• 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: 08/10/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 08/13/2026
• Supplement Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 04/20/2022
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 300 LB