MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FLX? Pro; system, appendage closure, left atrial

Model Number	M635WU60240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Fall (1848); Paralysis (1997); Speech Disorder (4415)
Date of Event	02/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported via patient call center it was reported that cerebral vascular accident occurred.A left atrial appendage (laa) closure procedure was performed, and a 24mm watchman flx pro closure device was implanted on (b)(6) 2025.The patient was discharged.The patient stated they suffered a stroke in (b)(6) 2026 and was subsequently hospitalized for several days.During hospitalization, the patient noted the cardiologist advised that, the closure device was implanted as intended and they could not explain the cause of the stroke.The patient noted that they had been diagnosed with atrial fibrillation (af) for about twelve years.Prior to the closure device implant, the patient was taking warfarin.The patient's cardiologist wanted the patient off warfarin and suggested the closure device implant as an alternative.Post closure device implant, the patient was prescribed eliquis.The patient noted that on (b)(6) 2025, they had a follow up with the surgeon's nurse practitioner.The patient had another follow up visit with the surgeon's nurse practitioner on (b)(6) 2025, and at that time they were directed to stop taking eliquis blood thinner medication and to start taking 81mg of aspirin (asa) only.The patient could not recall if they underwent a transesophageal echocardiogram (tee) or computed tomography (ct) scan prior to or on (b)(6) 2025.The patient does not know the type of stroke suffered but advised that they do have residual effects from the stroke, including motor function and speech.The patient seems to be doing better and continues to be on 81mg asa only at this time.
Additional Manufacturer Narrative
B3: date of event is an approximate date as the actual event date is not known.

• Brand Name: WATCHMAN FLX? Pro
• 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: 50809238
• Report Number: 2124215-2026-49772
• Device Sequence Number: 8900180
• Product Code: NGV
• UDI-Device Identifier: 00191506004590
• UDI-Public: (01)00191506004590(17)280529(10)36641791
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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 Model Number: M635WU60240
• Device Catalogue Number: M635WU60240
• Device Lot Number: 0036641791
• 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: 08/28/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/17/2026
• Supplement Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 05/30/2025
• 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 Sex: Male