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

Model Number	M635WU60350
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Stroke/CVA (1770); Muscle Weakness/Atrophy (1967); Dizziness (2194); Speech Disorder (4415)
Date of Event	08/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported implant movement/shift and stroke occurred.A left atrial appendage (laa) closure procedure was performed, and a 35mm watchman flx pro closure device was implanted on (b)(6) 2025.The patient was subsequently discharged.In (b)(6) 2026, while traveling in miami, florida, the patient presented to an emergency department where it was reported that the patient had experienced a stroke with symptoms of dizziness, aphasia, and right sided weakness while on a flight.A transesophageal echocardiography (tee) examination was performed and revealed that the closure device was positioned outside of the left atrial appendage and appeared to be engaged only with a portion of the coumadin ridge.Additionally, it was noted that there was no evidence of endothelialization.No thrombus was noted on the closure device.There was no intervention performed.The imaging confirmed an acute ischemic stroke; left anterior corona radiata with two punctate subacute/late subacute lacunar infarcts.The treating physician at the hospital stated that the patient had undergone a follow-up tee approximately six months after the implant procedure with the implanting physician and was advised at that time that blood thinner medication could be discontinued.The hospital physician elected not to intervene with the closure device and instead referred the patient back to the implanting physician for further evaluation and management following discharge and return home to georgia.
Additional Manufacturer Narrative
B3 date of event: event date estimated as (b)(6) 2026 as the event was reported to have occurred in (b)(6) 2026.D4: detailed product information was not provided to bsc.We completed good faith efforts to obtain the information.Because the product lot is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.

• 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 ; EI
• Manufacturer Contact: mary crawford ; 4100 hamline ave n; arden hills, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50787713
• Report Number: 2124215-2026-49335
• Device Sequence Number: 10571336
• Product Code: NGV
• UDI-Device Identifier: 00191506004620
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M635WU60350
• Device Catalogue Number: M635WU60350
• 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
• Initial Report FDA Received Date: 09/16/2026
• 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: 65 YR
• Patient Sex: Male