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

Model Number	M635WU60310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that thrombosis occurred.A left atrial appendage (laa) closure procedure was performed, and a 31mm watchman flx pro closure device was implanted on (b)(6) 2024.The patient was discharged.The patient had a follow up computed tomography (ct) scan performed on (b)(6) 2026, to evaluate a non-mobile thrombus located towards the limbus side that was previously discovered on a computed tomography (ct) performed on (b)(6) 2025, and to evaluate the contrast patency of the closure device as well.The watchman clinical evaluated the ct that was done on (b)(6) 2026 and asked to also see the ct from on (b)(6) 2025, to be able to compare previous ct with the current ct.Based on what the watchman clinical had seen, both of the cts were sent to the therapy operations team for additional evaluation as well.The watchman clinical has not heard back from the therapy operations team yet to get their impression of the ct.During the procedure, the closure device met all of position, anchor, size and seal (pass) criteria the day of implant.After evaluating the cts, the closure device still meets all of pass criteria.Before implant, the patient was on eliquis and aspirin (asa).Now the patient is still on xarelto.It is unknown and unavailable per the facility right now as to what treatment will be done.The physician is waiting on the report from the watchman clinical and therapy ops team to see what the next steps will be for the patient.

• 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: 50896846
• Report Number: 2124215-2026-51142
• Device Sequence Number: 10761900
• Product Code: NGV
• UDI-Device Identifier: 00191506004613
• UDI-Public: (01)00191506004613(17)270704(10)34371121
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: M635WU60310
• Device Catalogue Number: M635WU60310
• Device Lot Number: 0034371121
• 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: 09/21/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 07/04/2024
• 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: 68 YR
• Patient Sex: Male