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

Model Number	M635WU50310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: event date - aware date was used as event date as the actual event date is not known.
Event or Problem Description
It was reported that thrombosis occurred.A left atrial appendage (laa) closure procedure was performed, and a 31mm watchman flx closure device was successfully implanted on (b)(6) 2023.The patient was discharged.During an unknown time, the patient had a transesophageal echocardiography (tee), and the physician noted a device related thrombus near the threaded insert.No further information was provided at the time of this report.
Event or Problem Description
It was reported that thrombosis occurred.A left atrial appendage (laa) closure procedure was performed, and a 31mm watchman flx closure device was successfully implanted on (b)(6) 2023.The patient was discharged.During an unknown time, the patient had a transesophageal echocardiography (tee), and the physician noted a device related thrombus near the threaded insert.No further information was provided at the time of this report.
Additional Manufacturer Narrative
B3: event date - aware date was used as event date as the actual event date is not known.The device was not returned for analysis as the device remains implanted; therefore, a technical analysis could not be performed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.

• 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: 24335090
• Report Number: 2124215-2026-08305
• Device Sequence Number: 21277564
• Product Code: NGV
• UDI-Device Identifier: 08714729860518
• UDI-Public: (01)08714729860518(17)260320(10)31271860
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 03/20/2026
• Device Model Number: M635WU50310
• Device Catalogue Number: M635WU50310
• Device Lot Number: 0031271860
• 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: 02/09/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 03/21/2023
• 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: 75 YR
• Patient Sex: Male