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

Model Number	M635WU50270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	12/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported via patient call center it was reported that thrombosis occurred.A left atrial appendage (laa) closure procedure was performed, and a 27mm watchman flx pro closure device was successfully implanted on (b)(6) 2023.The patient was discharged.The patient stated that in (b)(6) 2024 prior to ablation the physician noted a blood clot on closure device via a transesophageal echocardiography (tee).The patient was on eliquis and now is on warfarin.The patient stated that a repeat tee was performed and imaging showed that the clot remains on the closure device.According to the physician the clot has reduced slightly.The patient stated wanting to know the alternatives and was referred back to the cardiologist.No further information was provided at the time of this report.

• 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: 23625654
• Report Number: 2124215-2025-85536
• Device Sequence Number: 9051277
• Product Code: NGV
• UDI-Device Identifier: 08714729860501
• UDI-Public: (01)08714729860501(17)260402(10)31363042
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2025

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: 04/02/2026
• Device Model Number: M635WU50270
• Device Catalogue Number: M635WU50270
• Device Lot Number: 0031363042
• 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: 11/11/2025
• Initial Report FDA Received Date: 11/22/2025
• Date Device Manufactured: 04/03/2023
• 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: 77 YR
• Patient Sex: Unknown