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

Model Number	M635WU24060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a device related thrombus.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) and a 24 mm watchman laa closure device and delivery system (wds) were selected to be used.The procedure was successfully completed with the closure device implanted in the laa of the patient.There were no patient complications that were reported to have occurred.Five (5) years post procedure the patient underwent a transesophageal echocardiogram (tee) imaging procedure.The imaging showed that there was a device related thrombus present on the posterior side of the closure device.The physician restarted the patient on coumadin in response to this event with a plan to perform a follow up tee at a future date.The patient is expected to make a full recovery and did not experience any other complications.

• Brand Name: WATCHMAN
• 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: 21327451
• Report Number: 2124215-2025-06458
• Device Sequence Number: 7822398
• Product Code: NGV
• UDI-Device Identifier: 08714729838234
• UDI-Public: 08714729838234
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2025

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: 10/20/2022
• Device Model Number: M635WU24060
• Device Catalogue Number: M635WU24060
• Device Lot Number: 0024628926
• 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: 01/31/2025
• Initial Report FDA Received Date: 02/06/2025
• Date Device Manufactured: 10/21/2019
• 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 Sex: Male