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	Stroke/CVA (1770)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 date of event: aware date was used as event date as actual event date of the stroke was not known.
Event or Problem Description
Reported via patient call center it was reported via the watchman patient call center that a patient experienced two strokes.A left atrial appendage (laa) closure procedure was performed, and a 24mm watchman laa closure device was implanted on (b)(6) 2020.The patient reported that since having the watchman placed, he has had two small strokes.The patient stated that he does not recall having any follow up testing after his procedure.The patient stated he continued taking eliquis until 2022 when he had to stop it for a prostate surgery and he never restarted it after the prostate procedure.The patient reported he then had a small stroke and had another one in (b)(6) 2024 and was then put back on eliquis.No further information was provided.

• 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: 21980571
• Report Number: 2124215-2025-29325
• Device Sequence Number: 8781832
• Product Code: NGV
• UDI-Device Identifier: 08714729838234
• UDI-Public: (01)08714729838234(17)230109(10)25018691
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2025

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: 01/09/2023
• Device Model Number: M635WU24060
• Device Catalogue Number: M635WU24060
• Device Lot Number: 0025018691
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/07/2025
• Date Device Manufactured: 01/10/2020
• 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: 81 YR
• Patient Sex: Unknown