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	07/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that cerebral vascular accident occurred.A left atrial appendage (laa) closure procedure was performed, and a 24mm watchman delivery system (wds) was implanted on (b)(6) 2018.The patient was discharged.The patient's wife stated that the patient had a stroke on (b)(6) 2024.The patient was taking baby aspirin prior the procedure and after the implant of the closure device.The patient continues to take it, with no other blood thinner prescribed.It was stated that the patient did not have any follow up testing done after the procedure.No further information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis as the device remains implanted; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
Reported via patient call center.It was reported that cerebral vascular accident occurred.A left atrial appendage (laa) closure procedure was performed, and a 24mm watchman delivery system (wds) was implanted on (b)(6) 2018.The patient was discharged.The patient's wife stated that the patient had a stroke on (b)(6) 2024.The patient was taking baby aspirin prior the procedure and after the implant of the closure device.The patient continues to take it, with no other blood thinner prescribed.It was stated that the patient did not have any follow up testing done after the procedure.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: 24916456
• Report Number: 2124215-2026-21051
• Device Sequence Number: 9195689
• Product Code: NGV
• UDI-Device Identifier: 08714729838234
• UDI-Public: (01)08714729838234(17)210204(10)21700271
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: 02/04/2021
• Device Model Number: M635WU24060
• Device Catalogue Number: M635WU24060
• Device Lot Number: 0021700271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/14/2026
• Date Device Manufactured: 02/05/2018
• 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: Male