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

Model Number	M635WU50270
Medical Device Problem Codes	Migration (4003); Failure to Seal (4070)
Health Effect - Clinical Codes	Stroke/CVA (1770); Speech Disorder (4415)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a cerebral vascular accident (cva) occurred.The patient previously underwent a left atrial appendage (laa) closure procedure on (b)(6) 2021, during which a 27mm watchman flx laa closure device was implanted.Post-procedure, the patient was discharged on xarelto for 45 days, after which the medication was switched to plavix until the 6-month follow-up.On (b)(6) 2025, the patient presented to the hospital with symptoms of speech delay.It was noted that the patient had a watchman device implanted in 2021.A transesophageal echocardiography (tee) was performed, which revealed that the device was canted within the appendage and showed residual flow/leak of 3-5mm past the appendage.There was no thrombus noted.The patient was restarted on oral anticoagulation (oac) therapy.The 45-day tee from the implanting hospital was reviewed.The implanting physician documented that the closure device appeared well-seated at the ostium with no flow around it.However, upon further review, the imaging suggested that the device was already canted at the ostium and likely had flow beneath the device, though the original imaging quality was suboptimal.There is no intervention planned at this time.

• 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: 23607925
• Report Number: 2124215-2025-84688
• Device Sequence Number: 9444930
• Product Code: NGV
• UDI-Device Identifier: 08714729860501
• UDI-Public: (01)08714729860501(17)240527(10)27399447
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 11/20/2025

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: 05/27/2024
• Device Model Number: M635WU50270
• Device Catalogue Number: M635WU50270
• Device Lot Number: 0027399447
• 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: 11/13/2025
• Initial Report FDA Received Date: 11/20/2025
• Date Device Manufactured: 05/28/2021
• 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; Hospitalization
• Patient Sex: Unknown