MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FLX; system, appendage closure, left atrial

Model Number	M635WU50200
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	08/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a stroke occurred.A left atrial appendage closure (laac) procedure was performed, and a 20mm watchman flx laa closure device was implanted on (b)(6) 2024.The patient was discharged on a regimen of aspirin and 75mg of plavix.Computed tomography angiography (cta) was completed at the routine 45 day follow up.A 4mm leak was noted.Plavix was discontinued.The patient had magnetic resonance imaging (mri) done on the brain on (b)(6) 2026 and was diagnosed with a stroke.The patient was not taking any antithrombotic medication at the time of the stroke.

• 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 H91 Y 868; EI H91 Y868
• Manufacturer Contact: mary crawford ; 4100 hamline ave n; arden hills, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50802942
• Report Number: 2124215-2026-49655
• Device Sequence Number: 8900496
• Product Code: NGV
• UDI-Device Identifier: 08714729860488
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 06/15/2026
• Device Model Number: M635WU50200
• Device Catalogue Number: M635WU50200
• Device Lot Number: 0031832093
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 06/16/2023
• 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: 68 YR
• Patient Sex: Male