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

Model Number	M635WU60350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Muscle Weakness/Atrophy (1967); Visual Disturbances (2140); Loss of consciousness (2418); Thromboembolism (2654); Speech Disorder (4415)
Date of Event	08/31/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported a stroke and patient death occurred.A left atrial appendage (laa) closure procedure was performed, and a 35mm watchman flx pro closure device was implanted.Immediately following the procedure, the patient exhibited right-sided weakness, inability to awaken, absence of speech attempts, inability to follow commands, and dysconjugate gaze.The patient was subsequently diagnosed with a stroke and was admitted to the hospital.In response to the stroke, thrombectomy was performed in interventional radiology to remove the clot and mechanical ventilation were performed.Four days following the index procedure, the patient died.The reported cause of death was thrombosis of the left middle cerebral artery (mca) with a large left mca infarct and significant cerebral edema resulting in a 1.8 cm left-to-right midline shift.The physician believed that a combination of preexisting comorbidities and the concomitant procedure led to the stroke.

• Brand Name: WATCHMAN FLX Pro
• 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: 50945914
• Report Number: 2124215-2026-51941
• Device Sequence Number: 21216027
• Product Code: NGV
• UDI-Device Identifier: 00191506004620
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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 Model Number: M635WU60350
• Device Catalogue Number: M635WU60350
• Device Lot Number: 0039047488
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 04/09/2026
• 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: Life Threatening; Required Intervention; Death; Hospitalization; Other
• Patient Age: 80 YR
• Patient Sex: Female