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

Model Number	M635WU60310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Transient Ischemic Attack (2109); Numbness (2415); Speech Disorder (4415); Facial Paralysis (4585)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a transient ischemic attack occurred.A left atrial appendage (laa) closure procedure was performed, and a 31mm watchman flx pro closure device was implanted on (b)(6) 2026.The patient was discharged on plavix 75 mg and asa 81 mg.As a plavix non-responder, the patient was switched to brilinta 90 mg twice a day while inpatient.On (b)(6) 2026, the patient was admitted with cerebral vascular accident (cva) symptoms, the patient had left sided weakness, left facial droop, slurred speech and decreased sensation.On (b)(6) 2026, a head computed tomography (ct) was performed and imaging showed no acute findings.Carotid imaging demonstrated no flow-limiting stenosis.A magnetic resonance imaging (mri) could not be performed due to an incompatible pacemaker (pm).During the procedure a complete seal was noted and there were no changes to the seal of the closure device.The patient symptoms resolved within 24 hours, and the patient fully recovered.The patient was discharged home on brilinta 90mg twice a day.

• 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: 50692788
• Report Number: 2124215-2026-48164
• Device Sequence Number: 9595251
• Product Code: NGV
• UDI-Device Identifier: 00191506004613
• UDI-Public: (01)00191506004613(17)281221(10)38244427
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• 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: M635WU60310
• Device Catalogue Number: M635WU60310
• Device Lot Number: 0038244427
• 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: 08/24/2026
• Supplement Date Received by Manufacturer: 09/25/2026; 09/29/2026
• Initial Report FDA Received Date: 09/09/2026
• Supplement Report FDA Received Date: 09/29/2026; 09/30/2026
• Date Device Manufactured: 12/22/2025
• 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: Hospitalization; Other
• Patient Age: 81 YR
• Patient Sex: Male