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); Thrombosis/Thrombus (4440); Facial Paralysis (4585)
Date of Event	08/31/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that death occurred.This was a concomitant atrial fibrillation ablation procedure with farapulse, and a left atrial appendage (laa) closure procedure that was performed, a 35mm watchman flx pro closure device was implanted on (b)(6) 2026.During the procedure heparin was administered.It was reported by the research coordinator that post procedure the patient experienced a stroke, which resulted in death, the patient passed away on (b)(6) 2026.The mechanism of the stroke was hemorrhagic.The research coordinator believed the cause of death on certificate was stroke.
Event or Problem Description
It was reported that death occurred.This was a concomitant atrial fibrillation ablation procedure with farapulse, and a left atrial appendage (laa) closure procedure that was performed, a 35mm watchman flx pro closure device was implanted on (b)(6) 2026.During the procedure heparin was administered.It was reported by the research coordinator that post procedure the patient experienced a stroke, which resulted in death, the patient passed away on (b)(6) 2026.The mechanism of the stroke was hemorrhagic.The research coordinator believed the cause of death on certificate was stroke.It was further reported that the patient had multiple comorbidities including severe right atrium (ra) enlargement and severe left ventricle (lv) dysfunction.The physician believes that these comorbidities along with large transseptal puncture and left atrial intra cardiac echocardiography (ice) could have contributed to clot formation.The stroke was thrombotic in nature and a thrombectomy was performed on the patient.The thrombus was not cardiac.During the procedure heparin was administered before transseptal, the first activated clotting time (act) was five (5) minutes after heparin.
Additional Manufacturer Narrative
B5 describe event or problem: updated with additional information received.H6: patient code added.H6: impact code added.

• 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: 50825382
• Report Number: 2124215-2026-50027
• Device Sequence Number: 13431261
• Product Code: NGV
• UDI-Device Identifier: 00191506004620
• UDI-Public: (01)00191506004620(17)290408(10)39047488
• 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,Followup
• Report Date (Section B): 09/23/2026

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: 09/16/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/18/2026
• Supplement Report FDA Received Date: 09/23/2026
• 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: Death
• Patient Age: 80 YR
• Patient Sex: Female