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

Model Number	M635WU50270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2026
Type of Reportable Event	Death
Event or Problem Description
Reported via clinical study.It was reported that death occurred.A left atrial appendage (laa) closure procedure was performed.The patient was on apixaban (10 mg/day) therapy prior to enrollment into the study.On (b)(6) 2023 implant transesophageal echocardiography (tee) assessment revealed 2 laa lobes with an ostium diameter of 23.3 mm and length of 39.1mm.On (b)(6) 2023, the patient got crossover and successful placement of 27mm watchman flx device with complete laa seal and deployed device diameter of 22.7mm.Prior to the implant procedure aspirin was administered.The patient was discharged on the same day on apixaban (10 mg/day) and aspirin (81 mg/day).On (b)(6) 2026,1039 days post index procedure, the patient passed away and the cause of death is unknown.At the time of death, the patient was not on any anticoagulant/ antiplatelet medication.No action taken and diagnostics was performed in response to the event.No further information available at this time.
Event or Problem Description
Reported via clinical study: it was reported that death occurred.A left atrial appendage (laa) closure procedure was performed.The patient was on apixaban (10 mg/day) therapy prior to enrollment into the study.On (b)(6) 2023 implant transesophageal echocardiography (tee) assessment revealed 2 laa lobes with an ostium diameter of 23.3 mm and length of 39.1mm.On (b)(6) 2023, the patient got crossover and successful placement of 27mm watchman flx device with complete laa seal and deployed device diameter of 22.7mm.Prior to the implant procedure aspirin was administered.The patient was discharged on the same day on apixaban (10 mg/day) and aspirin (81 mg/day).On (b)(6) 2026,1039 days post index procedure, the patient passed away and the cause of death is unknown.At the time of death, the patient was not on any anticoagulant/ antiplatelet medication.No action taken and diagnostics was performed in response to the event.No further information available at this time.It was further reported that the sponsor device causality assessment is not related, the complaint will be close as not a complaint.
Additional Manufacturer Narrative
B5 describe event or problem: updated with additional information received.H6: impact code updated to f26 no health consequences or impact.

• 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: 50165898
• Report Number: 2124215-2026-42283
• Device Sequence Number: 5253925
• Product Code: NGV
• UDI-Device Identifier: 08714729860501
• UDI-Public: (01)08714729860501(17)260530(10)31726676
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2026

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: 05/30/2026
• Device Model Number: M635WU50270
• Device Catalogue Number: M635WU50270
• Device Lot Number: 0031726676
• 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: 07/22/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 08/24/2026
• Date Device Manufactured: 05/31/2023
• 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: Death
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 185 LB