MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FLX?; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	M635WU50350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Death
Event or Problem Description
Reported via clinical study it was reported that patient death occurred.A left atrial appendage (laa) closure procedure was performed.On (b)(6) 2022, underwent successful placement of 35 mm watchman flx device with complete laa seal and deployed device diameter of 30.0 mm.On (b)(6) 2022 the patient was discharged on aspirin (81 mg/day) and apixaban (5 mg/day).On (b)(6) 2025, 1269 days post index procedure, the patient passed away.Of note the cause of death is unknown and no other information or records are available.At the time of death, the patient was on aspirin (81 mg/day).No further information is currently available.
Event or Problem Description
Reported via clinical study.It was reported that patient death occurred.A left atrial appendage (laa) closure procedure was performed.On (b)(6) 2022, underwent successful placement of 35 mm watchman flx device with complete laa seal and deployed device diameter of 30.0 mm.On (b)(6) 2025 the patient was discharged on aspirin (81 mg/day) and apixaban (5 mg/day).On (b)(6) 2025, 1269 days post index procedure, the patient passed away.Of note the cause of death is unknown and no other information or records are available.At the time of death, the patient was on aspirin (81 mg/day).No further information is currently available.It was further reported that the patient expired at home while being on hospice care due to hypertensive heart disease with heart failure.
Additional Manufacturer Narrative
B5 describe event or problem: updated with additional information received.

• 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23316799
• Report Number: 2124215-2025-72959
• Device Sequence Number: 20075565
• Product Code: NGV
• UDI-Device Identifier: 08714729860525
• UDI-Public: (01)08714729860525(17)241115(10)28395393
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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: 11/15/2024
• Device Model Number: M635WU50350
• Device Catalogue Number: M635WU50350
• Device Lot Number: 0028395393
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/09/2025
• Date Device Manufactured: 11/16/2021
• 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: 83 YR
• Patient Sex: Male