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	11/28/2025
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.Prior to implant procedure, aspirin was administered.On (b)(6) 2022, the patient underwent successful placement of 27 mm watchman flx device.On (b)(6) 2022, the patient was discharged on apixaban (10 mg/day), clopidogrel (75 mg/day) and aspirin (81 mg/day).On (b)(6) 2025, 1353 days post index procedure, the patient passed away.Per edc, the home health company was unable to reach the patient by phone or email since (b)(6) 2025, so they contacted the local police department to request a wellness check on the patient and the police found the patient deceased inside home.At the time of death, the patient was on aspirin (81mg/day).There was no action taken and diagnostics performed in response to the event.No further information is currently available, and site has been queried for the same.

• 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: 23768361
• Report Number: 2124215-2025-90117
• Device Sequence Number: 10615389
• Product Code: NGV
• UDI-Device Identifier: 08714729860501
• UDI-Public: (01)08714729860501
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 12/10/2025

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 Model Number: M635WU50270
• Device Catalogue Number: M635WU50270
• 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: 12/02/2025
• Initial Report FDA Received Date: 12/10/2025
• 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: Death
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Race: White