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

Model Number	M635WU60400
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an implant embolization occurred.A left atrial appendage (laa) closure procedure was performed and a 40mm watchman flx pro closure device was implanted.The following day post index procedure, a transesophageal echocardiogram (tee) was performed which revealed the closure device had embolized out of the laa and into the left atrium.The patient's family is deciding whether or not to have the physicians perform heart surgery.
Additional Manufacturer Narrative
B5: information added.H6 impact code added: medication required.
Event or Problem Description
It was reported an implant embolization occurred.A left atrial appendage (laa) closure procedure was performed and a 40mm watchman flx pro closure device was implanted.The following day post index procedure, a transesophageal echocardiogram (tee) was performed which revealed the closure device had embolized out of the laa and into the left atrium.The patient's family is deciding whether or not to have the physicians perform heart surgery.It was further reported the patient's family did not want to risk another procedure, so the hospital is discharging the patient with anticoagulant medication as a response to the event.The patient has been discharged.

• 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23677043
• Report Number: 2124215-2025-86116
• Device Sequence Number: 8910529
• Product Code: NGV
• UDI-Device Identifier: 00191506004637
• UDI-Public: (01)00191506004637(17)280417(10)36322890
• Combination Product (Y/N): N
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M635WU60400
• Device Catalogue Number: M635WU60400
• Device Lot Number: 0036322890
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/30/2025
• Supplement Report FDA Received Date: 12/17/2025
• Date Device Manufactured: 04/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Race: White