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

Model Number	M635WU50270
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Dizziness (2194)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device embolization occurred.A left atrial appendage (laa) closure procedure was performed a 27mm watchman flx closure device was implanted on (b)(6) 2023.The patient was discharged.During review of the implant procedure, it appeared that the closure device left a shoulder about 1/3 the device.The physician stated that during the routine 45-day follow up, the closure device appeared almost 50 percent out but no intervention or follow up transesophageal echocardiography were performed.The patient presented to the hospital on (b)(6) 2025 with weakness and dizziness.Heparin was administrated to the patient.The patient did not have any focal neuro deficits.The patient was scheduled for device extraction and device reimplantation on (b)(6) 2025.The physician was concerned about possible clot within the closure device and extraction through a sheath with release of clots/micro clots.The hospital was able to obtain permission for use of the non-boston scientific (bsc) emboliner device which is still be researched.The closure device was extracted using a non-bsc snare device and a new 24mm closure device was implanted.The 24mm closure device did not meet position, anchor, size and seal (pass) criteria, as two of the compression measurements were between 8 and 9 percent.The remaining two compressions were 12.5 and 11.3 percent.The physician released the device as the rest of the pass criteria were met.The physician was aware that two of the compressions were below 10 percent.The patient was discharged with no neuro deficits.

• 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: 23511146
• Report Number: 2124215-2025-80987
• Device Sequence Number: 13286260
• Product Code: NGV
• UDI-Device Identifier: 08714729860501
• UDI-Public: (01)08714729860501(17)251211(10)30697682
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted 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
• Report Date (Section B): 11/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2025
• Device Model Number: M635WU50270
• Device Catalogue Number: M635WU50270
• Device Lot Number: 0030697682
• 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: 10/30/2025
• Initial Report FDA Received Date: 11/10/2025
• Date Device Manufactured: 12/12/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Race: White