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

Model Number	M635WU60400
Medical Device Problem Codes	Material Deformation (2976); Migration (4003); Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device migration occurred and the implant did not seal.A left atrial appendage closure (laac) procedure was performed and a 40mm watchman flx pro laa closure device and delivery system (wds) was implanted on (b)(6) 2025.At the routine 45 day follow up, no concerns were reported.However, imaging at the one year follow up showed the device was tucked on the mitral side and there was a leak on the right side.The device was slightly distal and no longer met the position portion of the position, anchor, size and seal (pass) criteria.There was no additional information provided.
Event or Problem Description
It was reported that device migration occurred and the implant did not seal.A left atrial appendage closure (laac) procedure was performed and a 40mm watchman flx pro laa closure device and delivery system (wds) was implanted on (b)(6)2025.At the routine 45 day follow up, no concerns were reported.However, imaging at the one year follow up showed the device was tucked on the mitral side and there was a leak on the right side.The device was slightly distal and no longer met the position portion of the position, anchor, size and seal (pass) criteria.There was no additional information provided.It was further reported that there was no peri-device leak, but rather an intra-fabric flow.
Additional Manufacturer Narrative
B5: describe event or problem - updated.H6: device codes - updated.

• 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 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: 50803596
• Report Number: 2124215-2026-49676
• Device Sequence Number: 16097437
• Product Code: NGV
• UDI-Device Identifier: 00191506004637
• UDI-Public: (01)00191506004637(17)280614(10)36760285
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M635WU60400
• Device Catalogue Number: M635WU60400
• Device Lot Number: 0036760285
• 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: 09/14/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 09/17/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 06/15/2025
• 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: Other
• Patient Age: 70 YR
• Patient Sex: Male