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

Model Number	M635WU50350
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 date of event: estimated as 06/25/2025 as the published date for the article is noted as 25 june 2025.D4 unique identifier (udi) #: detailed product information was not provided to bsc as this event was reported via a literature article.This event may represent a duplicate of an event which was already known to boston scientific.Because the product information is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Literature citation: dahou, a, tran, n, dal-bianco, j.Et al.(2025).Usefulness of echocardiography contrast agents for the detection of residual leak after percutaneous laa closure device implantation.J am coll cardiol case rep.Jun 30 (16).Https://doi.Org/10.1016/j.Jaccas.2025.104197.
Event or Problem Description
Reported via literature article.It was reported the device did not seal.Preprocedural transthoracic echocardiography (tte) showed a markedly enlarged left atrium (la), preserved left ventricular ejection fraction (69%), and mild mitral regurgitation.Transesophageal echocardiography (tee) showed no thrombus in the left atrial appendage (laa) or the la.The patient underwent percutaneous left atrial appendage closure (laac) through the implantation of a 35mm watchman flx closure device.Immediate postprocedural transesophageal echocardiography (tee) imaging showed a well-seated watchman device with no residual leak.A follow-up tee performed 10 weeks after device implantation was unremarkable, with no residual leak or thrombus, and anticoagulation therapy was stopped.Subsequent tee was performed 17 months after device implantation, due to abnormal gap around the device noted on cardiac computed tomography done for chest pain.Tee findings were suspicious for a residual leak by color doppler, but a definite diagnosis could not be made.An echo contrast agent was then used, which clearly showed a residual leak around the device located at the lateral aspect of the appendage (at 0 degrees), with opacification of a pouch-like area at the distal aspect of the laa underneath the watchman device, highlighting a communication between the laa and la.These findings helped establish a definite diagnosis of residual leak around the watchman device, which helped guide further management, with the decision to maintain anticoagulation and the consideration of potential percutaneous closure of the residual leak.After multidisciplinary discussion, the patient underwent successful closure of the residual leak with the implantation of coils and a non-boston scientific vascular plug.

• 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: 22593998
• Report Number: 2124215-2025-49504
• Device Sequence Number: 18391229
• Product Code: NGV
• UDI-Device Identifier: 08714729860525
• UDI-Public: (01)08714729860525
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2025

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: M635WU50350
• Device Catalogue Number: M635WU50350
• 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: 07/22/2025
• Initial Report FDA Received Date: 07/24/2025
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female