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 Codes	Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event is an approximate date as the actual event date is not known.
Event or Problem Description
Reported via patient call center.It was reported that a device leak occurred.A left atrial appendage (laa) closure procedure was performed, and a 35mm watchman flx pro closure device was successfully implanted on (b)(6) 2023.The patient was discharged.The patient stated that has a leak and that the physicians attempted to fix the leak.The patient stated that was told the tissue did not grow over the leak, it was a slight leak, and that the repair failed.The patient still on eliquis, and stated the physicians mentioned another possible repair the patient also stated that would like to get off his blood thinner.
Additional Manufacturer Narrative
B3: date of event updated with additional information received.B5 describe event or problem: updated with additional information received.H6 patient code updated from e2403 no clinical signs, symptoms or conditions to e0514 thrombosis/thrombus.H6 impact code f2301 additional device required added.
Event or Problem Description
Reported via patient call center.It was reported that a device leak occurred.A left atrial appendage (laa) closure procedure was performed, and a 35mm watchman flx pro closure device was successfully implanted on (b)(6) 2023.The patient was discharged.The patient stated that has a leak and that the physicians attempted to fix the leak.The patient stated that was told the tissue did not grow over the leak, it was a slight leak, and that the repair failed.The patient still on eliquis and stated the physicians mentioned another possible repair the patient also stated that would like to get off his blood thinner.It was further reported that a 2.7mm x 1.5mm thrombus was noted on transesophageal echocardiography (tee) and the size of the leak was 5mm.A non-boston scientific (bsc) duct occluder was used to close the leak on (b)(6)2024.A tee performed on (b)(6) 2025 showed the leak around the duct occluder to be 2.1mm.Another tee performed on (b)(6) 2025 showed the leak around the duct occluder to be 1.3mm.The decision was made to discontinue oral anticoagulation.

• 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: 22841864
• Report Number: 2124215-2025-57942
• Device Sequence Number: 17349098
• Product Code: NGV
• UDI-Device Identifier: 08714729860525
• UDI-Public: (01)08714729860525(17)250322(10)29090596
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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 Expiration Date: 03/22/2025
• Device Model Number: M635WU50350
• Device Catalogue Number: M635WU50350
• Device Lot Number: 0029090596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 09/03/2025
• Date Device Manufactured: 03/23/2022
• 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: Other; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male