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

Model Number	M635WU50240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Transient Ischemic Attack (2109); Confusion/ Disorientation (2553)
Date of Event	06/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported via clinical study.It was reported that a transient ischemic attack (tia) occurred.On (b)(6) 2022, the patient underwent a left atrial appendage (laa) closure procedure with successful placement of a 24 mm watchman flx closure device with a deployed device diameter of 18.1 mm.The patient was discharged the same day on apixaban (10 mg/day) and aspirin (81 mg/day).On (b)(6) 2022, 94 days post index procedure, the patient presented to the emergency room (er) with sudden onset of confusion and got diagnosed with transient global amnesia (tga).The patient was on aspirin (81 mg /day) at the time of the event.The patient was admitted to the hospital for further evaluation.The next day, magnetic resonance imaging (mri) of the brain was performed which resulted without any evidence of ischemia.The event was classified as tia.On (b)(6) 2022, the event was considered to be resolved.The patient remained stable and was discharged home on aspirin (81 mg/day).
Event or Problem Description
Reported via clinical study it was reported that a transient ischemic attack (tia) occurred.On (b)(6) 2022, the patient underwent a left atrial appendage (laa) closure procedure with successful placement of a 24 mm watchman flx closure device with a deployed device diameter of 18.1 mm.The patient was discharged the same day on apixaban (10 mg/day) and aspirin (81 mg/day).On (b)(6) 2022, 94 days post index procedure, the patient presented to the emergency room (er) with sudden onset of confusion and got diagnosed with transient global amnesia (tga).The patient was on aspirin (81 mg /day) at the time of the event.The patient was admitted to the hospital for further evaluation.The next day, magnetic resonance imaging (mri) of the brain was performed which resulted without any evidence of ischemia.The event was classified as tia.On (b)(6) 2022, the event was considered to be resolved.The patient remained stable and was discharged home on aspirin (81 mg/day).
Additional Manufacturer Narrative
With all the available information, boston scientific (bsc) concludes: device technical analysis the watchman flx? remains implanted; therefore, returned device analysis could not be completed.Device history record review a review was completed of the device history records (dhr) for the watchman flx?, part # m635wu50240 batch # 0028911981.The device was processed through all normal operational conditions and passed all acceptance activities.The dhr review did not identify any deviations or non-conformances that could have contributed to the event.Labeling review there was no evidence to suggest that the device was used in a manner inconsistent with the labeling.Watchman flx? instructions for use (ifu) lists potential complications, risks and adverse events that may be associated with the use of this device which include transient ischemic attack (tia) (confusion) (hospitalization, imaging required).Risk review a risk review was completed and confirmed that the event of transient ischemic attack (tia) (confusion) was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.

• 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: 24533241
• Report Number: 2124215-2026-12596
• Device Sequence Number: 9070844
• Product Code: NGV
• UDI-Device Identifier: 08714729860495
• UDI-Public: (01)08714729860495(17)250220(10)28911981
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/20/2025
• Device Model Number: M635WU50240
• Device Catalogue Number: M635WU50240
• Device Lot Number: 0028911981
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/07/2026
• Date Device Manufactured: 02/21/2022
• 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; Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Race: White