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

Model Number	M635WU50270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Dysphagia/ Odynophagia (1815); Dysphasia (2195)
Date of Event	04/12/2026
Type of Reportable Event	Death
Event or Problem Description
Reported via clinical study.It was reported that the patient experienced a cerebral vascular accident and the patient died.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) and a 27mm watchman flx laa closure device & delivery system (wds) were selected to be used.The procedure was successfully completed with the closure device implanted in the laa of the patient.There were no patient complications that were reported to have occurred.Four (4) years post procedure the patient presented to the emergency room with new onset aphasia and rightward gaze deviation.Computed tomography (ct) of the brain/neck showed no acute intracranial abnormality, no large vessel occlusion, or high-grade stenosis.Magnetic resonance imaging (mri) showed an acute nonhemorrhagic l paramedian pontine infarct on the brain.There was no deep vein thrombosis, no leak or thrombosis on ct of the heart.The patient developed dysphagia.The patient's family decided on home hospice and the patient was discharged home five (5) days after presenting to the hospital.Eleven (11) days after the onset of this event the patient died.
Event or Problem Description
Reported via clinical study.It was reported that the patient experienced a cerebral vascular accident and the patient died.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) and a 27mm watchman flx laa closure device & delivery system (wds) were selected to be used.The procedure was successfully completed with the closure device implanted in the laa of the patient.There were no patient complications that were reported to have occurred.Four (4) years post procedure the patient presented to the emergency room with new onset aphasia and rightward gaze deviation.Computed tomography (ct) of the brain/neck showed no acute intracranial abnormality, no large vessel occlusion, or high-grade stenosis.Magnetic resonance imaging (mri) showed an acute nonhemorrhagic l paramedian pontine infarct on the brain.There was no deep vein thrombosis, no leak or thrombosis on ct of the heart.The patient developed dysphagia.The patient's family decided on home hospice and the patient was discharged home five (5) days after presenting to the hospital.Eleven (11) days after the onset of this event the patient died.
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 # m635wu50270 batch # 0028697409.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 cerebral vascular accident (cva) (dysphagia, dysphasia) and death (imaging required, hospitalization or prolonged hospitalization).Risk review: a risk review was completed and confirmed that the events of cerebral vascular accident (cva) (dysphagia, dysphasia) and death were defined in the risk documentation.These event types have 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 cause not established.

• 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 ; +1(651)242-2111
• MDR Report Key: 25505780
• Report Number: 2124215-2026-31762
• Device Sequence Number: 16076610
• Product Code: NGV
• UDI-Device Identifier: 08714729860501
• UDI-Public: (01)08714729860501(17)250117(10)28697409
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2026

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: 01/17/2025
• Device Model Number: M635WU50270
• Device Catalogue Number: M635WU50270
• Device Lot Number: 0028697409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Supplement Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 08/03/2026
• Date Device Manufactured: 01/18/2022
• 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; Death
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 122 LB