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

Model Number	M635WU24060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Transient Ischemic Attack (2109); Numbness (2415); Confusion/ Disorientation (2553); Speech Disorder (4415); Facial Paralysis (4585)
Date of Event	06/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported via clinical study: it was reported that the patient experienced a transient ischemic attack.A left atrial appendage (laa) closure procedure was performed.The patient underwent successful placement of a 24mm watchman left atrial appendage closure (laac) device with complete laa seal and deployed device diameter of 21mm.The patient was discharged on clopidogrel and aspirin on (b)(6) 2020.On (b)(6) 2025, 1809 days post index procedure, the patient presented to the emergency department with complaints of difficulty in finding words, confusion, feeling unwell and reported some vague numbness of lower extremity.In the emergency department, physical examination and review of system showed unremarkable changes.Additionally, a neurological examination revealed the patient to be alert.On the same day nih stroke scale was 3 and clinical examination revealed slight left sided facial droop, accompanied by mild aphasia and mild dysarthria.A computed tomography (ct) scan of the head without contrast was performed and revealed no acute intracranial abnormality.There was a small area of chronic prior infarction involving the left cerebellar hemisphere and the left frontal lobe.There was evidence of generalized cerebral atrophy and further observations also revealed chronic small vessel ischemic changes within the white matter.A ct angiography of the head and neck identified small area of ground-glass opacification within the left upper lung, non-specific, no evidence of hemodynamically significant stenosis or occlusion involving the major arteries of the head or neck.Based on the symptoms and diagnostic findings, the patient was diagnosed with transient ischemic attack (tia).An emergency room (er) evaluation was performed to treat the event.On (b)(6) 2025, the patient was reassessed, the neurological examination was normal, and the event was considered as resolved.Tissue plasminogen activator (tpa) was not administered as the patient was on blood thinner and has surpassed the treatment window.
Additional Manufacturer Narrative
H6: patient code added h6: impact code added.
Event or Problem Description
Reported via clinical study it was reported that the patient experienced a transient ischemic attack.A left atrial appendage (laa) closure procedure was performed.The patient underwent successful placement of a 24mm watchman left atrial appendage closure (laac) device with complete laa seal and deployed device diameter of 21mm.The patient was discharged on clopidogrel and aspirin on (b)(6) 2020.On (b)(6) 2025, 1809 days post index procedure, the patient presented to the emergency department with complaints of difficulty in finding words, confusion, feeling unwell and reported some vague numbness of lower extremity.In the emergency department, physical examination and review of system showed unremarkable changes.Additionally, a neurological examination revealed the patient to be alert.On the same day nih stroke scale was 3 and clinical examination revealed slight left sided facial droop, accompanied by mild aphasia and mild dysarthria.A computed tomography (ct) scan of the head without contrast was performed and revealed no acute intracranial abnormality.There was a small area of chronic prior infarction involving the left cerebellar hemisphere and the left frontal lobe.There was evidence of generalized cerebral atrophy and further observations also revealed chronic small vessel ischemic changes within the white matter.A ct angiography of the head and neck identified small area of ground-glass opacification within the left upper lung, non-specific, no evidence of hemodynamically significant stenosis or occlusion involving the major arteries of the head or neck.Based on the symptoms and diagnostic findings, the patient was diagnosed with transient ischemic attack (tia).An emergency room (er) evaluation was performed to treat the event.On (b)(6) 2025, the patient was reassessed, the neurological examination was normal, and the event was considered as resolved.Tissue plasminogen activator (tpa) was not administered as the patient was on blood thinner and has surpassed the treatment window.

• Brand Name: WATCHMAN
• 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: 22319644
• Report Number: 2124215-2025-41345
• Device Sequence Number: 21047285
• Product Code: NGV
• UDI-Device Identifier: 08714729838234
• UDI-Public: (01)08714729838234(17)221114(10)24778517
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 10/23/2025

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: 11/14/2022
• Device Model Number: M635WU24060
• Device Catalogue Number: M635WU24060
• Device Lot Number: 0024778517
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 10/23/2025
• Date Device Manufactured: 11/15/2019
• 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: 81 YR
• Patient Sex: Female
• Patient Race: White