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); Facial Paralysis (4585)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported via clinical study.It was reported that the patient experienced a cerebral vascular accident (cva).A left atrial appendage (laa) closure procedure was performed.On (b)(6) 2022 the patient underwent successful placement of a 27 mm watchman flx device with complete laa seal and deployed device diameter of 22 mm.On (b)(6) 2022, the patient was discharged on aspirin (81 mg /day) and clopidogrel (75 mg/day).On (b)(6) 2025, 1002 days post index procedure, the patient presented to emergency room (er) with complaints of left face-sided weakness, facial droop, and loss of sensation.A computed tomography (ct) scan of the brain was performed for further evaluation.Additionally, venous duplex ultrasound, x-ray and laboratory tests were also performed.At the time of the event, the patient was on aspirin (81 mg /day).It was reported the event of a cva occurred.On the same day, national institutes of health stroke scale (nihss) was performed, and the score was noted to be 12.On (b)(6) 2025, modified rankin scale (mrs) was performed, and the score was noted to be 0 with no symptoms.On (b)(6) 2025, aspirin was stopped, and the patient was started with apixaban (10 mg/day) for stroke.On (b)(6) 2025, laa imaging via ct assessment revealed complete laa seal.There was no evidence of thrombus on the atrial facing surface of the watchman flx device and in the left atrium.No pericardial effusion and residual atrial septal shunt were noted.On (b)(6) 2025, the outcome of the event was considered to be resolved with sequalae, and subject was discharged on the same day.
Additional Manufacturer Narrative
B5 describe event or problem: updated with additional information received.H6: impact code added.
Event or Problem Description
Reported via clinical study.It was reported that the patient experienced a cerebral vascular accident (cva).A left atrial appendage (laa) closure procedure was performed.On (b)(6) 2022 the patient underwent successful placement of a 27 mm watchman flx device with complete laa seal and deployed device diameter of 22 mm.On (b)(6) 2022, the patient was discharged on aspirin (81 mg /day) and clopidogrel (75 mg/day).On (b)(6) 2025, 1002 days post index procedure, the patient presented to emergency room (er) with complaints of left face-sided weakness, facial droop, and loss of sensation.A computed tomography (ct) scan of the brain was performed for further evaluation.Additionally, venous duplex ultrasound, x-ray and laboratory tests were also performed.At the time of the event, the patient was on aspirin (81 mg /day).It was reported the event of a cva occurred.On the same day, national institutes of health stroke scale (nihss) was performed, and the score was noted to be 12.On (b)(6) 2025, modified rankin scale (mrs) was performed, and the score was noted to be 0 with no symptoms.On (b)(6) 2025, aspirin was stopped, and the patient was started with apixaban (10 mg/day) for stroke.On (b)(6) 2025, laa imaging via ct assessment revealed complete laa seal.There was no evidence of thrombus on the atrial facing surface of the watchman flx device and in the left atrium.No pericardial effusion and residual atrial septal shunt were noted.On (b)(6) 2025, the outcome of the event was considered to be resolved with sequalae, and subject was discharged on the same day.It was further reported that the patient was not able to say anything except his name.Upon physical examination the patient appeared well developed and nourished.Neuro check revealed 2/5 strength on left side with intermittently decreased sensation and severe to the left side, especially of the leg.Right side strength was noted as 5/5.A computed tomography angiography (cta) neck revealed diminutive left vertebral artery with suggestion of multifocal narrowing within the v2 and v3 segments.No hemodynamically significant stenosis was noted.On (b)(6) 2025, neurology was consulted, and it was noted that patient national institutes of health stroke scale (nihss) significantly improved to 1, with his left sided weakness resolved and patient was communicating normally.Per source, given the improvement in the patient condition, it was decided to hold tnk.Neurology recommended to initiate dual antiplatelet therapy (dapt) with aspirin (81 mg/day) and clopidogrel (75 mg/day) with a loading dose of 325 mg and 300mg.On (b)(6) 2025, the patient was admitted to neuro intensive care unit (icu) for q1 checks and perfusion measures and underwent placement of a central line.The patient was noted with neurologic worsening with concerns for rmca m2-m3 occlusion and ischemia to brain.An angiogram was recommended.On the same day the patient underwent diagnostic cerebral angiogram which revealed mid/distal right m2 inferior division occlusion with excellent collaterals.A repeat ct brain dated (b)(6) 2025, revealed expected evolution of acute posterior middle cerebral artery (mca) infraction with increased hypodensity and sulcal effacement at the right temporal pole.No hemorrhagic transformation was noted.Further, repeat ct brain perfusion revealed increased tmax in normal relative cerebral blood volume (rcbv) at the right temporal lobe, compatible with oligemia and stable appearance of focal occlusion of the right distal m1 segment and of multifocal occlusion of a right anterior proximal m2 branch.An ultrasound duplex carotid artery bilaterally revealed mild atherosclerotic plaque at the right carotid bulb.No hemodynamically significant stenoses was noted.On (b)(6) 2025, electrophysiology was consulted to reprogram the pacemaker for magnetic resonance imaging (mri).The patient underwent mri brain which revealed evolving acute infracts in the right mca territory involving caudate nucleus, insula, and large portion of the temporal lobe predominantly in the inferior m2 territory.Further the exam was aborted as patient became claustrophobic.On (b)(6) 2025, repeat ct brain revealed evolving acute right mca territory infract involving the right temporal lobe, insula and caudate head.Partial effacement of the right sylvian fissure was noted with no evidence of acute intracranial hemorrhage.In response to the event, clopidogrel was transitioned to cilostazol (100 mg/day).On (b)(6) 2025, aspirin was transitioned to apixaban (10 mg/day) for stroke.On (b)(6) 2025, modified rankin scale (mrs) was performed, and the score was noted to be 0.

• 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: 22844097
• Report Number: 2124215-2025-57972
• Device Sequence Number: 15772891
• Product Code: NGV
• UDI-Device Identifier: 08714729860501
• UDI-Public: (01)08714729860501(17)250427(10)29306554
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/04/2025

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: 04/27/2025
• Device Model Number: M635WU50270
• Device Catalogue Number: M635WU50270
• Device Lot Number: 0029306554
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 09/04/2025
• Date Device Manufactured: 04/28/2022
• 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
• Patient Age: 74 YR
• Patient Sex: Male