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	Stroke/CVA (1770); Dysphasia (2195); Shaking/Tremors (2515); Cognitive Changes (2551); Balance Problems (4401); Movement Disorder (4412)
Date of Event	07/31/2024
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.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) and a 24mm watchman flx laa closure device & delivery system (wds) were selected to be used.The procedure was successfully completed with the closure device implanted with a laa complete seal and deployed device diameter of 19.0 mm.There were no patient complications that were reported to have occurred.The patient was discharged on aspirin (81 mg /day) and apixaban (10 mg/day).Two years post procedure the patient had an office visit for cognitive and behavioral changes which was associated with symptoms of ataxia and tremor.The patients family was noticing changes in behavior, like being quieter less talkative and had a change in facial expressions and increased forgetfulness.Upon review of system, the patient showed musculoskeletal gait abnormality (shuffling) and hand tremors.Physical examination revealed gait shuffling and no other significant findings noted.The patient was further referred to neurology, for evaluation and management.Ten days later magnetic resonance imaging (mri) of brain revealed, small subacute left basal ganglia infarct.Few additional, old left basal ganglia infarct was also present.Mild-to-moderate global parenchymal volume loss (as compared to the left, suspect mild preferential volume loss of the right hippocampus as compared to the left).Moderate chronic white matter changes.Heterogeneous appearance of the parotid glands.The patient was referred to neurology.Based on the diagnostic findings, the patient was diagnosed with a stroke.Three months later, aspirin was held, and aggrenox (25/200 mg twice/day) was started in response to the event.The patient had neurology consultation for sudden onset of problems with speech balance and abnormal brain mri.Upon neurological examination at that time was essentially unremarkable though the patient had diminished reflexes in legs with decreased sensation in feet, compatible with a diabetic peripheral neuropathy.Based on the findings, it was determined that the patient had a stroke, and the patient had a shower of emboli.The patient had been referred to another hospital for stroke since he seems to be getting better.Nine months later (three years post procedure) the outcome of the event was considered to be resolved.
Additional Manufacturer Narrative
H6 patient codes: e0107 cognitive changes & e0122 movement disorder added.
Event or Problem Description
Reported via clinical study.It was reported that the patient experienced a cerebral vascular accident.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) and a 24mm watchman flx laa closure device & delivery system (wds) were selected to be used.The procedure was successfully completed with the closure device implanted with a laa complete seal and deployed device diameter of 19.0 mm.There were no patient complications that were reported to have occurred.The patient was discharged on aspirin (81 mg /day) and apixaban (10 mg/day).Two years post procedure the patient had an office visit for cognitive and behavioral changes which was associated with symptoms of ataxia and tremor.The patients family was noticing changes in behavior, like being quieter less talkative and had a change in facial expressions and increased forgetfulness.Upon review of system, the patient showed musculoskeletal gait abnormality (shuffling) and hand tremors.Physical examination revealed gait shuffling and no other significant findings noted.The patient was further referred to neurology, for evaluation and management.Ten days later magnetic resonance imaging (mri) of brain revealed, small subacute left basal ganglia infarct.Few additional, old left basal ganglia infarct was also present.Mild-to-moderate global parenchymal volume loss (as compared to the left, suspect mild preferential volume loss of the right hippocampus as compared to the left).Moderate chronic white matter changes.Heterogeneous appearance of the parotid glands.The patient was referred to neurology.Based on the diagnostic findings, the patient was diagnosed with a stroke.Three months later, aspirin was held, and aggrenox (25/200 mg twice/day) was started in response to the event.The patient had neurology consultation for sudden onset of problems with speech balance and abnormal brain mri.Upon neurological examination at that time was essentially unremarkable though the patient had diminished reflexes in legs with decreased sensation in feet, compatible with a diabetic peripheral neuropathy.Based on the findings, it was determined that the patient had a stroke, and the patient had a shower of emboli.The patient had been referred to another hospital for stroke since he seems to be getting better.Nine months later (three years post procedure) the outcome of the event was considered to be resolved.

• 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: 23367932
• Report Number: 2124215-2025-75888
• Device Sequence Number: 8915732
• Product Code: NGV
• UDI-Device Identifier: 08714729860495
• UDI-Public: (01)08714729860495(17)250519(10)29440790
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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: 05/19/2025
• Device Model Number: M635WU50240
• Device Catalogue Number: M635WU50240
• Device Lot Number: 0029440790
• 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: 10/15/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 01/22/2026
• Date Device Manufactured: 05/20/2022
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White