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

Model Number	10371
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Thrombosis/Thrombus (4440)
Date of Event	05/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id: (b)(6).
Event or Problem Description
(b)(6) study.It was reported that a cerebral vascular accident (cva) and thrombosis occurred.The patient was on aspirin prior to the index procedure.On (b)(6) 2020, a left atrial appendage (laa) closure procedure was performed and a 24mm watchman laa closure device was implanted with a complete laa seal and deployed device diameter of 21mm.After the implant, the patient was started on clopidogrel.The post implant transesophageal echocardiogram (tee) revealed a complete laa seal.The patient was discharged on (b)(6) 2020.On (b)(6) 2021, 319 days post index procedure, the patient was diagnosed with a stroke.The patient was on aspirin and clopidogrel at the time of the event.The duration of focal or global neurological deficit was greater than 24 hours in the of imaging-documented new hemorrhage or infarct.On (b)(6) 2021, the national institutes of health (nih) stroke scale was 1.The baseline nih stroke scale that was performed on (b)(6) 2020 was 0.On (b)(6) 2021, 321 days post index procedure, the patient presented to the enrolling site for a 12 month follow up, which revealed thrombus on the device and worsened leak of 4mm around the watchman device.
Event or Problem Description
Asap too study.It was reported that a cerebral vascular accident (cva) and thrombosis occurred.The patient was on aspirin prior to the index procedure.On (b)(6) 2020, a left atrial appendage (laa) closure procedure was performed and a 24mm watchman laa closure device was implanted with a complete laa seal and deployed device diameter of 21mm.After the implant, the patient was started on clopidogrel.The post implant transesophageal echocardiogram (tee) revealed a complete laa seal.The patient was discharged on (b)(6) 2020.On (b)(6) 2021, 319 days post index procedure, the patient was diagnosed with a stroke.The patient was on aspirin and clopidogrel at the time of the event.The duration of focal or global neurological deficit was greater than 24 hours in the of imaging-documented new hemorrhage or infarct.On (b)(6) 2021, the national institutes of health (nih) stroke scale was 1.The baseline nih stroke scale that was performed on (b)(6) 2020 was 0.On (b)(6) 2021, 321 days post index procedure, the patient presented to the enrolling site for a 12 month follow up, which revealed thrombus on the device and worsened leak of 4mm around the watchman device.It was further reported that the patient presented to the emergency department on (b)(6) 2021 with aphasia suspicious to stroke and the patient was thus admitted by neurology.On the same day, magnetic resonance imaging (mri) revealed patchy foci of diffusion restriction and corresponding t2 flair hyperintensity seen in the left frontal temporal parenchyma with additional tiny recent infarcts in the right frontal lobe and right cerebellum in addition to small vessel disease, old infarcts, and volume loss.The thrombus was on the atrial facing surface of the closure device and was 10 x 6mm in size.The thrombus was identified via tee.The patient was started on plavix and eliquis.The patient was stable and discharged home on (b)(6) 2021.
Additional Manufacturer Narrative
A1: patient id - (b)(6).
Additional Manufacturer Narrative
A1: patient id: (b)(6).
Event or Problem Description
Asap too study.It was reported that a cerebral vascular accident (cva) and thrombosis occurred.The patient was on aspirin prior to the index procedure.On (b)(6) 2020, a left atrial appendage (laa) closure procedure was performed and a 24mm watchman laa closure device was implanted with a complete laa seal and deployed device diameter of 21mm.After the implant, the patient was started on clopidogrel.The post implant transesophageal echocardiogram (tee) revealed a complete laa seal.The patient was discharged on (b)(6) 2020.On (b)(6) 2021, 319 days post index procedure, the patient was diagnosed with a stroke.The patient was on aspirin and clopidogrel at the time of the event.The duration of focal or global neurological deficit was greater than 24 hours in the of imaging-documented new hemorrhage or infarct.On (b)(6) 2021, the national institutes of health (nih) stroke scale was 1.The baseline nih stroke scale that was performed on (b)(6) 2020 was 0.On (b)(6) 2021, 321 days post index procedure, the patient presented to the enrolling site for a 12 month follow up, which revealed thrombus on the device and worsened leak of 4mm around the watchman device.It was further reported that the patient presented to the emergency department on (b)(6) 2021 with aphasia suspicious to stroke and the patient was thus admitted by neurology.On the same day, magnetic resonance imaging (mri) revealed patchy foci of diffusion restriction and corresponding t2 flair hyperintensity seen in the left frontal temporal parenchyma with additional tiny recent infarcts in the right frontal lobe and right cerebellum in addition to small vessel disease, old infarcts, and volume loss.The thrombus was on the atrial facing surface of the closure device and was 10 x 6mm in size.The thrombus was identified via tee.The patient was started on plavix and eliquis.The patient was stable and discharged home on (b)(6) 2021.
Event or Problem Description
Asap too study.It was reported that a cerebral vascular accident (cva) and thrombosis occurred.The patient was on aspirin prior to the index procedure.On (b)(6) 2020, a left atrial appendage (laa) closure procedure was performed and a 24mm watchman laa closure device was implanted with a complete laa seal and deployed device diameter of 21mm.After the implant, the patient was started on clopidogrel.The post implant transesophageal echocardiogram (tee) revealed a complete laa seal.The patient was discharged on (b)(6) 2020.On (b)(6) 2021, 319 days post index procedure, the patient was diagnosed with a stroke.The patient was on aspirin and clopidogrel at the time of the event.The duration of focal or global neurological deficit was greater than 24 hours in the of imaging-documented new hemorrhage or infarct.On (b)(6) 2021, the national institutes of health (nih) stroke scale was 1.The baseline nih stroke scale that was performed on (b)(6) 2020 was 0.On (b)(6) 2021, 321 days post index procedure, the patient presented to the enrolling site for a 12 month follow up, which revealed thrombus on the device and worsened leak of 4mm around the watchman device.It was further reported that the patient presented to the emergency department on (b)(6) 2021 with aphasia suspicious to stroke and the patient was thus admitted by neurology.On the same day, magnetic resonance imaging (mri) revealed patchy foci of diffusion restriction and corresponding t2 flair hyperintensity seen in the left frontal temporal parenchyma with additional tiny recent infarcts in the right frontal lobe and right cerebellum in addition to small vessel disease, old infarcts, and volume loss.The thrombus was on the atrial facing surface of the closure device and was 10 x 6mm in size.The thrombus was identified via tee.The patient was started on plavix and eliquis.The patient was stable and discharged home on (b)(6) 2021.
Additional Manufacturer Narrative
B6: relevant tests/laboratory data- updated.B7: other relevant history - updated.
Event or Problem Description
Asap too study.It was reported that a cerebral vascular accident (cva) and thrombosis occurred.The patient was on aspirin prior to the index procedure.On (b)(6) 2020, a left atrial appendage (laa) closure procedure was performed and a 24mm watchman laa closure device was implanted with a complete laa seal and deployed device diameter of 21mm.After the implant, the patient was started on clopidogrel.The post implant transesophageal echocardiogram (tee) revealed a complete laa seal.The patient was discharged on (b)(6) 2020.On (b)(6) 2021, 319 days post index procedure, the patient was diagnosed with a stroke.The patient was on aspirin and clopidogrel at the time of the event.The duration of focal or global neurological deficit was greater than 24 hours in the of imaging-documented new hemorrhage or infarct.On (b)(6) 2021, the national institutes of health (nih) stroke scale was 1.The baseline nih stroke scale that was performed on (b)(6) 2020 was 0.On (b)(6) 2021, 321 days post index procedure, the patient presented to the enrolling site for a 12 month follow up, which revealed thrombus on the device and worsened leak of 4mm around the watchman device.It was further reported that the patient presented to the emergency department on (b)(6) 2021 with aphasia suspicious to stroke and the patient was thus admitted by neurology.On the same day, magnetic resonance imaging (mri) revealed patchy foci of diffusion restriction and corresponding t2 flair hyperintensity seen in the left frontal temporal parenchyma with additional tiny recent infarcts in the right frontal lobe and right cerebellum in addition to small vessel disease, old infarcts, and volume loss.The thrombus was on the atrial facing surface of the closure device and was 10 x 6mm in size.The thrombus was identified via tee.The patient was started on plavix and eliquis.The patient was stable and discharged home on (b)(6) 2021.It was further reported that computed tomography (ct) of the head was performed which revealed findings of chronic small vessel ischemic changes and no acute intracranial abnormality.On the same day, ct of the head and neck was also performed which revealed no evidence of carotid stenosis, both vertebral arteries are widely patent to the level of basilar, no evidence of focal filing defect or abrupt cut off to suggest acute central circle of willis large vessel occlusion and 7 mm indeterminate nodule left apex incidentally noted.A 7 mm indeterminate nodule left lung apex was also noted.
Event or Problem Description
Asap too study.It was reported that a cerebral vascular accident (cva) and thrombosis occurred.The patient was on aspirin prior to the index procedure.On (b)(6) 2020, a left atrial appendage (laa) closure procedure was performed and a 24mm watchman laa closure device was implanted with a complete laa seal and deployed device diameter of 21mm.After the implant, the patient was started on clopidogrel.The post implant transesophageal echocardiogram (tee) revealed a complete laa seal.The patient was discharged on (b)(6) 2020.On (b)(6) 2021, 319 days post index procedure, the patient was diagnosed with a stroke.The patient was on aspirin and clopidogrel at the time of the event.The duration of focal or global neurological deficit was greater than 24 hours in the of imaging-documented new hemorrhage or infarct.On (b)(6) 2021, the national institutes of health (nih) stroke scale was 1.The baseline nih stroke scale that was performed on (b)(6) 2020 was 0.On (b)(6) 2021, 321 days post index procedure, the patient presented to the enrolling site for a 12 month follow up, which revealed thrombus on the device and worsened leak of 4mm around the watchman device.It was further reported that the patient presented to the emergency department on (b)(6) 2021 with aphasia suspicious to stroke and the patient was thus admitted by neurology.On the same day, magnetic resonance imaging (mri) revealed patchy foci of diffusion restriction and corresponding t2 flair hyperintensity seen in the left frontal temporal parenchyma with additional tiny recent infarcts in the right frontal lobe and right cerebellum in addition to small vessel disease, old infarcts, and volume loss.The thrombus was on the atrial facing surface of the closure device and was 10 x 6mm in size.The thrombus was identified via tee.The patient was started on plavix and eliquis.The patient was stable and discharged home on (b)(6) 2021.It was further reported that computed tomography (ct) of the head was performed which revealed findings of chronic small vessel ischemic changes and no acute intracranial abnormality.On the same day, ct of the head and neck was also performed which revealed no evidence of carotid stenosis, both vertebral arteries are widely patent to the level of basilar, no evidence of focal filing defect or abrupt cut off to suggest acute central circle of willis large vessel occlusion and 7 mm indeterminate nodule left apex incidentally noted.A 7 mm indeterminate nodule left lung apex was also noted.It was further reported that though the site did not downgrade the causality of the thrombus, the thrombus was confirmed via imaging to not be on the atrial facing side of the closure device.Thus, the closure device was performing as intended.
Additional Manufacturer Narrative
A1: patient id - (b)(6).B5: describe event or problem - updated.H6: patient codes- updated.H6: impact codes- updated.
Additional Manufacturer Narrative
A1: patient id - (b)(6).
Event or Problem Description
Asap too study.It was reported that a cerebral vascular accident (cva) and thrombosis occurred.The patient was on aspirin prior to the index procedure.On (b)(6) 2020, a left atrial appendage (laa) closure procedure was performed and a 24mm watchman laa closure device was implanted with a complete laa seal and deployed device diameter of 21mm.After the implant, the patient was started on clopidogrel.The post implant transesophageal echocardiogram (tee) revealed a complete laa seal.The patient was discharged on (b)(6) 2020.On (b)(6) 2021, 319 days post index procedure, the patient was diagnosed with a stroke.The patient was on aspirin and clopidogrel at the time of the event.The duration of focal or global neurological deficit was greater than 24 hours in the of imaging-documented new hemorrhage or infarct.On (b)(6) 2021, the national institutes of health (nih) stroke scale was 1.The baseline nih stroke scale that was performed on (b)(6) 2020 was 0.On (b)(6) 2021, 321 days post index procedure, the patient presented to the enrolling site for a 12 month follow up, which revealed thrombus on the device and worsened leak of 4mm around the watchman device.It was further reported that the patient presented to the emergency department on (b)(6) 2021 with aphasia suspicious to stroke and the patient was thus admitted by neurology.On the same day, magnetic resonance imaging (mri) revealed patchy foci of diffusion restriction and corresponding t2 flair hyperintensity seen in the left frontal temporal parenchyma with additional tiny recent infarcts in the right frontal lobe and right cerebellum in addition to small vessel disease, old infarcts, and volume loss.The thrombus was on the atrial facing surface of the closure device and was 10 x 6mm in size.The thrombus was identified via tee.The patient was started on plavix and eliquis.The patient was stable and discharged home on (b)(6) 2021.It was further reported that computed tomography (ct) of the head was performed which revealed findings of chronic small vessel ischemic changes and no acute intracranial abnormality.On the same day, ct of the head and neck was also performed which revealed no evidence of carotid stenosis, both vertebral arteries are widely patent to the level of basilar, no evidence of focal filing defect or abrupt cut off to suggest acute central circle of willis large vessel occlusion and 7 mm indeterminate nodule left apex incidentally noted.A 7 mm indeterminate nodule left lung apex was also noted.It was further reported that though the site did not downgrade the causality of the thrombus, the thrombus was confirmed via imaging to not be on the atrial facing side of the closure device.Thus, the closure device was performing as intended.It was further reported that the causality of the thrombus was now downgraded by the site as the thrombus was confirmed via imaging to not be on the atrial facing side of the closure device and the closure device was performing as intended.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 11922782
• Report Number: 2134265-2021-06755
• Device Sequence Number: 16355699
• Product Code: NGV
• UDI-Device Identifier: 08714729838234
• UDI-Public: 08714729838234
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/06/2023

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: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0024778517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 06/03/2021; 08/10/2021; 07/07/2022; 11/30/2022; 01/04/2023; 01/05/2023
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 06/21/2021; 08/20/2021; 07/13/2022; 12/13/2022; 01/05/2023; 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Race: White