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); Headache (1880)
Date of Event	07/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier - (b)(6).
Event or Problem Description
(b)(4).Study.It was reported that a cerebral vascular accident (cva) occurred.The patient was enrolled into the (b)(4) study on (b)(6) 2018, and the procedure was performed sixty one (61) days later.A 27mm watchman left atrial appendage (laa) closure device was implanted with a complete laa seal and deployed device diameter of 22.7mm.The patient was started on aspirin and clopidogrel following the procedure.The patient was discharged one day post index procedure.The patient presented to the hospital one thousand twenty one (1021) days post index procedure due to a headache.The patient allegedly experienced the symptoms four days prior to admission on (b)(6) 2021.Physical examination revealed moderate headache in the left parietal and left temporal region.The patient was hospitalized for further evaluation and treatment on the same day.Seven days after admission for a headache, a computed tomography (ct) scan of the head without intravenous (iv) contrast revealed no acute intracranial hemorrhage.A large area of low attenuation at the left temporal lobe and posterior aspect of the left parietal lobe was potential representative of an acute or subacute infarct.An enhancing mass due to iv contrast could not be ruled out, therefore, further ct scan or magnetic resonance imaging (mri) was recommended for the patient.The patient was diagnosed with a stroke.The etiology of the stroke was undetermined for which the duration of the focal or global neurological deficit was greater than 24 hours.On the same day of the ct scan, the patient was noted in improved condition and the patient was discharged home on the same day.Two days post discharge, a repeat ct scan of the head with iv contrast revealed no change in the large attenuation at the left temporal lobe or left parietal lobe.A small low attenuation in the left occipital lobe was also noted which represented subacute or acute infract without enhancing mass after iv contrast administration.On the same day, a ct angiogram of the brain with iv contrast revealed focal stenosis of the proximal aspect of the right posterior cerebral artery.Limited visualization of distal aspect of bilateral posterior cerebral arteries.No aneurysm dilation was noted.Atherosclerosis vascular disease of the cavernous portion of the bilateral internal carotid arteries with stenosis was also noted.
Additional Manufacturer Narrative
B5: describe event or problem - updated.B6: relevant tests/laboratory data- updated.
Event or Problem Description
Asap-too study.It was reported that a cerebral vascular accident (cva) occurred.The patient was enrolled into the asap-too study on (b)(6) 2018, and the procedure was performed sixty one (61) days later.A 27mm watchman left atrial appendage (laa) closure device was implanted with a complete laa seal and deployed device diameter of 22.7mm.The patient was started on aspirin and clopidogrel following the procedure.The patient was discharged one day post index procedure.The patient presented to the hospital one thousand twenty one (1021) days post index procedure due to a headache.The patient allegedly experienced the symptoms four days prior to admission on (b)(6) 2021.Physical examination revealed moderate headache in the left parietal and left temporal region.The patient was hospitalized for further evaluation and treatment on the same day.Seven days after admission for a headache, a computed tomography (ct) scan of the head without intravenous (iv) contrast revealed no acute intracranial hemorrhage.A large area of low attenuation at the left temporal lobe and posterior aspect of the left parietal lobe was potential representative of an acute or subacute infarct.An enhancing mass due to iv contrast could not be ruled out, therefore, further ct scan or magnetic resonance imaging (mri) was recommended for the patient.The patient was diagnosed with a stroke.The etiology of the stroke was undetermined for which the duration of the focal or global neurological deficit was greater than 24 hours.On the same day of the ct scan, the patient was noted in improved condition and the patient was discharged home on the same day.Two days post discharge, a repeat ct scan of the head with iv contrast revealed no change in the large attenuation at the left temporal lobe or left parietal lobe.A small low attenuation in the left occipital lobe was also noted which represented subacute or acute infract without enhancing mass after iv contrast administration.On the same day, a ct angiogram of the brain with iv contrast revealed focal stenosis of the proximal aspect of the right posterior cerebral artery.Limited visualization of distal aspect of bilateral posterior cerebral arteries.No aneurysm dilation was noted.Atherosclerosis vascular disease of the cavernous portion of the bilateral internal carotid arteries with stenosis was also noted.It was further reported that the patient presented to the hospital 1024 days post procedure as opposed to 1021 days previously reported with the previously reported symptoms four days prior.Magnetic resonance imaging (mri) was not performed for diagnosis.Following the stroke diagnosis, no action was taken in response to the event.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13999369
• Report Number: 2134265-2022-03459
• Device Sequence Number: 20060710
• Product Code: NGV
• UDI-Device Identifier: 08714729838241
• UDI-Public: 08714729838241
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 04/12/2022

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: 07/10/2021
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0022363055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2018
• 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; Hospitalization
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Race: White