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 Code	Stroke/CVA (1770)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Event or Problem Description
(b)(6) study.It was reported that a cerebral vascular accident (cva) occurred.A left atrial appendage (laa) closure procedure was performed and a 27mm watchman laa closure device was implanted.On (b)(6) 2021, 782 days post index procedure, the patient was noted with the chief complaint of right face weakness and the inability to speak.The patient's health condition continued to decline even after all the medical treatment and noted with fluctuation in the mental status.A stroke code was called.The patient was not a good candidate for tpa due to active gastrointestinal bleeding and was also not a candidate for mechanical thrombectomy due to physical medical condition.The neurologist was consulted, and it was suspected that the patient had suffered a left mca territory stroke and suffered multiple strokes in both hemispheres but that remained to be determined.The neurologist suspected the event was possibly related to large vessel atherosclerotic disease or some other mechanism.The initial computed tomography (ct) scan of the head without contrast was unremarkable for acute intracranial process and mild atrophy with moderate white matter disease.The neurologist recommended to undergo ct scan of the brain to determine the etiology of the stroke, transesophageal echo, carotid ultrasound, if possible, mri since the patient had a pacemaker and advised to continue on cardiac telemetry.The duration of focal or global neurological deficit was less than 24 hours in case of imaging-documented new hemorrhage or infarct.On (b)(6) 2021, 783 days post index procedure, the patient died due to shock.As per the death certificate, the immediate cause of death was asystole and sequential cause of death was infection.No autopsy was performed.

• 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
• MDR Report Key: 12597851
• Report Number: 2134265-2021-12588
• Device Sequence Number: 11606352
• Product Code: NGV
• UDI-Device Identifier: 08714729838241
• UDI-Public: 08714729838241
• Combination Product (Y/N): N
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2021

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: 03/27/2021
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0021925116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/08/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR