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	08/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was enrolled in the (b)(6) study on (b)(6) 2018 with patient identifier (b)(6).It was reported that cerebral vascular accident (cva) occurred.A left atrial appendage (laa) closure procedure was being performed.The patient underwent successful placement of a 33mm watchman laa closure device with a complete laa seal and deployed device diameter of 27.6mm.Prior to index procedure, aspirin was administered.After implant, the patient was started on aspirin and clopidogrel.The patient was discharged the following day.Seven hundred and sixty-six days post-index procedure, the patient presented emergently with left-sided facial droop and dysarthria.At this time that patient was not on any anticoagulants.The patient was hospitalized and upon admission was noted to experience speech disturbance, knowledge deficit, and mobility impairment.Two days later, computed tomography was performed and negative for infarct.Magnetic resonance imaging (mri) angiography of the head was performed revealing normal intracranial images.The same day mri of the brain was performed revealing one slice phenomena of subtle restricted diffusion in the right basal ganglion which may or may not reflect an acute infarct.However, no hemorrhage or mass effect and no diffusion was noted.The same day carotid artery scan bilateral duplex revealed 41-59% stenosis of the proximal right intracranial carotid artery.The patient was diagnosed with acute ischemic cva.The patient was started on plavix and aspirin.Three days after admission to the hospital the patient was noted with improved condition.The event was considered resolved and the patient was discharged home.

• 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: 13685966
• Report Number: 2134265-2022-02485
• Device Sequence Number: 1944412
• Product Code: NGV
• UDI-Device Identifier: 08714729838265
• UDI-Public: 08714729838265
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 03/07/2022

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: 03/09/2020
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0020386422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Male