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	01/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a cerebral vascular accident occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 30mm watchman laa closure device & delivery system (wds) were used.The device met release criteria and was released.Approximately 30 seconds after release, it was noted on echo that there was some unknown object swinging on the face of the device.This was seen in numerous echo views.The patient was taken off the table without any notable issues or interventions.Later that evening, the patient experienced aphasia.A magnetic resonance imaging (mri) was performed which confirmed the patient had a stroke.The patient remains in the hospital.

• 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: 11324184
• Report Number: 2134265-2021-01574
• Device Sequence Number: 4010750
• Product Code: NGV
• UDI-Device Identifier: 08714729838258
• UDI-Public: 08714729838258
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 02/12/2021

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: 12/19/2021
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0023110082
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 02/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other