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	Transient Ischemic Attack (2109)
Date of Event	08/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: the event date was not reported so the aware date was used as an estimate.
Event or Problem Description
It was reported that the patient experienced a transient ischemic attack (tia).A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 24mm watchman laa closure device & delivery system (wds) were used.The procedure went as planned and was successfully completed with a closure device implanted in the laa of the patient.There were no complications that were reported to have occurred.25 months post procedure the patient had a tia.It was noted that the patient has carotid disease and the tia is believed to be related to that per the physician.The patient was on plavix and low dose aspirin at the time of 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
• MDR Report Key: 12417966
• Report Number: 2134265-2021-11154
• Device Sequence Number: 4724277
• Product Code: NGV
• UDI-Device Identifier: 08714729838234
• UDI-Public: 08714729838234
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

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: 04/30/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0023726232
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 09/02/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other