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	Thrombosis/Thrombus (4440)
Date of Event	05/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event - estimated as it was reported that the tee was performed four weeks prior to the comment by the patient, which would be approximately (b)(6) 2021.
Event or Problem Description
It was reported that a thrombosis occurred.A left atrial appendage (laa) closure procedure was performed and a 24mm watchman laa closure device was implanted.Six months post index procedure, the patient had a small thrombus on the surface of the closure device.The patient was taken off their plavix regimen and was placed back on eliquis.The patient had another transesophageal echocardiography (tee) performed on (b)(6) 2021, which still showed thrombus on the device.The patient continued their eliquis drug regimen.

• 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: 12144360
• Report Number: 2134265-2021-08325
• Device Sequence Number: 19876306
• Product Code: NGV
• UDI-Device Identifier: 08714729838234
• UDI-Public: 08714729838234
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2021

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: 02/23/2023
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0025255454
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/09/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention