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	12/14/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Asap too study.It was reported that thrombosis occurred.A left atrial appendage (laa) closure procedure was being performed.Prior to the index procedure, aspirin was administered and after the implant procedure the patient was started on clopidogrel, aspirin was continued.The patient underwent successful placement of a 24 mm watchman left atrial appendage (laa) closure device with complete laa seal and deployed device diameter of 17 mm.One day post index procedure, the patient was discharged.On (b)(6) 2017, 85 days post index procedure at the 3 month follow-up visit, transesophageal echocardiogram (tee) revealed a thrombus on the atrial facing surface of the device.Of note, during 3-month core lab tee follow-up visit the thrombus was noted, however, per site no thrombus was noted.The size of the maximum area of device thrombus 0.42 cm2 and the thrombus was non mobile.During this time, the patient was on aspirin and clopidogrel.On (b)(6) 2018, during the 12 month follow-up visit no thrombus was noted.

• 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: 13051695
• Report Number: 2134265-2021-16031
• Device Sequence Number: 3912916
• Product Code: NGV
• UDI-Device Identifier: 08714729838234
• UDI-Public: 08714729838234
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 12/21/2021

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: 02/09/2020
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0020270378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2017
• 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: 76 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White