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	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that thrombosis and leak occurred.A left atrial appendage (laa) closure procedure was performed and a 33mm watchman laa closure device was implanted.Approximately two and a half years post index procedure, a large thrombus was seen on the face of the closure device via transesophageal echocardiography (tee) during a routine tee appointment for cardioversion.A leak was previously seen during the earlier 45-day follow-up tee, but is unknown if this was less than 5mm in size.However, during the follow-up approximately two and a half years later, the leak around the closure device towards the mitral valve grew larger than 5mm.The leak was observed towards the mitral side of the laa.The patient was started back on oral anticoagulants and will follow-up with a repeat tee in 2 months.
Additional Manufacturer Narrative
Date of event - estimated as (b)(6) 2022 as the event was reported as approximately two and a half years post procedure with the date of implant of (b)(6) 2019.

• 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: 13695855
• Report Number: 2134265-2022-02536
• Device Sequence Number: 3733335
• Product Code: NGV
• UDI-Device Identifier: 08714729838265
• UDI-Public: 08714729838265
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2022

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: 09/19/2021
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0022680734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2018
• 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: 84 YR
• Patient Sex: Female