MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN LAA CLOSURE DEVICE AND DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	10371
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Event or Problem Description
The patient was enrolled in the (b)(6) clinical study on (b)(6) 2020 with patient identifier rd (b)(6).It was reported that the closure device did not seal.Medical history: at the time of enrollment, the subject had a medical history of paroxysmal atrial fibrillation for greater than one year and cha2ds2-vasc score of 3, hyperlipidemia, atrial fibrillation ablation using the cyro technique (most recent: (b)(6) 2017), coronary artery disease, mitral valve regurgitation (tissue valve), tricuspid valve regurgitation (tissue valve), pulmonary valve regurgitation (tissue valve) and seizures.Procedure summary: prior to the index procedure, aspirin was administered.A 30 mm watchman left atrial appendage (laa) closure device (lot# 25135645) was attempted to be used but was not successful due to release criteria not met (position-too distal), anchor (stability) and seal.The subject then underwent successful placement of a 27 mm watchman laa closure device (lot# 25203490) with complete laa seal and deployed device diameter of 19.3mm.After the implant procedure, the subject was started on aspirin and clopidogrel.The subject was discharged one day post index procedure.Post procedure event summary: on the 3 months follow up dated (b)(6) 2021 revealed a largest residual jet around device size 4.5mm.On (b)(6) 2021, 380 days index procedure, at the 12 month follow up visit, transesophageal echocardiography (tee) revealed jet size around the device of 5.1 mm associated with leak in front of a coronary sinus or vein with flow.No action was taken for the event.At the time of reporting the event was considered ongoing.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE AND 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: 12488323
• Report Number: 2134265-2021-11742
• Device Sequence Number: 11600450
• Product Code: NGV
• UDI-Device Identifier: 08714729838241
• UDI-Public: 08714729838241
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2021

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: 02/12/2023
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0025203490
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/17/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR