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 Codes	Dyspnea (1816); Dizziness (2194); Thrombosis/Thrombus (4440)
Date of Event	04/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a thrombosis occurred.A left atrial appendage (laa) closure procedure was performed and a 27mm watchman laa closure device was implanted on (b)(6) 2021.On (b)(6) 2021, the patient was admitted to an outside hospital with complaints of dizziness and shortness of breath.The patient was treated with antibiotics during this hospitalization.On (b)(6) 2021, the patient came in for a follow up appointment at the implanting facility, however, there was difficulty advancing the transesophageal echocardiography (tee) probe, so the procedure was aborted.The patient was tried again on (b)(6) 2021 with more anesthesia.A thrombus was seen via tee on the surface of the watchman closure device as there was evidence of a hyperechoic area of 1.9 x 1.0 cm with friability along this surface.There was no evidence of thrombus in the left atrium or the left atrial appendage.The patient was on xarelto 15mg prior to the procedure, but was switched over to warfarin 6mg.The patient was stable and scheduled for additional tee in 6 weeks for follow up.

• 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: 11933772
• Report Number: 2134265-2021-06459
• Device Sequence Number: 19791078
• Product Code: NGV
• UDI-Device Identifier: 08714729838241
• UDI-Public: 08714729838241
• 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: 2021
• 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): 06/03/2021

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: 03/23/2023
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0025389694
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 06/03/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR