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	Stroke/CVA (1770); Thrombosis/Thrombus (4440)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a thrombosis and cerebral vascular accident (cva) occurred.A left atrial appendage (laa) closure procedure was performed and a 30mm watchman laa closure device was implanted.At the 45 day follow up appointment on (b)(6) 2020, the transesophageal echocardiography (tee) noted that the closure device still met implant criteria.The patient was then taken off eliquis and placed on plavix and aspirin on (b)(6) 2020.The patient presented to the hospital for nose bleed on (b)(6) 2021 and (b)(6) 2021.Plavix was then discontinued on (b)(6) 2021 and the aspirin dose was increased to 325mg.On (b)(6) 2021, the patient presented to the hospital with a left temporal cva.Tee also found thrombus on the closure device.There was no intervention performed for the stroke nor for retrieval of the clot as the patient was not a candidate for tissue plasminogen activator treatment.Follow up was again performed on 19may2021 and the patient was overall doing well with some residual speech difficulty.The patient returned back at the nursing home they were previously residing from.

• 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: 12122011
• Report Number: 2134265-2021-07839
• Device Sequence Number: 4777190
• Product Code: NGV
• UDI-Device Identifier: 08714729838258
• UDI-Public: 08714729838258
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2021

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: 11/20/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0024806879
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 07/06/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR