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	Stroke/CVA (1770)
Date of Event	04/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a cerebral vascular accident (cva) occurred.On (b)(6) 2020, a left atrial appendage (laa) closure procedure was performed and a 30mm watchman laa closure device was implanted with no residual leak.A transesophageal echo (tee) scheduled for (b)(6) 2020 was cancelled due to covid.The patient was advised to stop coumadin and start dual antiplatelet therapy (dapt).On (b)(6) 2020, the patient presented to the emergency room with a cva.Coumadin was restarted at this time.No intervention was done as the patient presented to emergency room greater than 5 hours after the onset of symptoms.A coronary computed tomography angiogram (cta) on (b)(6) 2020 revealed a leak along the lateral inferior aspect of the watchman device and thrombus external to the watchman anterior superior aspect.A cta performed on (b)(6) 2020 showed no device related thrombus.The patient was called and advised to stop coumadin and restart dapt.A tee performed on (b)(6) 2020 showed no device related thrombus, but a 5-6mm gap around the device was noted.On (b)(6) 2020 the patient was called and advised to stop coumadin.The patient was very hesitant to do this.During the 1-year follow-up call on 22jan2021, the patient remained on coumadin.The patient has an office visit on (b)(6) 2021 for further discussion.The patient is fully recovered except for some left foot drop.

• 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: 11617023
• Report Number: 2134265-2021-03975
• Device Sequence Number: 3668179
• 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,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2021

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: 11/28/2021
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0023009064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 04/05/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR