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); Transient Ischemic Attack (2109); Thrombosis/Thrombus (4440)
Date of Event	12/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event and explant date: estimated based on the event occurring the following weekend after implant.
Event or Problem Description
It was reported that thrombosis and a cerebral vascular accident occurred.A left atrial appendage (laa) closure procedure was performed and a 30mm watchman laa closure device was implanted.The following weekend, the patient presented to the emergency room with stroke-like symptoms.A transesophageal echo (tee) showed a large thrombus on the device.Surgical intervention as performed to remove the clot and the watchman device was subsequently explanted and the laa was ligated.
Additional Manufacturer Narrative
B3 event date, d6b explant date, and h6 patient codes corrected.
Event or Problem Description
It was reported that thrombosis and a cerebral vascular accident occurred.A left atrial appendage (laa) closure procedure was performed and a 30mm watchman laa closure device was implanted.The following weekend, the patient presented to the emergency room with stroke-like symptoms.A transesophageal echo (tee) showed a large thrombus on the device.Surgical intervention as performed to remove the clot and the watchman device was subsequently explanted and the laa was ligated.It was further reported that a transient ischemic attack occurred and not a cerebral vascular accident.At the time of the event the patient was on novel oral anticoagulants (noac).The patient has been discharged.

• 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: 11270102
• Report Number: 2134265-2021-00991
• Device Sequence Number: 4607265
• Product Code: NGV
• UDI-Device Identifier: 08714729838258
• UDI-Public: 08714729838258
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted 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,Followup
• Report Date (Section B): 02/19/2021

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: 01/30/2023
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0025134719
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 02/19/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention