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 Code	Thrombosis/Thrombus (4440)
Date of Event	05/14/2021
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.At the patient's 45 day follow up appointment, a 1.3 x 1.1 cm thrombus was found on the face of the watchman closure device via transesophageal echocardiography (tee).The patient noted that they missed a couple of days of taking their eliquis 5mg medication.Since the patient was noncompliant with the medication regiment, the patient was scheduled to continue on eliquis 5mg twice a day with an emphasis on not missing a dose.The patient was stable with no symptoms following this event and is scheduled for follow up tee 3 months later.

• 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: 11933784
• Report Number: 2134265-2021-06479
• Device Sequence Number: 14410785
• 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: 03/02/2023
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0025288044
• 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: 68 YR