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 (2100)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that thrombosis occurred.A left atrial appendage (laa) closure procedure was performed and a 30mm watchman laa closure device was implanted.The patient was on eliquis up until 45 days post implant, then aspirin 81mg and plavix until 6 months and then only aspirin 81mg after that.The 45-day follow-up transesophageal echocardiogram (tee) performed on (b)(6) 2020 was within normal limits.The 1-year follow-up computerized tomography (ct) scan performed on (b)(6) 2020 identified a laminar, non-mobile, device related thrombus between the threaded insert on the face of device and the limbus.The thrombus was mildly biased toward the limbus.Anticoagulation therapy is expected to resume and a follow-up tee will be performed in a few months.The patient is currently asymptomatic.

• 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: 11038423
• Report Number: 2134265-2020-18117
• Device Sequence Number: 13769460
• Product Code: NGV
• UDI-Device Identifier: 08714729838258
• UDI-Public: 08714729838258
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2020

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: 05/02/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0023736136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 12/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR