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	04/23/2021
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.Upon discharge on (b)(6) 2020, the patient was prescribed xarelto and aspirin.The patient developed gastrointestinal bleeding on (b)(6) 2020 and was held for two days.The patient resumed coumadin and aspirin on (b)(6) 2020.On (b)(6) 2020, the patient stopped coumadin and started plavix and aspirin 81mg.On (b)(6) 2020, the patient was unwilling to come in for a transesophageal echocardiogram (tee) or see the physician due to covid.On (b)(6) 2020, the patient disconnected their phone number and did not respond to follow up requests for tee and to confirm compliance with medication.On (b)(6) 2021, the patient followed up with the physician and noted the patient was only on plavix at the patient's own doing.On (b)(6) 2021, tee was performed and thrombus was found on the watchman closure device.The patient was discharged home in stable condition on coumadin with lovenox bridging and plavix.The patient is scheduled to have repeat tee in 2-3 months.As of (b)(6) 2021, was regularly attending an anticoagulation clinic regularly to manage dosing and international normalized ratios (inr).The inr is still subtherapeutic currently and the dosage was increased.

• 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: 11842819
• Report Number: 2134265-2021-06107
• Device Sequence Number: 17058934
• Product Code: NGV
• UDI-Device Identifier: 08714729838241
• UDI-Public: 08714729838241
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/18/2021

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: 07/23/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0024159498
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 05/18/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR