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	Chest Pain (1776); Thrombosis/Thrombus (4440)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a device related thrombus occurred.In (b)(6) 2022, a left atrial appendage (laa) closure procedure was performed using a 24mm watchman flx laa closure device with delivery system (wds).In (b)(6) 2022, the patient present to the hospital with chest pain.Transesophageal echocardiogram revealed a thrombus on the surface of the closure device.Oral anticoagulant medication was administered.In (b)(6) 2023, a thrombectomy was performed.The patient fully recovered and was discharged from the hospital.
Additional Manufacturer Narrative
Date of event - aware date of (b)(6) 2023 used as event date is unknown.
Additional Manufacturer Narrative
B3: date of event - aware date of 09jan2023 used as event date is unknown.B5 event description date of index procedure corrected.
Event or Problem Description
It was reported that a device related thrombus occurred.In (b)(6) 2022, a left atrial appendage (laa) closure procedure was performed using a 24mm watchman flx laa closure device with delivery system (wds).In (b)(6) 2022, the patient present to the hospital with chest pain.Transesophageal echocardiogram revealed a thrombus on the surface of the closure device.Oral anticoagulant medication was administered.In (b)(6) 2023, a thrombectomy was performed.The patient fully recovered and was discharged from the hospital.It was further reported the laa closure procedure took place in (b)(6) 2020.The closure device was noticeably tilted with a large mitral shoulder but no peri device leak was present.During a routine follow up examination in (b)(6) 2022, a device related thrombus was identified.The patient was restarted on eliquis.By (b)(6) 2022, the non mobile thrombus had not resolved and a thrombectomy was performed in (b)(6) 2023.
Event or Problem Description
It was reported that a device related thrombus occurred.In (b)(6) 2022, a left atrial appendage (laa) closure procedure was performed using a 24mm watchman flx laa closure device with delivery system (wds).In (b)(6) 2022, the patient present to the hospital with chest pain.Transesophageal echocardiogram revealed a thrombus on the surface of the closure device.Oral anticoagulant medication was administered.In (b)(6) 2023, a thrombectomy was performed.The patient fully recovered and was discharged from the hospital.It was further reported the laa closure procedure took place in (b)(6) 2020.The closure device was noticeably tilted with a large mitral shoulder but no peri device leak was present.During a routine follow up examination in (b)(6) 2022, a device related thrombus was identified.The patient was restarted on eliquis.By (b)(6) 2022, the non mobile thrombus had not resolved and a thrombectomy was performed in (b)(6) 2023.It was further reported that during a follow up transesophageal echocardiogram post thrombectomy, and the closure device was free from the presence of thrombus.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16197026
• Report Number: 2124215-2023-01111
• Device Sequence Number: 6066320
• Product Code: NGV
• UDI-Device Identifier: 08714729838241
• UDI-Public: 08714729838241
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2023

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: 02/11/2023
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0025200270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 01/24/2023; 01/30/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 01/27/2023; 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown
• Patient Race: White