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	Material Integrity Problem (2978)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that thrombosis and implant fabric damage occurred.A left atrial appendage closure (laa) procedure was performed and a 30mm watchman laa closure device was implanted.During a follow-up transesophageal echocardiogram (tee) on (b)(6) 2020, a large device related thrombus (drt) was noted.On subsequent tees performed on (b)(6) 2020 and (b)(6) 2020, the drt was noted to be smaller.The patient had another tee performed on (b)(6) 2023 and it was thought there was a hole in the device.There appeared to be a flap of fabric that was no longer sutured to the struts and was flapping with each heartbeat.There appeared to be a jet coming from this area as well.No patient complications were reported.
Additional Manufacturer Narrative
B5: describe event or problem - updated.
Event or Problem Description
It was reported that thrombosis and implant fabric damage occurred.A left atrial appendage closure (laa) procedure was performed and a 30mm watchman laa closure device was implanted.During a follow-up transesophageal echocardiogram (tee) on (b)(6)2020, a large device related thrombus (drt) was noted.On subsequent tees performed on (b)(6)2020 and (b)(6) (b)(6) 2020, the drt was noted to be smaller.The patient had another tee performed on (b)(6) 2023 and it was thought there was a hole in the device.There appeared to be a flap of fabric that was no longer sutured to the struts and was flapping with each heartbeat.There appeared to be a jet coming from this area as well.No patient complications were reported.It was further reported that the patient does not tolerate blood thinners well due to the interaction with arthritis medication.The physician is potentially considering removal of the device.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16656062
• Report Number: 2124215-2023-14959
• Device Sequence Number: 12243425
• Product Code: NGV
• UDI-Device Identifier: 08714729838258
• UDI-Public: 08714729838258
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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
• Report Date (Section B): 04/11/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/04/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0024063725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Female