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); Obstruction/Occlusion (2422)
Date of Event	07/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: bsc aware date used as event date is unknown d6a: estimated based on reported information that device was implanted 4 years ago.
Event or Problem Description
It was reported that vessel occlusion occurred.A left atrial appendage (laa) closure procedure was performed, and a watchman closure device was implanted.Approximately four (4) years post-implant the patient experienced compression of the circumflex artery which the physician suspects is being caused by the implanted watchman closure device.
Additional Manufacturer Narrative
A1: patient identifier added.B2: patient date of birth and age at time of event added.B5: additional event details added.D4: model number, lot number, catalog number, expiration date, and unique identifier (udi) # added.H6: patient code of chest pain added.B3: bsc aware date used as event date is unknown.D6a: estimated based on reported information that device was implanted 4 years ago.
Event or Problem Description
It was reported that vessel occlusion occurred.A left atrial appendage (laa) closure procedure was performed, and a watchman closure device was implanted.Approximately four (4) years post-implant the patient experienced compression of the circumflex artery which the physician suspects is being caused by the implanted watchman closure device.It was further reported that the patient presented with chest pain.Angiography revealed mild circumflex stenosis at the level of the shoulder of the watchman closure device.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17364668
• Report Number: 2124215-2023-35451
• Device Sequence Number: 17416023
• Product Code: NGV
• UDI-Device Identifier: 08714729838234
• UDI-Public: 08714729838234
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/16/2023

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: 04/18/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0023668962
• 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: 06/30/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2019
• 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: 79 YR
• Patient Sex: Unknown