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	Stroke/CVA (1770); Headache (1880); Vomiting (2144)
Date of Event	05/01/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported a patient death occurred.In (b)(6) 2020, a left atrial appendage (laa) closure procedure was performed, and a 33mm watchman laa closure device was implanted.In (b)(6) 2023, the patient experienced a stroke and died.No further information is available at this time.
Additional Manufacturer Narrative
B2: date of death - estimated as death was reported to have occurred in (b)(6) 2023.B3: date of event - estimated as death was reported to have occurred in(b)(6) 2023.
Additional Manufacturer Narrative
B2 date of death - estimated as death was reported to have occurred in (b)(6) 2023.B3 date of event - estimated as death was reported to have occurred in (b)(6) 2023.
Event or Problem Description
It was reported a patient death occurred.In (b)(6) 2020, a left atrial appendage (laa) closure procedure was performed, and a 33mm watchman laa closure device was implanted.In (b)(6) 2023, the patient experienced a stroke and died.No further information is available at this time.It was further reported the patient experienced headache and vomiting prior to being hospitalized in (b)(6)2023.The patient cause of death was identified as a right m1 occlusion of the middle cerebral artery and a large, hemorrhagic, acute infarct of the right cerebral hemisphere.

• 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: 17127442
• Report Number: 2124215-2023-29434
• Device Sequence Number: 6457537
• Product Code: NGV
• UDI-Device Identifier: 08714729838265
• UDI-Public: 08714729838265
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

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: 01/15/2023
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0025053030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Death
• Patient Age: 80 YR
• Patient Sex: Female