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	Stroke/CVA (1770)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 event date: event date estimated as event reported to have occurred in (b)(6) 2022.
Event or Problem Description
The following event originated from social media, and therefore despite good faith efforts the information is often incomplete.Additionally, due to the limited information received through good faith efforts, this event may represent a duplicate of an event which was already known to boston scientific.It was reported via social media that a patient experienced a cerebral vascular accident.A left atrial appendage (laa) closure procedure was performed, and a 30mm watchman laa closure device was implanted on (b)(6) 2018.It was reported that in (b)(6) 2022, the patient had discontinued anticoagulation medication and experienced a cerebral vascular accident.The patient went to the emergency room and was admitted to the hospital for further assessment at that time.The patient has since been discharged and continues to follow up with their primary neurosurgeon every six months.No further information was provided.

• 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: 18144743
• Report Number: 2124215-2023-64042
• Device Sequence Number: 15172255
• Product Code: NGV
• UDI-Device Identifier: 08714729838258
• UDI-Public: 08714729838258
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2023

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: 03/13/2020
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0020403156
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Female