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	07/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: estimated based off report that event occurred in july 2021 d6a: estimated based off report that implant occurred in november 2020.
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 that stroke occurred.A left atrial appendage closure procedure was performed and a watchman closure device was implanted in november 2020.In july 2021, the patient experienced a mild cluster stroke and their pre-existing atrial fibrillation persisted.In january 2023, cardiac ablation was performed and in february 2023 cardioversion was performed.The patient experienced atrial flutter which was treated with cardiac ablation in july 2023.The patient's atrial fibrillation has stopped since then and normal sinus rhythm has been restored.
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 that stroke occurred.A left atrial appendage closure procedure was performed and a watchman closure device was implanted in (b)(6) 2020.In (b)(6) 2021, the patient experienced a mild cluster stroke and their pre-existing atrial fibrillation persisted.In (b)(6) 2023, cardiac ablation was performed and in (b)(6) 2023 cardioversion was performed.The patient experienced atrial flutter which was treated with cardiac ablation in (b)(6) 2023.The patient's atrial fibrillation has stopped since then and normal sinus rhythm has been restored.
Additional Manufacturer Narrative
D4: model number, lot number, catalog number, expiration date, udi # added; d6a: implant date corrected from (b)(6) 2020; h4: manufacture date added.

• 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: 17980531
• Report Number: 2124215-2023-57914
• Device Sequence Number: 11389034
• Product Code: NGV
• UDI-Device Identifier: 08714729838234
• UDI-Public: 08714729838234
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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: 02/17/2023
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0025222150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2020
• 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 Sex: Male