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	08/26/2023
Type of Reportable Event	Serious Injury
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 a cerebral vascular accident occurred.A left atrial appendage closure procedure was performed, and a watchman flx closure device was implanted.Several years later the patient experienced five (5) strokes.
Additional Manufacturer Narrative
B3: bsc aware date used as event date is unknown.
Additional Manufacturer Narrative
B3: event date corrected from 9/20/2023 (estimated) to 8/26/2023 (exact).B5: additional information added.D4: model number, lot number, catalog, expiration date, and udi # added.D6a: implant date added.H4: manufacture date added.
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 a cerebral vascular accident occurred.A left atrial appendage closure procedure was performed, and a watchman flx closure device was implanted.Several years later the patient experienced five (5) strokes.It was further reported that over three (3) years post-implant the patient experienced hallucinations and was evaluated via magnetic resonance imaging (mri) where it was determined that the patient had been experiencing strokes.

• 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: 17821273
• Report Number: 2124215-2023-52201
• Device Sequence Number: 2302666
• Product Code: NGV
• UDI-Device Identifier: 08714729838234
• UDI-Public: 08714729838234
• 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: 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): 10/09/2023

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: 09/05/2021
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0022615132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2018
• 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