MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FLX?; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	M635WU50240
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Paralysis (1997)
Date of Event	03/31/2025
Type of Reportable Event	Death
Event or Problem Description
The following event originated from a patient calling the watchman patient call center, 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 a cerebral vascular accident (cva) and death occurred.A left atrial appendage (laa) closure procedure was performed on (b)(6) 2023, and a 24mm watchman flx closure device was implanted.The patient passed away on (b)(6), 2025, following three strokes in a row.The first stroke was at the end of (b)(6) 2025, the second stroke was three weeks later leaving the patient paralyzed, and the third and final stroke occurred 1.5 months later and was described as a "massive stroke".The patient was discharged home after and then died which was two days following the final stroke.There were no further details reported.
Additional Manufacturer Narrative
With all the available information, boston scientific (bsc) concludes: device technical analysis: the watchman flx? remains implanted; therefore, returned device analysis could not be completed.Media review: despite multiple attempts, procedural angiographic media was not provided to assist in the investigation.Device history record review: a review was completed of the device history records (dhr) for the watchman flx?, part # m635wu50240 batch # 0031343982.The device was processed through all normal operational conditions and passed all acceptance activities.The dhr review did not identify any deviations or non-conformances that could have contributed to the event.Labeling review: there was no evidence to suggest that the device was used in a manner inconsistent with the labeling.Watchman flx? instructions for use (ifu) lists potential complications, risks and adverse events that may be associated with the use of this device which include cerebral vascular accident (cva) (paralysis) (hospitalization) and death.Risk review: a risk review was completed and confirmed that the events of cerebral vascular accident (cva) (paralysis) and death were defined in the risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
The following event originated from a patient calling the watchman patient call center, 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 a cerebral vascular accident (cva) and death occurred.A left atrial appendage (laa) closure procedure was performed on (b)(6) 2023, and a 24mm watchman flx closure device was implanted.The patient passed away on (b)(6) 2025, following three strokes in a row.The first stroke was at the end of (b)(6) 2025, the second stroke was three weeks later leaving the patient paralyzed, and the third and final stroke occurred 1.5 months later and was described as a "massive stroke".The patient was discharged home after and then died which was two days following the final stroke.There were no further details reported.

• Brand Name: WATCHMAN FLX?
• 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: 23234215
• Report Number: 2124215-2025-69547
• Device Sequence Number: 12979812
• Product Code: NGV
• UDI-Device Identifier: 08714729860495
• UDI-Public: (01)08714729860495(17)260329(10)31343982
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: 03/29/2026
• Device Model Number: M635WU50240
• Device Catalogue Number: M635WU50240
• Device Lot Number: 0031343982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 03/20/2026
• Date Device Manufactured: 03/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female