MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN FLX?; system, appendage closure, left atrial

Model Number	M635WU50270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Death
Event or Problem Description
Reported via clinical study.It was reported that death occurred.A left atrial appendage (laa) closure procedure was performed, and a 27mm watchman flx closure device was implanted on (b)(6) 2021.The patient was discharged.On (b)(6) 2026, the patient passed away due to ongoing issues with malignancy.Per investigator, the causality to the study device is noted as not related.However, per sponsor, the causality of the study device has been assessed as possible as per the conventions.It was further reported that the cause of death is unknown.

• 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 H91 Y 868; EI H91 Y868
• Manufacturer Contact: mary crawford ; 4100 hamline ave n; arden hills, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50932951
• Report Number: 2124215-2026-51640
• Device Sequence Number: 9509087
• Product Code: NGV
• UDI-Device Identifier: 08714729860501
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 03/18/2024
• Device Model Number: M635WU50270
• Device Catalogue Number: M635WU50270
• Device Lot Number: 0026997608
• 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: 07/22/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 03/19/2021
• 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
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 234 LB