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	Muscle Weakness/Atrophy (1967); Transient Ischemic Attack (2109); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported via clinical study it was reported that the patient experienced a transient ischemic attack.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) and a 24mm watchman flx laa closure device & delivery system (wds) were selected to be used.The procedure was successfully completed with the closure device implanted in the laa of the patient with a complete laa seal and deployed device diameter of 18.6 mm.There were no patient complications that were reported to have occurred.The patient was discharged on aspirin (81mg/day) and ticagrelor (180mg/day).Five (5) years post procedure, the patient presented to an outside hospital with a complaint of left-sided extremity weakness.The patient was hospitalized for further evaluation.X-ray and labs were performed in response to the event.At the time of the event, the patient was on aspirin (81 mg/day).The patient was diagnosed with experiencing a transient ischemic attack.The event is ongoing.There have been no other complications that have been reported to have occurred.

• 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: 50735306
• Report Number: 2124215-2026-48731
• Device Sequence Number: 16117704
• Product Code: NGV
• UDI-Device Identifier: 08714729860495
• UDI-Public: (01)08714729860495(17)240513(10)27314612
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 09/18/2026

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: 05/13/2024
• Device Model Number: M635WU50240
• Device Catalogue Number: M635WU50240
• Device Lot Number: 0027314612
• 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: 08/27/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/11/2026
• Supplement Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 05/14/2021
• 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: Other; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Race: White