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

Model Number	M635WU60200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Endocarditis (1834); Fall (1848); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Sepsis (2067); Neck Pain (2433); Embolism/Embolus (4438)
Date of Event	11/03/2025
Type of Reportable Event	Death
Event or Problem Description
Reported via clinical study.It was reported that sepsis occurred.A left atrial appendage (laa) closure procedure had previously been performed, and a 20mm watchman flx pro closure device was implanted.11 days post index procedure, the patient presented to the emergency department with severe neck pain following a ground-level fall.Clinical workup revealed positive blood cultures for enterococcus faecalis.Transthoracic echocardiogram (tte) demonstrated possible vegetation, and magnetic resonance imaging (mri) of the brain showed evidence of septic emboli, with additional imaging suggesting possible cervical osteomyelitis.The patient was admitted and received intravenous antibiotic medication.The patient remained hospitalized from (b)(6) 2025, for treatment and monitoring related to sepsis and associated findings.The patient was discharged and the event is considered resolved.The site has indicated 'possible' relationship of the event with the study procedure.
Additional Manufacturer Narrative
B2: outcome added and date of death added.B5: information added and corrected.B7: information added.H1: type of reportable event changed from serious injury to death.H6 patient codes added: embolism/embolus, low blood pressure/hypotension, cardiac arrest.H6 impact code removed: hospitalization/prolonged hospitalization.H6 impact codes added: intensive care unit, resuscitation, death, unexpected medical intervention.
Event or Problem Description
Reported via clinical study: it was reported that sepsis occurred.A left atrial appendage (laa) closure procedure had previously been performed, and a 20mm watchman flx pro closure device was implanted.11 days post index procedure, the patient presented to the emergency department with severe neck pain following a ground-level fall.Clinical workup revealed positive blood cultures for enterococcus faecalis.Transthoracic echocardiogram (tte) demonstrated possible vegetation, and magnetic resonance imaging (mri) of the brain showed evidence of septic emboli, with additional imaging suggesting possible cervical osteomyelitis.The patient was admitted and received intravenous antibiotic medication.The patient remained hospitalized from (b)(6) 2025, through (b)(6) 2025, for treatment and monitoring related to sepsis and associated findings.The patient was discharged and the event is considered resolved.The site has indicated 'possible' relationship of the event with the study procedure.It was further corrected the patient was not discharged.The patient had a complicated medical picture that included sepsis secondary to infective endocarditis and was not improving during the intensive care stay during the hospitalization.The patient had sudden cardiopulmonary arrest that was sudden and unprovoked, which required resuscitation efforts including intubation and medication for hypotension.The patient's family decided to move the patient to comfort care measures only, and the patient died on (b)(6) 2025.
Additional Manufacturer Narrative
With all the available information, boston scientific (bsc) concludes: device technical analysis: the watchman flx? pro remains implanted; therefore, returned device analysis could not be completed.Device history record review: a review was completed of the device history records (dhr) for the watchman flx? pro, part#: m635wu60200, batch#: 0036943791.The device was processed through all normal operational conditions and passed all acceptance activities.The dhr review did not identify any deviations or non-conformance's 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? pro instructions for use (ifu) lists potential complications, risks and adverse events that may be associated with the use of this device which include infection (endocarditis, sepsis, fall, neck pain) (medication and imaging required) embolism, hypotension, arrhythmia (cardiopulmonary arrest) (intensive care, intubation) and death.Risk review a risk review was completed and confirmed that the events of infection (endocarditis, sepsis, fall, neck pain) embolism, hypotension, arrhythmia (cardiopulmonary arrest) 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
Reported via clinical study.It was reported that sepsis occurred.A left atrial appendage (laa) closure procedure had previously been performed, and a 20mm watchman flx pro closure device was implanted.11 days post index procedure, the patient presented to the emergency department with severe neck pain following a ground-level fall.Clinical workup revealed positive blood cultures for enterococcus faecalis.Transthoracic echocardiogram (tte) demonstrated possible vegetation, and magnetic resonance imaging (mri) of the brain showed evidence of septic emboli, with additional imaging suggesting possible cervical osteomyelitis.The patient was admitted and received intravenous antibiotic medication.The patient remained hospitalized from on (b)(6) 2025, for treatment and monitoring related to sepsis and associated findings.The patient was discharged and the event is considered resolved.The site has indicated 'possible' relationship of the event with the study procedure.It was further corrected the patient was not discharged.The patient had a complicated medical picture that included sepsis secondary to infective endocarditis and was not improving during the intensive care stay during the hospitalization.The patient had sudden cardiopulmonary arrest that was sudden and unprovoked, which required resuscitation efforts including intubation and medication for hypotension.The patient's family decided to move the patient to comfort care measures only, and the patient died on (b)(6) 2025.

• Brand Name: WATCHMAN FLX? PRO
• 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: 24251421
• Report Number: 2124215-2026-06176
• Device Sequence Number: 9657729
• Product Code: NGV
• UDI-Device Identifier: 00191506004583
• UDI-Public: (01)00191506004583(17)280710(10)36943791
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2026

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 Model Number: M635WU60200
• Device Catalogue Number: M635WU60200
• Device Lot Number: 0036943791
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/02/2026; 04/10/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/25/2026; 04/23/2026
• Date Device Manufactured: 07/11/2025
• 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; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 96 KG