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

Model Number	M635WU50310
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Codes	Stroke/CVA (1770); Fall (1848); Bone Fracture(s) (1870); Low Blood Pressure/ Hypotension (1914); Sepsis (2067); Confusion/ Disorientation (2553); Abdominal Distention (2601); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Facial Paralysis (4585); High White Blood Cell Count (4594)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported via clinical study: it was reported cerebral vascular accident (cva) and incomplete seal occurred.A left atrial appendage (laa) closure procedure was performed and a 31mm watchman flx closure device was implanted with complete seal noted.The patient was discharged on apixaban and aspirin.During the four (4) month follow up transesophageal echocardiogram (tee) performed on (b)(6) 2022, imaging showed incomplete laa seal of unknown jet size.On (b)(6) 2025, the patient presented to the hospital with a hip fracture following a ground-level fall two (2) days prior and admitted to the hospital.On (b)(6) 2025, lab findings demonstrated hypotension and marked leukocytosis.Computed tomography (ct) imaging of the abdomen and pelvis revealed colitis, and a seven-day antibiotic course was initiated.The event was reported as sepsis.On (b)(6) 2025 (1,408 days post-index procedure), the patient developed a stroke while on aspirin therapy.Clopidogrel was initiated in response.The following day, the patient developed facial droop, and a magnetic resonance imaging (mri) of the brain was performed which revealed ischemic stroke.On (b)(6) 2025, the hip fracture and sepsis events were considered resolved, and the patient was discharged.On (b)(6) 2025, clopidogrel medication was discontinued.
Additional Manufacturer Narrative
B5: information added h6 patient codes added: confusion/disorientation, appropriate code/term not available (used for hyponatremia and siadh (syndrome of inappropriate antidiuretic hormone secretion) as mentioned in the complaint summary, and abdominal distention.
Event or Problem Description
Reported via clinical study it was reported cerebral vascular accident (cva) and incomplete seal occurred.A left atrial appendage (laa) closure procedure was performed and a 31mm watchman flx closure device was implanted with complete seal noted.The patient was discharged on apixaban and aspirin.During the four (4) month follow up transesophageal echocardiogram (tee) performed on (b)(6) 2022, imaging showed incomplete laa seal of unknown jet size.On (b)(6) 2025, the patient presented to the hospital with a hip fracture following a ground-level fall two (2) days prior and admitted to the hospital.On (b)(6) 2025, lab findings demonstrated hypotension and marked leukocytosis.Computed tomography (ct) imaging of the abdomen and pelvis revealed colitis, and a seven-day antibiotic course was initiated.The event was reported as sepsis.On october 21, 2025 (1,408 days post-index procedure), the patient developed a stroke while on aspirin therapy.Clopidogrel was initiated in response.The following day, the patient developed facial droop, and a magnetic resonance imaging (mri) of the brain was performed which revealed ischemic stroke.On (b)(6) 2025, the hip fracture and sepsis events were considered resolved, and the patient was discharged.On (b)(6) 2025, clopidogrel medication was discontinued.It was further reported that on (b)(6) 2025, the patient was admitted to the hospital for increased confusion and acute delirium in the presence of hyponatremia, secondary to siadh (syndrome of inappropriate antidiuretic hormone secretion), as well as orthostatic hypotension and abdominal distention.This event was also noted to be related to the stroke event.On (b)(6) 2025, the patient was discharged.

• 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: 23728381
• Report Number: 2124215-2025-86779
• Device Sequence Number: 9210999
• Product Code: NGV
• UDI-Device Identifier: 08714729860518
• UDI-Public: (01)08714729860518(17)240926(10)28096101
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2024
• Device Model Number: M635WU50310
• Device Catalogue Number: M635WU50310
• Device Lot Number: 0028096101
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 12/17/2025
• Date Device Manufactured: 09/27/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Race: White