MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	10371
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Codes	Endocarditis (1834); Presyncope (4410)
Date of Event	04/24/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
B3: event date is unknown, using boston scientific aware date.Literature citation: chaus, adib et al, watchman endocarditis: a novel complication.Wiley abstract.5161.
Event or Problem Description
Per literature, it was reported that: the patient had a chadsvasc score of 5 and a has-bled score of 3.A left atrial appendage (laa) closure procedure was being performed to treat paroxysmal non-valvular atrial fibrillation.A watchman access system (was) was positioned at the laa and a 21mm watchman closure device and delivery system (wds) were advanced.The wds was deployed and implanted without complications.One (1) month post index procedure, the patient presented with presyncope.Transesophageal echocardiogram (tee) imaging revealed an echo density in the aortic valve, posterior leaflet of the mitral valve and a possible echo density on the closure device.Coronary computed tomography angiography (ccta) demonstrated a small crescentic leak along the ieft posterior aspect of the closure device.Blood cultures were taken and grew staphylococcus epidermidis.In the physician's opinion, the closure device was thought to be the source of the endocarditis as post implantation imaging did not show any echo densities on the closure device or the valves.The patient was deemed a poor surgical candidate by the cardiothoracic surgery for closure device removal and the decision was made to continue intravenous antibiotics for six (6) weeks and then reevaluate for device removal.A few weeks later, the patient presented with septic shock and died shortly thereafter.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
• 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: 19219946
• Report Number: 2124215-2024-25253
• Device Sequence Number: 8198575
• Product Code: NGV
• UDI-Device Identifier: 08714729838227
• UDI-Public: 08714729838227
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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 Model Number: 10371
• Device Catalogue Number: 10371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Death; Other
• Patient Age: 88 YR
• Patient Sex: Female