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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Transient Ischemic Attack (2109)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was enrolled in the asap too study on (b)(6) 2019 with patient identifier (b)(6).It was reported that transient ischemic attack (tia) occurred.On (b)(6) 2019, a left atrial appendage (laa) closure procedure was performed, and the patient underwent successful placement of a 27 mm watchman closure device with a complete laa seal and deployed device diameter of 23.9 mm.Post implant the patient was prescribed aspirin and clopidogrel and was discharged the next day.Three days post implant, the patient presented to the emergency department with left sided weakness, right ocular changes and left arm tingling/numbness which had been waxing and waning.The patient was hospitalized for further evaluation on the same day.The patient's symptoms resolved prior to hospital admission.The patient was immediately started on a heparin drip.The same day the patient was evaluated by a neurologist.Neurology examination noted the patient to be alert, oriented, with cranial nerve assessment intact and motor assessment showing left pronator drift.Computed tomography of the head revealed no acute parenchymal hemorrhage or large cortical infarct.Magnetic resonance imaging (mri) of the neck revealed no significant stenosis or evidence of dissection.Mri of the brain revealed no significant stenosis or occlusion.The patient was diagnosed with tia.On (b)(6) 2019, aspirin and plavix were stopped, and the patient was started on intravenous heparin.Transesophageal echocardiography (tee) was performed which revealed complete seal of the implanted 27mm watchman closure device with no thrombus attached on the atrial facing surface and no thrombus in the left atrium.The patient was discharged on anticoagulation and antiplatelet therapy for 45 days and instructed to return for a repeat tee.

• 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: 18912423
• Report Number: 2124215-2024-14587
• Device Sequence Number: 15214527
• Product Code: NGV
• UDI-Device Identifier: 08714729838241
• UDI-Public: 08714729838241
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/08/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0023161585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Race: White