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	12/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a transient ischemic accident occurred.A left atrial appendage (laa) closure procedure was performed.A 24mm watchman flx laa closure device with delivery system (wds) was used.Prior to the procedure the patient was not taking any antiplatelet therapy.During the implant procedure a closure device was placed but the position was too proximal so this device was removed and a second device was successfully placed.The procedure was completed and the patient was discharged with prescriptions for (b)(6) and clopidogrel.The patient experienced a seizure on 18december2019 and 29june2021.On (b)(6) 2021, 1142 days post implant procedure, the patient experienced slurred speech, right sided facial droop, and fatigue.Upon arrival in the emergency department, physical examination revealed no significant findings with normal motor, sensory and cranial nerve function.Neurology consultation recommended for ct scan of head, neck, and ct perfusion and suspect for transient ischemic attack.On the same day, ct scan revealed no acute infract, no intracranial hemorrhage, no effective mass, chronic thin bilateral hematoma.On (b)(6) 2021, ct of angio neck revealed no stenosis, no occlusion, and no perfusion.Therefore, the patient was recommended for mri for further evaluation.Minor facial paresis, mild to moderate decrease in sensory sensation, and drift in the motor function of the right and left leg were noted.The patient was diagnosed with a transient ischemic attack.On (b)(6) 2021, mri of head revealed no intracranial hemorrhage, no effective mass and right parietal craniotomy, chronic subdural hematoma.On (b)(6) 2021, the patient was in stable condition and discharged with prescriptions for keppra and phenytoin.
Event or Problem Description
It was reported that a transient ischemic accident occurred.A left atrial appendage (laa) closure procedure was performed.A 24mm watchman flx laa closure device with delivery system (wds) was used.Prior to the procedure the patient was not taking any antiplatelet therapy.During the implant procedure a closure device was placed but the position was too proximal so this device was removed and a second device was successfully placed.The procedure was completed and the patient was discharged with prescriptions for aspirin and clopidogrel.The patient experienced a seizure on (b)(6)2019 and (b)(6) 2021.On (b)(6) 2021, 1142 days post implant procedure, the patient experienced slurred speech, right sided facial droop, and fatigue.Upon arrival in the emergency department, physical examination revealed no significant findings with normal motor, sensory and cranial nerve function.Neurology consultation recommended for ct scan of head, neck, and ct perfusion and suspect for transient ischemic attack.On the same day, ct scan revealed no acute infract, no intracranial hemorrhage, no effective mass, chronic thin bilateral hematoma.On (b)(6) 2021, ct of angio neck revealed no stenosis, no occlusion, and no perfusion.Therefore, the patient was recommended for mri for further evaluation.Minor facial paresis, mild to moderate decrease in sensory sensation, and drift in the motor function of the right and left leg were noted.The patient was diagnosed with a transient ischemic attack.On (b)(6) 2021, mri of head revealed no intracranial hemorrhage, no effective mass and right parietal craniotomy, chronic subdural hematoma.On (b)(6) 2021, the patient was in stable condition and discharged with prescriptions for keppra and phenytoin.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13258806
• Report Number: 2134265-2022-00007
• Device Sequence Number: 14634443
• Product Code: NGV
• UDI-Device Identifier: 08714729838234
• UDI-Public: 08714729838234
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/14/2022

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: 07/25/2021
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0022427829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2021
• Initial Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Race: White