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	11/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) study.It was reported that a transient ischemic attack (tia) occurred.The patient was enrolled into the (b)(6) clinical study on (b)(6) 2017, and the procedure was performed twenty one days later.A 27mm watchman left atrial appendage (laa) closure device was implanted with a complete laa seal and deployed device diameter of 22.6mm.The patient was administered aspirin prior to the index procedure and after the index procedure, the patient was started on clopidogrel and aspirin was continued.The patient was discharged home the following day.One thousand four hundred fifty three (1453) days post index procedure, the patient presented emergently after a fall that occurred 20 minutes prior to hospitalization.The patient experienced dizziness at home, lost balance, and fell.No head injury or loss of consciousness was noted.The patient had slurred speech and facial droop for about 20 minutes, which was resolved when early medical service arrived.The patient denied any headache, blurred vision, facial asymmetry, numbness, or weakness.The patient was alert and oriented upon admission without any acute distress.The patient's nihss score was 0.The baseline nihss score on (b)(6) 2017 was 3.Head computed tomography (ct) revealed no evidence of intracranial hemorrhage and multiple infarcts were found to be stable.The patient was diagnosed with a tia, which was evaluated by a neurologist and the patient was hospitalized on the same day.The patient was on aspirin at the time of this event.The patient was initiated on rocephin.The event was considered resolved on the same day.Magnetic resonance imaging (mri) of the brain the next day revealed generalized cerebral atrophy consistent with the patient's age.No acute intracranial findings or ischemic infarct were noted.Chronic small right occipital lobe infarct and hemorrhage were noted.The neurological examination revealed the patient to be awake and alert.Two days after hospitalization, bilateral carotid ultrasound doppler revealed no evidence of carotid stenosis.The flow in both vertebral arteries were in cephalad direction.The patient was discharged home two days after hospitalization on aspirin.
Event or Problem Description
Asap too study.It was reported that a transient ischemic attack (tia) occurred.The patient was enrolled into the asap too clinical study on (b)(6) 2017, and the procedure was performed twenty one days later.A 27mm watchman left atrial appendage (laa) closure device was implanted with a complete laa seal and deployed device diameter of 22.6mm.The patient was administered aspirin prior to the index procedure and after the index procedure, the patient was started on clopidogrel and aspirin was continued.The patient was discharged home the following day.One thousand four hundred fifty three (1453) days post index procedure, the patient presented emergently after a fall that occurred 20 minutes prior to hospitalization.The patient experienced dizziness at home, lost balance, and fell.No head injury or loss of consciousness was noted.The patient had slurred speech and facial droop for about 20 minutes, which was resolved when early medical service arrived.The patient denied any headache, blurred vision, facial asymmetry, numbness, or weakness.The patient was alert and oriented upon admission without any acute distress.The patient's nihss score was 0.The baseline nihss score on (b)(6) 2017 was 3.Head computed tomography (ct) revealed no evidence of intracranial hemorrhage and multiple infarcts were found to be stable.The patient was diagnosed with a tia, which was evaluated by a neurologist and the patient was hospitalized on the same day.The patient was on aspirin at the time of this event.The patient was initiated on rocephin.The event was considered resolved on the same day.Magnetic resonance imaging (mri) of the brain the next day revealed generalized cerebral atrophy consistent with the patient's age.No acute intracranial findings or ischemic infarct were noted.Chronic small right occipital lobe infarct and hemorrhage were noted.The neurological examination revealed the patient to be awake and alert.Two days after hospitalization, bilateral carotid ultrasound doppler revealed no evidence of carotid stenosis.The flow in both vertebral arteries were in cephalad direction.The patient was discharged home two days after hospitalization on aspirin.It was further reported that 1453 days post index procedure, the patient was diagnosed with a urinary tract infection (uti) as the urine culture was positive for e.Coli pan sensitive and the patient was initiated on iv ceftriaxone.The patient was discharged home on (b)(6) 2021 on oral ceftriaxone in addition to aspirin.One day later, the patient was admitted to intensive inpatient rehabilitation to maximize function and to allow a safe transition home.The patient was independent for activities of daily living and utilized a rolling walker for ambulation prior to admission and the discharge plan was for support at modified independence.The uti was resolved six days after it was identified.
Event or Problem Description
Asap too study it was reported that a transient ischemic attack (tia) occurred.The patient was enrolled into the asap too clinical study on (b)(6) 2017, and the procedure was performed twenty one days later.A 27mm watchman left atrial appendage (laa) closure device was implanted with a complete laa seal and deployed device diameter of 22.6mm.The patient was administered aspirin prior to the index procedure and after the index procedure, the patient was started on clopidogrel and aspirin was continued.The patient was discharged home the following day.One thousand four hundred fifty three (1453) days post index procedure, the patient presented emergently after a fall that occurred 20 minutes prior to hospitalization.The patient experienced dizziness at home, lost balance, and fell.No head injury or loss of consciousness was noted.The patient had slurred speech and facial droop for about 20 minutes, which was resolved when early medical service arrived.The patient denied any headache, blurred vision, facial asymmetry, numbness, or weakness.The patient was alert and oriented upon admission without any acute distress.The patient's nihss score was 0.The baseline nihss score on (b)(6) 2017 was 3.Head computed tomography (ct) revealed no evidence of intracranial hemorrhage and multiple infarcts were found to be stable.The patient was diagnosed with a tia, which was evaluated by a neurologist and the patient was hospitalized on the same day.The patient was on aspirin at the time of this event.The patient was initiated on rocephin.The event was considered resolved on the same day.Magnetic resonance imaging (mri) of the brain the next day revealed generalized cerebral atrophy consistent with the patient's age.No acute intracranial findings or ischemic infarct were noted.Chronic small right occipital lobe infarct and hemorrhage were noted.The neurological examination revealed the patient to be awake and alert.Two days after hospitalization, bilateral carotid ultrasound doppler revealed no evidence of carotid stenosis.The flow in both vertebral arteries were in cephalad direction.The patient was discharged home two days after hospitalization on aspirin.It was further reported that 1453 days post index procedure, the patient was diagnosed with a urinary tract infection (uti) as the urine culture was positive for e.Coli pan sensitive and the patient was initiated on iv ceftriaxone.The patient was discharged home on (b)(6) 2021 on oral ceftriaxone in addition to aspirin.One day later, the patient was admitted to intensive inpatient rehabilitation to maximize function and to allow a safe transition home.The patient was independent for activities of daily living and utilized a rolling walker for ambulation prior to admission and the discharge plan was for support at modified independence.The uti was resolved six days after it was identified.It was further reported that 1640 days post index procedure, the patient was admitted to the emergency department with weakness which persisted for 1 week, and the patient was diagnosed with covid-19.No action was taken during that time.The patient was noted with mild slurred speech and dizziness 1647 days post index procedure.On the same day, a ct scan, laboratory tests, and electrocardiogram were performed, and the patient was diagnosed with a tia.The patient was on aspirin at the time of reported.The patient was then admitted to the hospital for further evaluation and treatment.The event was considered resolved on the same day.However, the second tia was not considered related to the watchman closure device.
Additional Manufacturer Narrative
B5: describe event or problem - updated.B7- other relevant history - updated.

• 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: 13014243
• Report Number: 2134265-2021-15622
• Device Sequence Number: 1893744
• Product Code: NGV
• UDI-Device Identifier: 08714729838241
• UDI-Public: 08714729838241
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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,Followup,Followup
• Report Date (Section B): 06/21/2022

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: 05/29/2020
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0020705470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 12/16/2021; 06/16/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 01/05/2022; 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2017
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Race: White