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	12/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Asap too study it was reported that a transient ischemic attack (tia) occurred.Prior to the index procedure, aspirin was administered.A left atrial appendage (laa) closure procedure was performed and a 21mm watchman laa closure device was implanted with 1mm largest residual jet size around device and deployed device diameter of 18 mm.After the implant the patient was started on clopidogrel.Aspirin was continued.On (b)(6) 2020, the patient was discharged.On (b)(6) 2022, 1058 days post index procedure, the patient presented emergently with slurred speech and right arm numbness.On the same day, the patient was hospitalized for further evaluation and treatment.A head computed tomography (ct) was performed and showed no acute findings.Electrocardiogram and laboratory test (blood work) were also performed as diagnostics.Neurology was consulted and the patient was diagnosed with transient ischemic attacks (tia), possibly secondary to microvascular ischemia.No corrective action was taken to treat the event.On (b)(6) 2022, the event was considered as resolved and on the same day, the patient was discharged.
Event or Problem Description
Asap too study.It was reported that a transient ischemic attack (tia) occurred.Prior to the index procedure, aspirin was administered.A left atrial appendage (laa) closure procedure was performed and a 21mm watchman laa closure device was implanted with 1mm largest residual jet size around device and deployed device diameter of 18 mm.After the implant the patient was started on clopidogrel.Aspirin was continued.On 09jan2020, the patient was discharged.On 01dec2022, 1058 days post index procedure, the patient presented emergently with slurred speech and right arm numbness.On the same day, the patient was hospitalized for further evaluation and treatment.A head computed tomography (ct) was performed and showed no acute findings.Electrocardiogram and laboratory test (blood work) were also performed as diagnostics.Neurology was consulted and the patient was diagnosed with transient ischemic attacks (tia), possibly secondary to microvascular ischemia.No corrective action was taken to treat the event.On 02dec2022, the event was considered as resolved and on the same day, the patient was discharged.It was further reported that the event lasted for thirty minutes.At the time of the event, the patient was on aspirin.During this time, lab test revealed inr value at 1.1 (reference range: 0.9-1.1).Magnetic resonance imaging (mri) of brain without contrast was recommended for further evaluation.Additionally, telemetry was also recommended, and the patient was started on iv fluids.Neuro checks were performed in every 6 hours and then patient was recommended to tilt the head 30 degree of bed.On 02dec2022, mri of brain was performed and following impressions were noted: no acute intracranial abnormality, the cerebral parenchyma demonstrated moderate periventricular white matter increased t2-weighted signal, which was nonspecific, but would be most consistent with microvascular disease and low signal on gre sequence within the bilateral frontal, parietal, temporal and occipital lobes remain unchanged.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15940969
• Report Number: 2124215-2022-51050
• Device Sequence Number: 12349113
• Product Code: NGV
• UDI-Device Identifier: 08714729838227
• UDI-Public: 08714729838227
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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
• Report Date (Section B): 12/08/2022

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: 03/03/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0023434634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2019
• 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: 76 YR
• Patient Sex: Male
• Patient Race: White