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 Codes	Transient Ischemic Attack (2109); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was enrolled in the (b)(6) study on (b)(6) 2019 with patient identifier rd (b)(6).It was reported that a transient ischemic attack (tia) occurred.A left atrial appendage (laa) closure procedure was performed.The patient underwent successful placement of a 21 mm watchman laa closure device with 1 mm jet size and deployed device diameter of 18 mm.Prior to the procedure aspirin was administered.After the procedure, the patient was started on clopidogrel and aspirin was continued.The patient was discharged the next day.717 days post-watchman implant procedure, the patient experienced a sixty minute episode of confusion with visual changes, which the patient attributed to migraine symptoms.Magnetic resonance imaging (mri) was performed and the patient was diagnosed with tia and was evaluated by a neurologist.No intervention took place.The suspected cause of the tia was unknown.On the same day the event was considered to be resolved.
Additional Manufacturer Narrative
B5: additional information added to narrative.H6: coding update.
Event or Problem Description
The patient was enrolled in the asap too study on (b)(6)2019 with patient identifier rd (b)(6).It was reported that a transient ischemic attack (tia) occurred.A left atrial appendage (laa) closure procedure was performed.The patient underwent successful placement of a 21 mm watchman laa closure device with 1 mm jet size and deployed device diameter of 18 mm.Prior to the procedure aspirin was administered.After the procedure, the patient was started on clopidogrel and aspirin was continued.The patient was discharged the next day.717 days post-watchman implant procedure, the patient experienced a sixty minute episode of confusion with visual changes, which the patient attributed to migraine symptoms.Magnetic resonance imaging (mri) was performed and the patient was diagnosed with tia and was evaluated by a neurologist.No intervention took place.The suspected cause of the tia was unknown.On the same day the event was considered to be resolved.It was further reported that the patient's symptoms were caused by the migraine.The site confirmed this event was not a tia and therefore there is no longer an allegation against the watchman.

• 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: 13386297
• Report Number: 2134265-2022-00820
• Device Sequence Number: 17377342
• 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): 06/08/2022

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): Initial
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 06/08/2022
• 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
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Race: White