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	10/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Asap too study.It was reported that the patient experienced a transient ischemic attack.Prior to the procedure, the patient was on aspirin and clopidogrel.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) and a 33mm watchman laa closure device & delivery system (wds) were selected to be used.The procedure was successfully completed with the closure device implanted in the laa of the patient with a complete seal and a deployed device diameter of 28.2 mm.Post implant procedure clopidogrel was continued.Five (5) years post procedure the patient presented to the hospital with perioral numbness, slight right sided facial droop, and worsening of right arm weakness.The patient at the time was not on any anticoagulation medication.On the same day, a computed tomography (ct) head, ct head/neck were negative.Additionally, a chest x-ray was also performed.The following day, magnetic resonance imaging (mri) was performed, and it was negative.The patient was diagnosed with a transient ischemic attack.The patient was put on 81mg aspirin and 40mg atorvastatin in response to this event.Two days after presenting to the hospital the event was resolved.

• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15700280
• Report Number: 2124215-2022-44294
• Device Sequence Number: 6352842
• Product Code: NGV
• UDI-Device Identifier: 08714729838265
• UDI-Public: 08714729838265
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 10/31/2022

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: 09/30/2019
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0019786104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2016
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White