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	Stroke/CVA (1770)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Asap too study.It was reported that a cerebral vascular accident occurred.Prior to the procedure, aspirin and clopidogrel were administered.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) and a 27mm watchman laa closure device & delivery system (wds) were selected to be used.The procedure was completed successfully with the closure device implanted in the laa of the patient with a complete laa seal and deployed device diameter of 22.2 mm.The patient remained on aspirin and clopidogrel post procedure.The patient was discharged on (b)(6)2019.1251 days post procedure, the patient was noted to have a proximal descending aortic aneurysm.On the same day the patient was admitted to the hospital for further evaluation and treatment.The patient underwent proximal descending aortic aneurysm repair surgery.Post surgery the patient was also noted with pneumonia and sub-acute left cerebellar infarction.1255 post index procedure computed tomography of the patient's head revealed a sub-acute left cerebellar infarction.Ten days later the sub-acute left cerebellar infarction event was considered as resolved and the patient was discharged.
Additional Manufacturer Narrative
B5: describe event or problem - updated with additional information surrounding the event.G1: mfr contact first name, mfr contact last name, mfr contact phone number, mfr contact email - updated.
Event or Problem Description
Asap too study.It was reported that a cerebral vascular accident occurred.Prior to the procedure, aspirin and clopidogrel were administered.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) and a 27mm watchman laa closure device & delivery system (wds) were selected to be used.The procedure was completed successfully with the closure device implanted in the laa of the patient with a complete laa seal and deployed device diameter of 22.2 mm.The patient remained on aspirin and clopidogrel post procedure.The patient was discharged on (b)(6) 2019.1251 days post procedure, the patient was noted to have a proximal descending aortic aneurysm.On the same day the patient was admitted to the hospital for further evaluation and treatment.The patient underwent proximal descending aortic aneurysm repair surgery.Post surgery the patient was also noted with pneumonia and sub-acute left cerebellar infarction.1255 post index procedure computed tomography of the patient's head revealed a sub-acute left cerebellar infarction.Ten days later the sub-acute left cerebellar infarction event was considered as resolved and the patient was discharged.It was further reported that the patient was on aspirin and apixaban at the time of the event.The event term was classified as an undetermined stroke.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16886190
• Report Number: 2124215-2023-21087
• Device Sequence Number: 12305588
• Product Code: NGV
• UDI-Device Identifier: 08714729838241
• UDI-Public: 08714729838241
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 02/09/2024

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: 01/28/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0023263495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2019
• 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: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White