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	10/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a cerebral vascular accident.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 21mm watchman laa closure device & delivery system (wds) were used.The procedure was completed successfully and the closure device was implanted in the laa of the patient.There were no complications that were reported to have occurred.Post procedure the patient was noted to have left sided facial droop.The patient had a ct scan of their head that showed cerebral atrophy and microvascular ischemic change.A few days after this the patient had a magnetic resonance imaging procedure performed.It was noted that the patient had acute very mild left facial droop and a possible small ischemic event.The patient is still experiencing mild left facial droop and mild left side weakness.

• 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
• MDR Report Key: 10886802
• Report Number: 2134265-2020-15543
• Device Sequence Number: 14215245
• Product Code: NGV
• UDI-Device Identifier: 08714729838227
• UDI-Public: 08714729838227
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/23/2020

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: 12/18/2021
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0023108742
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 11/23/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other