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	02/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a cerebral vascular accident (cva) occurred.A left atrial appendage (laa) closure procedure was performed and 4 watchman laa closure devices were attempted.During the procedure, 4 different closure devices were attempted as the patient had a difficult laa to support the watchman implant, so no device was implanted.The international normalized ratio (inr) was 1.5 during the procedure.The patient woke up 3 hours post procedure and had a stroke in which they were hospitalized for a week.The physician stated the patient could attempt a watchman flx closure device on a later date, but the patient declined this suggestion.The patient recovered and was doing well after this event.

• 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: 11901426
• Report Number: 2134265-2021-06905
• Device Sequence Number: 3687828
• Product Code: NGV
• UDI-Device Identifier: 08714729838258
• UDI-Public: 08714729838258
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/28/2021

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: 11/07/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0024738972
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 05/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other