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	Stroke/CVA (1770); Death (1802)
Date of Event	09/02/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Date of death estimated based on reported several days later.
Event or Problem Description
It was reported that stroke and death occurred.A left atrial appendage (laa) closure procedure was performed and a 21mm watchman laa closure device & delivery system (wds) was implanted.Later that evening, approximately four hours post implant, stroke occurred.A neurological evaluation revealed a brain shift.The patient had symptoms of nausea and confusion.Although the stroke was hemorrhagic and unlikely related to the device, it may be related to the procedure.The patient was maintained on heparin at 300 range.Ct and mri were performed.Neuro surgery was offered to the patient but was declined.The patient was sent to hospice and passed several days later.

• 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: 10750327
• Report Number: 2134265-2020-14867
• Device Sequence Number: 3006602
• Product Code: NGV
• UDI-Device Identifier: 08714729838227
• UDI-Public: 08714729838227
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2023
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0025133026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 77 YR