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	Death (1802); Myocardial Infarction (1969)
Date of Event	06/21/2020
Type of Reportable Event	Death
Event or Problem Description
It was reported via social media that death occurred.A left atrial appendage (laa) closure procedure was performed and a 21mm watchman laa closure device was implanted.Nine days post-procedure, the patient had a heart attack and died.
Event or Problem Description
It was reported via social media that death occurred.A left atrial appendage (laa) closure procedure was performed and a 21mm watchman laa closure device was implanted.Nine days post-procedure, the patient had a heart attack and died.It was further reported that this was a challenging case as the watchman device did not seat well in the laa.A double curve truseal access sheath was used with a 24mm device initially, but this device would not stay in the laa when tugged.The double curve sheath was then used with a 21mm device hoping to seat it deeper, but it also failed the tug test.The double curve was exchanged for a single curve sheath and a new 21mm device was seated deeper and it passed the release criteria.Both intracardiac echo (ice) and transesophageal echo (tee) were used for this case.

• 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: 11130914
• Report Number: 2134265-2020-18674
• Device Sequence Number: 11596961
• Product Code: NGV
• UDI-Device Identifier: 08714729838227
• UDI-Public: 08714729838227
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2021

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: 11/27/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0024844937
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 02/02/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 80 YR