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	Thrombosis/Thrombus (4440)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that thrombosis occurred.A left atrial appendage (laa) closure procedure was performed and a 30mm watchman laa closure device was implanted with no leak noted.An anterior gutter was present at implant.Anti-coagulation was stopped at 45-day post-implant.At the routine 4-month transesophageal echo (tee), a device related thrombus on the device was noted on the side of the center pin on the face of the device leaning towards the anterior side, but not filling the gutter.The patient currently has no symptoms.The patient will restart xarelto and a repeat tee will be performed in approximately 3 months to see if the thrombus has resolved.

• 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: 11727216
• Report Number: 2134265-2021-05201
• Device Sequence Number: 19790970
• Product Code: NGV
• UDI-Device Identifier: 08714729838258
• UDI-Public: 08714729838258
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2021

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: 09/17/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0024448971
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/26/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR