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	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) study.It was reported that device leak occurred.The patient was on regular aspirin and clopidogrel regimen prior to consent and screening for the study.Prior to the procedure, aspirin was administered.A left atrial appendage (laa) closure procedure was performed and a 33mm watchman laa closure device was implanted with complete laa seal and deployed device diameter of 27.3mm.After the implant the patient was started on clopidogrel.The patient was discharged on (b)(6) 2019.On (b)(6) 2020, the three-month follow-up core lab transesophageal echo (tee) evaluation revealed an incomplete laa seal with a jet size greater than 5mm.However, the size of largest residual jet around device was reported as 2mm.

• 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: 10934663
• Report Number: 2134265-2020-16645
• Device Sequence Number: 2478264
• Product Code: NGV
• UDI-Device Identifier: 08714729838265
• UDI-Public: 08714729838265
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0023139722
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/02/2020
• Patient Sequence Number: 1
• Patient Age: 78 YR