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	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a movement/shift occurred.A left atrial appendage (laa) closure procedure was performed and a 24mm watchman laa closure device was implanted.At the patient's 45 day follow up appointment, transesophageal echocardiography (tee) identified that the closure device was very proximal in position.The feet of the closure device were still in the laa, however, the physician felt the patient ran a risk of device embolization.The closure device was explanted from the patient with a 16 french sheath and a snare.The patient was discharged home the following day.The patient plans to return at the end of (b)(6) 2021 for another watchman implantation.

• 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: 12313608
• Report Number: 2134265-2021-10176
• Device Sequence Number: 14550970
• Product Code: NGV
• UDI-Device Identifier: 08714729838234
• UDI-Public: 08714729838234
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 08/12/2021

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: 04/10/2023
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0025446513
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 08/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Weight: 91