MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	10371
Medical Device Problem Codes	Difficult to Open or Close (2921); Material Integrity Problem (2978); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: estimated based on event occurring in early 2020.Media review analysis: the media submitted is consistent with the complaint information in showing the watchman device tilt and flow inside device at late follow-up tee.However, it seems that the initial position of the watchman device was suboptimal, proximal and already tilted and it is difficult to determine if there was progression due to different imaging methods used.At the late follow-up imaging, color doppler indicated flow inside the device but this is likely due to flow through device where there is no fabric coverage.There is no evidence of any fabric damage.
Event or Problem Description
It was reported that device implant movement/shift occurred.A left atrial appendage (laa) closure procedure was performed and a 33mm watchman laa closure device was implanted.In early 2020, the patient was being seen for heart failure and a transesophageal echo (tee) noted the device appeared to be canted in the ostium of the laa with blood flow behind the device.The physician believed the fabric had been "eroded away" on the face of the device.The patient is being managed by the cardiology service and the current implanter there is inquiring with other colleagues about plugging the leak.No additional information is known at this time.

• 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: 11690241
• Report Number: 2134265-2021-04754
• Device Sequence Number: 14227510
• Product Code: NGV
• UDI-Device Identifier: 08714729838265
• UDI-Public: 08714729838265
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 04/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2021
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0021817134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/19/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other