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

Model Number 10390

Device Problem Positioning Failure (1158)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 05/10/2023

Event Type  Injury  

Event Description

It was reported a device failure to expand, and procedural thrombus occurred.A left atrial appendage (laa) closure procedure was performed using a 31mm watchman flx laa closure device with delivery system (wds) and watchman fxd curve access system (was).During deployment, the closure device failed to fully expand.Shortly after deployment a thrombus was observed inside of the closure device.By performing a tug test, the operator was able to expand the closure device more fully however several struts on the closure device shoulder failed to open completely.The closure device met release criteria and the procedure concluded with the thrombus trapped within the implanted closure device.No patient complications were reported.

• Brand Name: WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM
• Type of Device: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16955571
• MDR Text Key: 315495047
• Report Number: 2124215-2023-23644
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 08714729860518
• UDI-Public: 08714729860518
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10390
• Device Catalogue Number: 10390
• Device Lot Number: 0030863407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR