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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 03/14/2023

Event Type  Injury  

Event Description

It was reported that a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 27mm watchman flx closure device and delivery system (wds) was inserted.The 27mm wds was deployed, however a transoesophageal echocardiography (tee) showed that the device needed to be reposition.A full recapture was performed, and the closure device was repositioned in the laa.The positioning was not successful, and an angiogram was performed for better visualization of the laa.A sweep was performed, and it was discovered that an existing baseline pericardial effusion had increased in size, the watchman devices were removed from the patient and the procedure was aborted.Pericardiocentesis was completed to treat the pericardial effusion and the patient remained stable throughout the procedure.The pericardial effusion reoccurred several hours later with hemodynamic instability, and the patient was taken to surgery.A perforation was discovered at the base of the posterolateral appendage which the physicians suspected occurred during the full recapture of the wds.The laa was ligated.The patient remains hospitalized.

• 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; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16628690
• MDR Text Key: 312138086
• Report Number: 2124215-2023-12519
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 08714729860501
• UDI-Public: 08714729860501
• 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: 03/28/2023

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
• Device Operator: Health Professional
• Device Model Number: 10390
• Device Catalogue Number: 10390
• Device Lot Number: 0027916871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Female