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 Low Blood Pressure/ Hypotension (1914); Perforation (2001); Tachycardia (2095); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 10/19/2022

Event Type  Injury  

Event Description

It was reported that there was a pericardial effusion.A left atrial appendage (laa) closure procedure was being performed.A watchman fxd curve access system (was) was positioned and a 20mm watchman flx laa closure device & delivery system (wds) were used.The physician positioned the was in the laa of the patient and then inserted the wds.While deploying the closure device in the laa the physician felt the wds shift.The closure device was deployed in an acceptable position.After this deployment it was noted that the patients blood pressure dropped, and they had an elevated heart rate.A transesophageal echocardiogram (tee) was performed which showed that there was a pericardial effusion with cardiac tamponade around the anterior and inferior left and right ventricle.The patient blood pressure continued to drop, so was given medication to treat this.The physician gave the patient protamine and performed a pericardiocentesis.1175ml of fluid was drained from the effusion and the patient was given 3 units of blood.A cardioversion procedure was performed twice before successfully helping the patient return to a sinus rhythm.The procedure was continued with the closure device released in the laa of the patient.The patients blood pressure improved, the pericardial effusion resolved, and the patient became hemodynamically stable.The patient was taken to the icu where they were monitored.The patient made a full recovery and was discharged home the next day with no other consequences or complications that 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; 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: 15672652
• MDR Text Key: 302404999
• Report Number: 2124215-2022-43416
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 08714729860488
• UDI-Public: 08714729860488
• 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: 10/26/2022

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: 0029143185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male