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

Device Problem Difficult to Open or Close (2921)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001); Pericardial Effusion (3271)

Event Date 05/09/2022

Event Type  Injury  

Event Description

Literature article.It was reported that there was a pericardial effusion.A left atrial appendage (laa) closure procedure was being performed.A watchman access system (was) was positioned and a 27mm 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.The closure device was deployed and all release criteria was met.The closure device was released from the core wire and successfully implanted in the laa of the patient.Post closure device release the physician noted that the patient had a moderate to large pericardial effusion.The patient became hypotensive and needed vasopressor support.The physician performed a pericardiocentesis and drained 600ml of blood from the patient.A transthoracic echocardiogram showed that the effusion was not improving and another 350ml of blood was removed from the patient over 30 minutes.The physician believed that there was a perforation of the la so the patient was brought to the operating room for open heart surgery.During surgery a perforation was noted and repaired.It was noted that the closure device had shifted in the laa and there was a peri-device leak.The surgeon removed the closure device from the patient and resected the laa.The patient fully recovered from this event and was discharged from the hospital doing well.

Manufacturer Narrative

D.Al rameni, i.S.De armas, a.Al rameeni, et al., case report: watchman procedure complicated by atrial perforation and device dislodgement, cardiovascular revascularization medicine, https://doi.Org/10.1016/j.Carrev.2022.05.009.

• Brand Name: WATCHMAN FLX LAA CLOSURE DEVICE & 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; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15422355
• MDR Text Key: 299924918
• Report Number: 2124215-2022-35698
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female