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

Model Number 10365

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Pericardial Effusion (3271)

Event Date 02/28/2019

Event Type  Injury  

Event Description

It was reported a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system and 24mm watchman laa closure device and delivery system were used.The closure device was deployed and noted to be very distal in the laa.It met release criteria and when it was being released, the physician noticed resistance.The closure device was successfully implanted; however, a pericardial effusion of 2cm was noticed on the transesophageal echocardiogram (tee).A pericardiocentesis was performed and approximately 4 liters of blood was aspirated and given back to the patient.The patient remained stable throughout the procedure.About one hour post procedure, no more blood could be aspirated and the pericardial effusion was no longer able to be seen on the tee.The patient was in good condition and has since been discharged from the hospital.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of the watchman delivery system (wds) and was snapped inside the related watchman access system (was).The device was bloody, and there was no implant with the wds.The core wire, tip, and sheath were microscopically and visually inspected.Inspection revealed tip damage (tricuts flared).The damage to the tip is typical of implant deployment.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

Event Description

It was reported a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A watchman access system and 24mm watchman laa closure device and delivery system were used.The closure device was deployed and noted to be very distal in the laa.It met release criteria and when it was being released, the physician noticed resistance.The closure device was successfully implanted; however, a pericardial effusion of 2cm was noticed on the transesophageal echocardiogram (tee).A pericardiocentesis was performed and approximately 4 liters of blood was aspirated and given back to the patient.The patient remained stable throughout the procedure.About one hour post procedure, no more blood could be aspirated and the pericardial effusion was no longer able to be seen on the tee.The patient was in good condition and has since been discharged from the hospital.

• Brand Name: WATCHMAN 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
• MDR Report Key: 8444836
• MDR Text Key: 139592980
• Report Number: 2134265-2019-02635
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• PMA/PMN Number: P130013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2020
• Device Model Number: 10365
• Device Catalogue Number: 10365
• Device Lot Number: 0021504618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Date Manufacturer Received: 04/18/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention