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

Model Number	10371
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was performed and a 30mm watchman laa closure device was implanted.The patient was discharged.The patient was readmitted (b)(6) 2020 through (b)(6) 2020 and then again on (b)(6) 2020 through (b)(6) 2020.During the first readmission the patient presented with weakness, edema, and worsening urine output (patient on home dialysis).A small pericardial effusion was seen on the echocardiogram.The patient was worked up for tamponade.An echo was performed which showed no tamponade.A tee was performed and no clot was present.On (b)(6) 2020, the patient was attempted to be cardioverted but this was unsuccessful.Repeat cardioversion attempt on (b)(6) 2020 was also unsuccessful.The patient was discharged home with plans to be seen as an outpatient.During the (b)(6) 2020 hospitalization the patient had a repeat echo and showed an increase in the pericardial effusion from previous studies.On (b)(6) 2020, the patient had a pericardiocentesis with removal of 1200cc of fluid with a drain left in place.The patient also had an ablation and pacemaker placed.The implanted device looked okay on echo and it is not believed the fluid is from the device, but rather from the patient being back in atrial fibrillation.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10905648
• Report Number: 2134265-2020-16186
• Device Sequence Number: 16948233
• Product Code: NGV
• UDI-Device Identifier: 08714729838258
• UDI-Public: 08714729838258
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/18/2021
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0023105509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 11/25/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention