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 Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a perforation and a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was being performed.A trace baseline effusion was present prior to the procedure.After intubation of the patient, complete baseline echo images were obtained.Access was then obtained and a transseptal crossing was completed.The sl1 sheath was then exchanged for the anterior curve watchman access system (was) sheath, the patient was anticoagulated and a pigtail injection was completed.Upon injection, the ostium was marked, and a 30mm watchman laa closure device & delivery system (wds) sheath was advanced and deployed using the unsheathing technique.It was noted that the device did advance forward at the beginning of the deployment sequence; however, no changes in the pericardium were seen at the end of the case.The device was released after meeting release criteria and the procedure was finished.A filling defect was noted in the apex of the appendage with contrast injection, believed to be an air bubble.The patient was then extubated, and transferred to the recovery room where she hemodynamically decompensated about 90 minutes later.The physician completed a transthoracic echocardiogram (tte) and placed a pericardial drain percutaneously and drained 400cc.The patient has been stable since and neurologically intact.The middle lobe of the laa was assumed to have been injured in the process of device delivery.The drain was removed on (b)(6) 2020 and discharge was planned for (b)(6) 2020.

• 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: 11007299
• Report Number: 2134265-2020-17457
• Device Sequence Number: 3813307
• Product Code: NGV
• UDI-Device Identifier: 08714729838258
• UDI-Public: 08714729838258
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/14/2020

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: 01/30/2023
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0025135645
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/15/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR