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	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	11/11/2020
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 21mm watchman laa closure device was implanted.Post implant, later that evening, there was an effusion noted around the heart, in the pericardium.A pericardiocentesis was performed and cardiovascular surgery was contacted.2,000 cc of blood was withdrawn and auto-transfused through a 16f sheath in the patient's right femoral vein.After the surgery team arrived, it was noted that there was thrombus around the heart.As the patient was on pressors, and also had chronic obstructive pulmonary disease, it was determined that the safest course of action would be to send the patient for cardiovascular surgery where a suture could be utilized to close the area that was bleeding.On (b)(6) 2020, the patient was doing well.
Event or Problem Description
It was reported that a pericardial effusion occurred.A left atrial appendage (laa) closure procedure was performed and a 21mm watchman laa closure device was implanted.Post implant, later that evening, there was an effusion noted around the heart, in the pericardium.A pericardiocentesis was performed and cardiovascular surgery was contacted.2,000 cc of blood was withdrawn and auto-transfused through a 16f sheath in the patient's right femoral vein.After the surgery team arrived, it was noted that there was thrombus around the heart.As the patient was on pressors, and also had chronic obstructive pulmonary disease, it was determined that the safest course of action would be to send the patient for cardiovascular surgery where a suture could be utilized to close the area that was bleeding.On (b)(6) 2020, the patient was doing well.It was further reported that there was a perforation in the distal aspect of the appendage.The pericardial effusion was discovered upon release of the device and was noted to be growing.A pericardiocentesis was performed.The patient was sent to surgery where the small perforation was repaired in the laa.The patient did well and was discharged 3 days post-operation.

• 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: 10960335
• Report Number: 2134265-2020-16979
• Device Sequence Number: 3189674
• Product Code: NGV
• UDI-Device Identifier: 08714729838227
• UDI-Public: 08714729838227
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 12/21/2020

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: 09/17/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0024453610
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 12/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention