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	Stroke/CVA (1770)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a cerebral vascular accident occurred.A left atrial appendage (laa) closure procedure was performed and a 33mm watchman laa closure device was implanted with a 4mm leak remaining.The 45-day follow-up transesophageal echo (tee) showed the leak to still be 4mm.The physician informed the patient a year after implant that the best option would be to close the leak and the patient refused to come in.The patient has now had two strokes and is finally interested in fixing the leak.Several tee's were taken after the 45-day follow-up tee that has showed progression of a larger leak now measuring almost 6mm wide.The patient is doing fine and will be getting a computed tomography (ct) scan soon to further evaluate the measurement of the leak.
Event or Problem Description
It was reported that a cerebral vascular accident occurred.A left atrial appendage (laa) closure procedure was performed and a 33mm watchman laa closure device was implanted with a 4mm leak remaining.The 45-day follow-up transesophageal echo (tee) showed the leak to still be 4mm.The physician informed the patient a year after implant that the best option would be to close the leak and the patient refused to come in.The patient has now had two strokes and is finally interested in fixing the leak.Several tee's were taken after the 45-day follow-up tee that has showed progression of a larger leak now measuring almost 6mm wide.The patient is doing fine and will be getting a computed tomography (ct) scan soon to further evaluate the measurement of the leak.It was further reported that the patient received 8 coils to seal off the leak and the patient is doing well.

• 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: 11402098
• Report Number: 2134265-2021-02519
• Device Sequence Number: 2191047
• Product Code: NGV
• UDI-Device Identifier: 08714729838265
• UDI-Public: 08714729838265
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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: 11/05/2016
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0016513847
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 05/03/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other