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	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	11/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event - estimated as it was known the first event of a gap was noted in (b)(6) 2020, whereas, the stroke event occurred later in (b)(6) 2021.
Event or Problem Description
It was reported that a cerebral vascular accident (cva) occurred and that the closure device did not seal.A left atrial appendage (laa) closure procedure was performed and a 24mm watchman laa closure device was implanted.Only one partial recapture was performed prior to successful implantation of the closure device.On follow up transesophageal echocardiography in nov2020, a 6mm gap was noted on the mitral side of the closure device.On 01mar2021, it was reported that the patient experienced a cryptogenic stroke.No additional information is known at this time.

• 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: 12033315
• Report Number: 2134265-2021-07202
• Device Sequence Number: 3411475
• Product Code: NGV
• UDI-Device Identifier: 08714729838234
• UDI-Public: 08714729838234
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P130013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2021

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: 05/29/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0023879210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/21/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other