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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
B2: estimated based on bsc aware date.B3: estimated based on bsc aware date.
Event or Problem Description
The patient was enrolled in the asap too study with patient identifier (b)(6)on (b)(6) 2020.It was reported that death occurred.A left atrial appendage closure procedure was performed on (b)(6) 2020.Initially, a 24mm watchman closure device was attempted, however release criteria were not met, and it was removed and exchanged for a second 24mm watchman closure device.Again, release criteria were not met, and it was removed and exchanged for a 27mm watchman closure device which was successfully implanted at the laa with a complete seal and deployed diameter of 23mm.The patient was discharged (b)(6) 2020.On an unknown date, unknown days post-index procedure, the patient died.
Additional Manufacturer Narrative
B2 date of death: updated to exact date; b3: updated to exact date; b5: updated.
Event or Problem Description
The patient was enrolled in the asap too study with patient identifier (b)(6) on (b)(6) 2020.It was reported that death occurred.A left atrial appendage closure procedure was performed on (b)(6) 2020.Initially, a 24mm watchman closure device was attempted, however release criteria were not met, and it was removed and exchanged for a second 24mm watchman closure device.Again, release criteria were not met, and it was removed and exchanged for a 27mm watchman closure device which was successfully implanted at the laa with a complete seal and deployed diameter of 23mm.The patient was discharged (b)(6) 2020.On an unknown date, unknown days post-index procedure, the patient died.It was further reported that the patient died approximately 4 years post-implant on (b)(6) 2024.

• Brand Name: WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
• Common Device Name: SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19071447
• Report Number: 2124215-2024-20792
• Device Sequence Number: 6900789
• Product Code: NGV
• UDI-Device Identifier: 08714729838241
• UDI-Public: 08714729838241
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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: 09/08/2022
• Device Model Number: 10371
• Device Catalogue Number: 10371
• Device Lot Number: 0024397501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Race: White