MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WATCHMAN ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL

Model Number	10373
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was enrolled in the option clinical study (watchman group) on (b)(6) 2020 with patient identifier (b)(6) and the procedure was performed 20 days later.It was reported that worsening atrial septal defect resulting in fatigue and shortness of breath occurred.Transthoracic echocardiography (tte) assessment on (b)(6) 2020 revealed a left ventricular ejection fraction of 60%.Transesophageal echocardiogram (tee) assessment also revealed one laa lobe with a windsock morphology with an ostium diameter of 30.6mm and laa length of 27.3mm.A double curve watchman access sheath (was) (lot # 25187139) was introduced and deployment of a 35 mm watchman flx delivery system (wds) was attempted.Compression was suboptimal and the device was removed.Another 31 mm wds was also introduced and was not released also due to suboptimal compression.The was considered too high to allow for deployment and was removed.A transseptal puncture was done again at a slightly more inferior position with the help of another anterior curve was (lot #25228986).The subject underwent successful placement of a 35 mm watchman flx closure device with complete laa seal.The patient was discharged home three days post procedure.Three hundred sixty-four (364) days post procedure, tte revealed two atrial septal defects (asd).The patient experienced fatigue and shortness of breath.The patient was not on any oral anticoagulants at the time of the event.There was one asd noted during the index procedure which turned large in size and iatrogenic, however, no action was taken at this time.The patient was started on warfarin/vka 43 days later.The patient was then admitted to the intensive care unit (icu) on (b)(6) 2022.Cardiothoracic surgery was performed on an unknown date.The patient was discharged home on (b)(6) 2022.
Additional Manufacturer Narrative
B5: describe event or problem - updated with additional narrative including procedural details and event resolution date.
Event or Problem Description
The patient was enrolled in the option clinical study (watchman group) on (b)(6) 2020 with patient identifier (b)(6) and the procedure was performed 20 days later.It was reported that worsening atrial septal defect resulting in fatigue and shortness of breath occurred.Transthoracic echocardiography (tte) assessment on (b)(6) 2020 revealed a left ventricular ejection fraction of 60%.Transesophageal echocardiogram (tee) assessment also revealed one laa lobe with a windsock morphology with an ostium diameter of 30.6mm and laa length of 27.3mm.A double curve watchman access sheath (was) (lot # 25187139) was introduced and deployment of a 35 mm watchman flx delivery system (wds) was attempted.Compression was suboptimal and the device was removed.Another 31 mm wds was also introduced and was not released also due to suboptimal compression.The was was considered too high to allow for deployment and was removed.A transseptal puncture was done again at a slightly more inferior position with the help of another anterior curve was (lot #25228986).The subject underwent successful placement of a 35 mm watchman flx closure device with complete laa seal.The patient was discharged home three days post procedure.Three hundred sixty-four (364) days post procedure, tte revealed two atrial septal defects (asd).The patient experienced fatigue and shortness of breath.The patient was not on any oral anticoagulants at the time of the event.There was one asd noted during the index procedure which turned large in size and iatrogenic, however, no action was taken at this time.The patient was started on warfarin/vka 43 days later.The patient was then admitted to the intensive care unit (icu) on (b)(6) 2022.Cardiothoracic surgery was performed on an unknown date.The patient was discharged home on (b)(6) 2022.It was further reported that aspirin and warfarin/vka were administered prior to the index procedure.The attempted 31mm closure device was not successfully implanted due to the release criteria not being met as a result of the positioning being too proximal and distal.The patient continued on aspirin and warfarin post implant.At the time of the asd event, the patient was on aspirin.The asd was considered as resolved on (b)(6) 2022.

• Brand Name: WATCHMAN ACCESS 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: 17899964
• Report Number: 2124215-2023-55369
• Device Sequence Number: 3379825
• Product Code: NGV
• UDI-Device Identifier: 08714729838210
• UDI-Public: 08714729838210
• 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
• 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): 01/12/2024

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: 02/18/2023
• Device Model Number: 10373
• Device Catalogue Number: 10373
• Device Lot Number: 0025228986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Race: White