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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via literature 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.A transesophageal echocardiogram (tee) performed 45 days post procedure showed a peri-device leak around the watchman closure device.The patient was placed on anticoagulation in response to the leak.Repeated tee showed persistent residual peri-device leak with 5mm width along the coumadin ridge aspect of the watchman closure device.Computed tomography (ct) also showed a peri-device leak with a width of 6mm and complete opacification of the laa.Ct showed that the watchman closure device was displayed at the distal side of the laa, leaving the proximal section of the laa with a length of 10mm from the ostium.The patient was referred for management of the peri-device leak approximately three years post implant.Under general anesthesia, an angiogram of the left atrium was performed after transseptal puncture.Based on the measurements of the proximal and ostium sections of the laa, a 22mm non-boston scientific (bsc) closure device was selected to close the peri-device leak and was advanced into the proximal laa.Due to the interaction with the implanted watchman closure device, the non-bsc closure device was initially pushed out.The non-bsc device was then recaptured, and the delivery system was advanced adjacent to the watchman closure device under tee guidance.The lobe of the non-bsc closure device was released.An angiogram was performed, which showed no protruding of the non-bsc closure device.Following a tug test to confirm the stable position of the non-bsc closure device, the full non-bsc closure device was released into the laa.No further patient complications were reported, and the patient was discharged home the same day post procedure.
Additional Manufacturer Narrative
B3: date of event - estimated as 15 feb 2020 as the implant date was approximately three years prior to the article published in 2023 and the leak was first noticed 45 days post procedure.D6a: implant date - estimated as 01 jan2020 as the implant date was approximately three years prior to the article published in 2023, but the exact date of implant is unknown.Literature citation: yoon s-h, elgendy ay, dallan lap, filby sj.Amulet device implantation following incomplete left atrial appendage closure with watchman legacy device.Catheter cardiovasc interv.2023;1-4.Doi: 10.1002/ccd.30864.

• 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: 18567375
• Report Number: 2124215-2024-01579
• Device Sequence Number: 18172067
• Product Code: NGV
• UDI-Device Identifier: 08714729838234
• UDI-Public: 08714729838234
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/23/2024

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 Model Number: 10371
• Device Catalogue Number: 10371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 80 YR
• Patient Sex: Male