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

Model Number	M635WU60200
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device embolization occurred.A left atrial appendage closure procedure was performed on (b)(6) 2025 with implant of a 20mm watchman flx pro closure device.At the 45-day follow-up, imaging was performed which revealed the closure device had embolized to the descending aorta.The following day, the closure device was percutaneously explanted, and a new 20mm watchman flx pro closure device was implanted.No patient complications were reported.
Event or Problem Description
It was reported that device embolization occurred.A left atrial appendage closure procedure was performed on (b)(6) 2025 with implant of a 20mm watchman flx pro closure device.At the 45-day follow-up, imaging was performed which revealed the closure device had embolized to the descending aorta.The following day, the closure device was percutaneously explanted, and a new 20mm watchman flx pro closure device was implanted.No patient complications were reported.
Additional Manufacturer Narrative
With all the available information, boston scientific (bsc) concludes: device technical analysis: the watchman flx? pro was not returned; therefore, device analysis could not be completed.Device history record review: a review was completed of the device history records (dhr) for the watchman flx? pro, part # m635wu60200 batch # 0035931671.The device was processed through all normal operational conditions and passed all acceptance activities.The dhr review did not identify any deviations or non-conformances that could have contributed to the event.Labeling review: there was no evidence to suggest that the device was used in a manner inconsistent with the labeling.Watchman flx? pro instructions for use (ifu) lists potential complications, risks and adverse events that may be associated with the use of this device which include embolization (additional device required).Risk review: a risk review was completed and confirmed that the event of embolization was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Additional Manufacturer Narrative
B2: hospitalization added.B5: additional information added.G2: report source added.H6: additional impact code added.With all the available information, boston scientific (bsc) concludes: device technical analysis: the watchman flx? pro was not returned; therefore, device analysis could not be completed.Device history record review: a review was completed of the device history records (dhr) for the watchman flx? pro, part#: m635wu60200, batch#: 0035931671.The device was processed through all normal operational conditions and passed all acceptance activities.The dhr review did not identify any deviations or non-conformance's that could have contributed to the event.Labeling review: there was no evidence to suggest that the device was used in a manner inconsistent with the labeling.Watchman flx? pro instructions for use (ifu) lists potential complications, risks and adverse events that may be associated with the use of this device which include embolization (additional device required).Risk review: a risk review was completed and confirmed that the event of embolization was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.
Event or Problem Description
It was reported that device embolization occurred.A left atrial appendage closure procedure was performed on (b)(6) 2025 with implant of a 20mm watchman flx pro closure device.At the 45-day follow-up, imaging was performed which revealed the closure device had embolized to the descending aorta.The following day, the closure device was percutaneously explanted, and a new 20mm watchman flx pro closure device was implanted.No patient complications were reported.It was further reported via the watcman surpass pro registry that the patient was re-hospitalized as a result of this event.
Event or Problem Description
It was reported that device embolization occurred.A left atrial appendage closure procedure was performed on (b)(6) 2025 with implant of a 20mm watchman flx pro closure device.At the 45-day follow-up, imaging was performed which revealed the closure device had embolized to the descending aorta.The following day, the closure device was percutaneously explanted, and a new 20mm watchman flx pro closure device was implanted.No patient complications were reported.It was further reported via the watcman surpass pro registry that the patient was re-hospitalized as a result of this event.
Additional Manufacturer Narrative
B2: hospitalization added.B5: additional information added.G2: report source added.H6: additional impact code added.With all the available information, boston scientific (bsc) concludes: device technical analysis: the watchman flx? pro was not returned; therefore, device analysis could not be completed.Device history record review: a review was completed of the device history records (dhr) for the watchman flx? pro, part#: m635wu60200, batch#: 0035931671.The device was processed through all normal operational conditions and passed all acceptance activities.The dhr review did not identify any deviations or non-conformances that could have contributed to the event.Labeling review: there was no evidence to suggest that the device was used in a manner inconsistent with the labeling.Watchman flx? pro instructions for use (ifu) lists potential complications, risks and adverse events that may be associated with the use of this device which include embolization (additional device required, hospitalization or prolonged hospitalization).Risk review: a risk review was completed and confirmed that the event of embolization was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.

• Brand Name: WATCHMAN FLX? PRO
• 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: 24315620
• Report Number: 2124215-2026-07762
• Device Sequence Number: 11971349
• Product Code: NGV
• 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: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/28/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M635WU60200
• Device Catalogue Number: M635WU60200
• Device Lot Number: 0035931671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 04/13/2026; 04/05/2026; 05/22/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 04/16/2026; 04/22/2026; 05/28/2026
• Date Device Manufactured: 02/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Race: White